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Report for Clinical Trial NCT03228667

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

QUILT-3.055: A Phase IIb, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients Who Have Disease Progression Following an Initial Response to Treatment With PD-1/PD-L1 Checkpoint Inhibitor Therapy

This is a Phase IIb, single-arm, multicohort, open-label multicenter study of ALT-803 in combination with an FDA-approved PD-1/PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1/PD-L1 checkpoint inhibitor therapy. All patients will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus ALT-803 for up to 16 cycles. Each cycle is six weeks in duration. All patients will receive ALT-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.

NCT03228667 Non-Small Cell Lung Cancer Small Cell Lung Cancer Urothelial Carcinoma Head and Neck Squamous Cell Carcinoma Merkel Cell Carcinoma Melanoma Renal Cell Carcinoma Gastric Cancer Cervical Cancer Hepatocellular Carcinoma Microsatellite Instability Mismatch Repair Deficiency Colorectal Cancer
MeSH: Carcinoma, Merkel Cell Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Melanoma Colorectal Neoplasms Carcinoma, Squamous Cell Carcinoma, Hepatocellular Stomach Neoplasms Uterine Cervical Neoplasms Carcinoma, Renal Cell Small Cell Lung Carcinoma Carcinoma, Transitional Cell Squamous Cell Carcinoma of Head and Neck Microsatellite Instability
HPO: Carcinoma Cervical polyp Cervix cancer Clear cell renal cell carcinoma Cutaneous melanoma Hepatocellular carcinoma Melanoma Merkel cell skin cancer Neoplasm of the large intestine Neoplasm of the lung Neoplasm of the stomach Non-small cell lung carcinoma Papillary renal cell carcinoma Renal cell carcinoma Small cell lung carcinoma Squamous cell carcinoma

4 Interventions

Name: ALT-803 + Pembrolizumab

Description: Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks.

Type: Drug

Coh Cohort 1 Cohort 2 Cohort 3 Cohort 4

Name: ALT-803 + Nivolumab

Description: Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks.

Type: Drug

Cohort 1 Cohort 4

Name: ALT-803 + Atezolizumab

Description: Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks.

Type: Drug

Cohort 1 Cohort 4

Name: ALT-803 + Avelumab

Description: Patients will receive 10 mg/kg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks.

Type: Drug

Cohort 1 Cohort 4


Primary Outcomes

Description: Assess the anti-tumor activity of ALT-803 in combination with a PD-1/PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1/PD-L1 checkpoint inhibitors.

Measure: Objective Response Rate

Time: 24 months

Secondary Outcomes

Description: Assess time from first treatment to death resulting from cancer.

Measure: Disease-specific Survival

Time: 24 months

Description: Assess time from first treatment to death resulting from any cause.

Measure: Overall Survival

Time: 24 months

Description: Assess time to response

Measure: Time to Response

Time: 24 months

Description: Assess duration of response

Measure: Duration of Response

Time: 24 months

Description: Assess incidence of adverse events.

Measure: Incidence of Adverse Events

Time: 24 months

Description: Compare changes in QOL scores from baseline.

Measure: Quality of Life (QOL)

Time: 24 months

Description: Assess amount of time disease does not get worse after first treatment.

Measure: Progression-free Survival

Time: 24 months

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Patients with BRAF V600E mutation-positive melanoma were not required to have received prior BRAF inhibitor therapy; OR unresectable or metastatic melanoma with progression, refractory to ≥ 2 doses of ipilimumab (3 mg/kg or higher) and, if BRAF V600 mutation-positive, a BRAF or MEK inhibitor, and disease progression within 24 weeks following the last dose of ipilimumab. --- V600E ---



