SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT00337467 (13) NCT00098293 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT01614470 (10) NCT01423812 (10) NCT00358917 (10) NCT04415268 (10) NCT00511381 (10) NCT03911713 (9) NCT02742519 (9) NCT02725567 (9) NCT03045523 (9) NCT00438152 (9) NCT01102972 (9) NCT02971839 (9) NCT00740064 (9) NCT02605954 (9) NCT00379405 (9) NCT01562847 (9) NCT02616783 (9) NCT04272242 (9) NCT02445053 (9) NCT00242840 (9) NCT02724527 (9) NCT04209465 (9) NCT04585737 (8) NCT02082977 (8) NCT00112775 (8) NCT00383318 (8) NCT03659214 (8) NCT03631732 (8) NCT00118898 (8) NCT01888562 (8) NCT02633189 (8) NCT03565692 (8) NCT03843775 (8) NCT01161576 (8) NCT02167165 (8) NCT00344461 (8) NCT04519398 (7) NCT02154490 (7) NCT03232892 (7) NCT00650832 (7) NCT04549025 (7) NCT00440947 (7) NCT02784639 (7) NCT03572140 (6) NCT01237444 (6) NCT00532168 (6) NCT01102569 (6) NCT04424368 (6) NCT01414985 (6) NCT00525733 (6) NCT02308332 (6) NCT01487265 (6) NCT00049933 (5) NCT02389920 (5) NCT03351699 (5) NCT04197934 (5) NCT02272998 (5) NCT00122590 (5) NCT04204330 (5) NCT02450591 (5) NCT01173029 (5) NCT02675829 (5) NCT02858921 (5) NCT01914484 (5) NCT00187733 (5) NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT01282151 (3) NCT03058094 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02282267 (2) NCT02684591 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT00525473 (2) NCT03333343 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00834665 (2) NCT00969137 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT00005541 (2) NCT01242813 (2) NCT02906020 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT03720665 (2) NCT04309019 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT00226551 (2) NCT03239145 (2) NCT04511533 (2) NCT02191891 (2) NCT04586270 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03977194 (2) NCT03991013 (2) NCT02500927 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT01841463 (2) NCT04429542 (2) NCT03865511 (2) NCT01218477 (2) NCT03205267 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT01998295 (2) NCT03586453 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) NCT00953706 (2) NCT02346955 (2) NCT03795688 (2) NCT02011945 (2) NCT00857675 (2) NCT00028262 (2) NCT02355431 (2) NCT02495233 (2) NCT04575415 (2) NCT03468985 (2) NCT00230087 (2) NCT02017600 (2) NCT04146298 (2) 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NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT01074398 (1) NCT04500717 (1) NCT03134131 (1) NCT01004497 (1) NCT02455167 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) NCT00867139 (1) NCT03363139 (1) NCT01936051 (1) NCT02341131 (1) NCT00037076 (1) NCT00582907 (1) NCT02169869 (1) NCT03284684 (1) NCT04204473 (1) NCT01074359 (1) NCT01400191 (1) NCT04530565 (1) NCT03530319 (1) NCT04146402 (1) NCT02658682 (1) NCT04241835 (1) NCT03133234 (1) 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SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01744171

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells.

NCT01744171 Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma
MeSH:Melanoma Skin Neoplasms
HPO:Cutaneous melanoma Melanoma Neoplasm of the skin

2 Interventions

Name: Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine

Description: Given ID
Type: Biological
Group Labels: 1

Treatment (recombinant hsp110-gp100 chaperone complex vaccine)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (recombinant hsp110-gp100 chaperone complex vaccine)


Primary Outcomes

Description: DLT is defined as grade 3 or 4 toxicity or grade 3 injection site toxicity, with the exception of grade 3 rigors/chills which will be tolerated for 48-72 hours if attributable to vaccine reaction.

Measure: MTD of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4

Time: Up to 30 days after the last vaccine dose

Secondary Outcomes

Description: Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.