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Cervical polyp
Cervix cancer
Genes 4
CDKN1B CXCR4 SRY STK11
Clear cell renal cell carcinoma
Genes 1
NOD2
Cutaneous melanoma
Genes 15
HRAS MITF CDKN2A BRAF NRAS NRAS WRN CDKN2A CXCR4 BAP1 POLH CDK4 ERCC3 XPC MC1R
Hepatocellular carcinoma
Genes 65
AHCY CTNNB1 CASP10 IGF2R JAG1 CASP8 HFE BMP2 HFE MLH1 PMS2 POU2AF1 HMBS FAH MSH6 SLC25A13 RASGRP1 EPCAM UROD AXIN1 TCF4 TP53 IL12A PRKCD SLC37A4 TGFBR2 SEMA4A JAK2 FAN1 FAS BMPR1A FAS KRAS FAH SPIB MSH2 HMBS MST1 MLH3 G6PC SPRTN SLC37A4 PIK3CA PDGFRL SERPINA1 TNFSF15 ATP7B IGF2 ABCB11 FASLG IL12RB1 SLC25A13 IRF5 RPS20 MET PIK3CA MMEL1 HFE H19 PMS1 F5 GPR35 APC TJP2 TNPO3
Melanoma
Genes 98
MGMT NRAS POT1 NRAS XPA CTSC BRCA1 SDHC ERCC4 CXCR4 RAD51C CDKN2B ERCC3 XPC PALLD ERCC2 ERCC2 CHEK2 CDKN2A RAD51D GNAQ SDHD KRAS MBTPS2 BAP1 BAP1 CYSLTR2 RNF43 BAP1 CDKN2A PTPN11 CDK4 BRCA2 ERCC3 MITF TERF2IP ERCC4 CHEK2 BRCA1 TRPV3 POT1 OCA2 TERT CDKN2A AKT1 CDKN2A SF3B1 ERCC6 ERCC5 ERCC5 MDM2 BRCA2 BAP1 GNA11 ACD BRIP1 HRAS MRE11 BRAF TYR TP53 KLLN SEC23B PTEN PIK3CA XPA PERP MITF RAF1 BRAF POLH TP53 BARD1 NRAS SMAD4 RAD50 DDB2 ERCC2 NBN TERT MC1R SLC45A2 WRN PALB2 DDB2 PALB2 CDKN2A SDHB MC1R RAD51 TP53 XPC ERCC3 PTEN CDKN2A POLH CDK4 MC1R
Merkel cell skin cancer
Neoplasm of the large intestine
Genes 120
FLCN SDHC MLH1 PMS2 APC EPCAM SDHC PALLD SRC BUB1 APC GREM1 NTHL1 PMS1 PTEN SDHB MSH6 APC KIT SDHD KRAS BMPR1A FAN1 CTNNB1 MSH3 POLD1 KRAS RNF43 KEAP1 DICER1 DLC1 BMPR1A MSH2 MSH6 PIK3CA CDKN2A FGFR3 BMPR1A MUTYH PIK3CA BMPR1A EP300 FOXE1 ENG SMAD7 AXIN2 CHEK2 MLH1 RPS20 BRCA1 RPS19 PRKAR1A APC GPR35 MLH1 AKT1 POLE SMAD4 KIT TP53 TRIP13 COL14A1 MDM2 SMAD4 POLE BRCA2 AKT1 MSH6 HABP2 NRAS MUTYH BUB1B DOCK8 TGFBR2 STK11 AXIN2 EPCAM BUB3 DCC AXIN2 TCF4 KLLN MSH2 APC TP53 SEC23B PTEN TGFBR2 SEMA4A POLD1 PIK3CA PDGFRA MINPP1 APC SH3KBP1 BMPR1A TP53 BUB1 AAGAB SMAD4 BMPR1A MST1 MLH3 MSH2 PALB2 FLCN SDHA PMS2 SDHB BUB1B MSH2 MLH1 CEP57 MLH3 TP53 PTPRJ PMS1 APC CDKN2A APC
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Neoplasm of the stomach
Genes 75
CASP10 IL1B SMAD4 KIT IL1RN TRIP13 MGMT SMAD4 FLCN AKT1 BCL10 SUFU MSH6 APC SDHC NRAS CDKN2B BUB1B SRC BUB1 ACD APC KLF6 APC MSH3 STK11 SDHB APC BUB3 DCC KRAS KIT MSH2 TP53 SEMA4A BAP1 PDGFRA CTNNB1 MITF MSH3 BMPR1A BUB1 DLC1 PIK3CA FGFR3 BMPR1A IRF1 MUTYH PTCH2 SDHA BMPR1A CDK4 CDKN2A EP300 BUB1B ENG FGFR2 AXIN2 TREX1 TERF2IP MC1R ERBB2 CEP57 RPS20 PTPRJ PRKAR1A PIK3CA POT1 PTCH1 CHEK2 TERT APC MLH1 CDH1 APC
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1
Papillary renal cell carcinoma
Genes 8
MET LMNA MINPP1 FOXE1 CDC73 FH HABP2 PRCC
Renal cell carcinoma
Genes 75
CCND1 TSC2 COL14A1 VHL HNF1B MET FLCN AKT1 SDHC HABP2 SDHAF2 NRAS FLCN SRC CDC73 FH APC PRCC SLC49A4 STK11 SDHB DCC TSC1 KLLN HNF1B SLC25A11 TP53 SDHD SEC23B BAP1 PTEN HNF1A KIF1B MAX PIK3CA VHL RNF139 MINPP1 CTNNB1 BUB1 RET KEAP1 DICER1 AAGAB DLC1 FN1 PIK3CA NOD2 SDHC FGFR3 FH TMEM127 VHL FLCN VHL OGG1 EP300 FOXE1 SDHB BUB1B AXIN2 SDHA MITF SDHD TFE3 FH IFNG PTPRJ LMNA HNF4A DLST MDH2 SDHB AKT1 FLCN
Small cell lung carcinoma
Squamous cell carcinoma
Genes 79
COL7A1 WNT10A CDKN2A GJB6 FDPS LZTS1 GTF2H5 TERT NLRP1 ERCC5 NUTM1 ERCC2 RSPO1 LAMA3 TMC8 CTSC ING1 RECQL4 GJB2 ERCC2 TGFBR2 ERCC4 LAMC2 LAMB3 MPLKIP TARS1 ERCC3 XPC DOCK8 BLM NTHL1 TYR PSENEN WRAP53 GTF2E2 IL7 RNF6 SLC17A9 TNFRSF10B DKC1 POLH RECQL4 BLM BRD4 KRT5 TMC6 TERC ERCC2 SASH1 WNT10A MC1R CIB1 SLC45A2 MVD WRN KRT14 DDB2 RNF113A DCC FERMT1 TYR COL7A1 ERCC3 ERCC3 COL7A1 MMP1 COL7A1 GJB2 SLX4 MMP1 LMNA MVK TINF2 WWOX GJB2 OCA2 CIB1 POLH STAT1