Measure: Objective tumor response according to RECIST version 1.1

Time: Up to 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.. Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Melanoma Skin Neoplasms PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. --- V600E ---

Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.. Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Melanoma Skin Neoplasms PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. --- V600E --- --- V600E ---

Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.. Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Melanoma Skin Neoplasms PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. --- V600E --- --- V600E --- --- V600E ---

Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.. Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Melanoma Skin Neoplasms PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. --- V600E --- --- V600E --- --- V600E --- --- V600E ---

Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.. Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Melanoma Skin Neoplasms PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. --- V600E --- --- V600E --- --- V600E --- --- V600E --- --- V600E ---

Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.. Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Inclusion Criteria: - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) Exclusion Criteria: - Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Melanoma Skin Neoplasms PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. --- V600E --- --- V600E --- --- V600E --- --- V600E --- --- V600E --- --- V600E ---



HPO Nodes


HPO:
HP:0008069: Neoplasm of the skin
Genes 288
KRT5 MLH1 KIT MLH1 PTEN CDKN2A COL7A1 VEGFC NRAS RECQL4 KRT1 ECM1 PRKAR1A NLRP1 CYLD CTSC NRAS SMO COL7A1 NF2 DDB2 PIK3CA STAT1 GJB2 HRAS LAMA3 TARS1 TERT PRKAR1A LMNA BMPR1A PDGFB STK4 BAP1 PMS1 PTEN XPA MSH2 KRAS CTNNB1 SUFU FERMT1 KLLN FCN3 PERP CD28 NOTCH3 IKBKG OCA2 GJB6 IL7 OCRL TMC6 LAMC2 GTF2E2 NF1 CREBBP WNT10A HRAS HRAS CTLA4 SMARCE1 MSH3 CTLA4 RMRP RSPO1 BAP1 GPR143 ERCC2 TSC1 CARMIL2 ERCC5 SLC17A9 MLH3 TGFBR2 MBTPS2 ERCC2 NF1 FLCN FAN1 RASA1 MVK TNFRSF4 GNA14 BRD4 TP53 PTCH2 MSH2 LRRC8A SDHC ERCC3 PTCH1 IGHM LMNA ALX3 PLCD1 PTCH1 CIB1 CD79A ERCC3 TRPV3 IGLL1 CDKN2A CD79B PRKCD POLH KDSR CTNNB1 KRT6B NRAS IL7 BLNK PDGFB CYLD KRT14 SLCO2A1 RASGRP1 FH ERCC3 SEC23B DKC1 IL6 MPLKIP PMVK NTHL1 EPCAM MSH3 TP53 FGFR1 SNAI2 MEN1 TINF2 CD28 ERCC4 TYR NF1 WRAP53 MVD PTEN EP300 KRT17 KRT17 APC GJB2 BLM PMS2 KLLN GJB2 FASLG KIT USF3 PTEN TGFBR2 MITF WRN HRAS CYLD NRAS FH SDHD GJA1 MSH2 MMP1 DCC TYR MSH6 TERT GJB3 PIK3CA IFNG ERCC4 WNT10A ERCC2 CREBBP RPS20 GNAS NRAS SDHB RECQL4 SLX4 TMC8 ERCC5 GJB4 WWOX MSH2 NF2 FAS SPRED1 FDPS POLH SUFU NF2 MSH6 KRT6B FLT4 FAS BRAF KRT17 AKT1 BMPR1A LAMB3 RNF6 APC BAP1 ERCC2 SMARCB1 PIK3CA PDGFRB NF1 SEMA4A NUTM1 PTCH1 PTCH2 TNFRSF1B FLT4 KRT9 KRAS KIT BLM KRT16 KRAS PIK3CA KRT17 MC1R CIB1 CXCR4 PORCN AKT1 TMC6 DICER1 TERC CDK4 SEC23B TNFRSF1B XPC MLH1 ING1 PTEN MSH6 CXCR4 KIT KRT6A CDKN2A MC1R DDB2 PSENEN TRAF7 MMP1 TNFRSF10B KRT16 DCLRE1C TSC2 NF1 ERCC3 APC SDHC SMO SDHB TCF3 AKT1 KEAP1 KIT COL7A1 RNF113A PIK3CA SASH1 SLC45A2 FH MLH1 PIK3R1 IVNS1ABP DMPK ERCC4 GTF2H5 PMS2 CDKN1B STIM1 APC GJC2 LZTS1 DOCK8 HPGD XPC COL1A1 TMC8 CASP10 KIT NTHL1
Protein Mutations 4
D299G P13K V600E V600K
SNP 0