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Report for Clinical Trial NCT04310397

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Altering Adjuvant Therapy Based on Pathologic Response to Neoadjuvant Dabrafenib and Trametinib (ALTER-PATH NeoDT)

This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. Patients who achieve a pathologic complete response after 8 weeks of neoadjuvant dabrafenib and trametinib will receive adjuvant dabrafenib and trametinib. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as spartalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving dabrafenib, trametinib, and spartalizumab may help to control melanoma.

NCT04310397 Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8
MeSH:Melanoma Skin Neoplasms
HPO:Cutaneous melanoma Melanoma Neoplasm of the skin

4 Interventions

Name: Dabrafenib

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (dabrafenib, trametinib, surgery, spartalizumab)

Name: Spartalizumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (dabrafenib, trametinib, surgery, spartalizumab)

Name: Therapeutic Conventional Surgery

Description: Undergo surgery
Type: Procedure
Group Labels: 1

Treatment (dabrafenib, trametinib, surgery, spartalizumab)

Name: Trametinib

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (dabrafenib, trametinib, surgery, spartalizumab)


Primary Outcomes

Description: Will be estimated with a 95% confidence interval by using the Kaplan-Meier method.

Measure: Relapse-free survival (RFS) rate

Time: up to 12 months

Secondary Outcomes

Description: The rate of grade 3+ adverse events will be tabulated and presented by group.

Measure: Incidence of adverse events

Time: Up to 2 years

Description: Will be reported with 95% confidence intervals, and Cox regression models will be used to assess the association between similar covariates.

Measure: Overall survival

Time: up to 2 years

Description: Will be reported with 95% confidence intervals, and Cox regression models will be used to assess the association between similar covariates.

Measure: Distant metastasis-free survival

Time: up to 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. --- V600E ---

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. --- V600E --- --- V600K --- --- V600E ---

Only cases where a complete surgical resection with tumor- free margins can safely be achieved are defined as resectable - BRAF mutation-positive melanoma (V600E or V600K) based on report from a Clinical Laboratory Improvement Act (CLIA) certified laboratory - Patients must have measurable disease, defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Patients who have been previously treated in the adjuvant setting with ipilimumab or interferon alpha or investigational vaccines for melanoma will be eligible for treatment after a 28 day wash-out period - Patients who have previously received anti PD-1 in the adjuvant setting will be allowed if it has been six months or longer since previous drug exposure - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Women of childbearing potential, defined as all women physiologically capable of becoming pregnant will be required to use highly effective methods of contraception during dosing and for 150-days after stopping treatment with spartalizumab. --- V600E ---


2 V600K

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. --- V600E --- --- V600K ---

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. --- V600E --- --- V600K --- --- V600E --- --- V600K ---

Only cases where a complete surgical resection with tumor- free margins can safely be achieved are defined as resectable - BRAF mutation-positive melanoma (V600E or V600K) based on report from a Clinical Laboratory Improvement Act (CLIA) certified laboratory - Patients must have measurable disease, defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Patients who have been previously treated in the adjuvant setting with ipilimumab or interferon alpha or investigational vaccines for melanoma will be eligible for treatment after a 28 day wash-out period - Patients who have previously received anti PD-1 in the adjuvant setting will be allowed if it has been six months or longer since previous drug exposure - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Women of childbearing potential, defined as all women physiologically capable of becoming pregnant will be required to use highly effective methods of contraception during dosing and for 150-days after stopping treatment with spartalizumab. --- V600E --- --- V600K ---



HPO Nodes


HPO:
HP:0008069: Neoplasm of the skin
Genes 277
TGFBR2 DOCK8 KRT17 PORCN ERCC4 OCA2 PTEN SDHC SUFU RNF6 KRT6B PIK3CA TNFRSF1B DDB2 KRT14 SDHD FASLG COL1A1 CARMIL2 LRRC8A BAP1 NF1 FLT4 NRAS LAMC2 RSPO1 OCRL TP53 NTHL1 PTEN NF1 FH LAMB3 COL7A1 PERP FH NRAS TINF2 SLC17A9 RECQL4 PTCH2 RPS20 CD79B KRT17 BMPR1A MLH1 NF1 GJB3 LZTS1 MSH3 SUFU GNA14 IKBKG PTCH1 KIT HRAS BRAF APC PRKAR1A MMP1 KRT17 TP53 KEAP1 SMO PTCH1 ERCC5 MVD TERC PTEN SEMA4A CD79A SMARCB1 GJB2 KIT FLT4 KRT9 MC1R SEC23B VEGFC ERCC3 FGFR1 BLNK TNFRSF1B MSH6 TCF3 PLCD1 MEN1 FAS KRAS CTSC RECQL4 CD28 CDKN2B WWOX CTLA4 COL7A1 HRAS CDKN2A TP53 WNT10A NLRP1 ERCC2 IFNG MBTPS2 MDM2 KRAS GTF2E2 MLH1 STAT1 TMC8 SNAI2 BMPR1A CDKN1A KDSR CD28 CYLD ERCC2 ERCC4 NRAS DCLRE1C SLC45A2 PMS1 MITF MSH3 NUTM1 IL7 PIK3CA ERCC3 SDHC PTCH2 MLH1 CIB1 MSH6 CDKN2A NF1 CIB1 TNFRSF10B NF2 APC SLCO2A1 BLM GJA1 GTF2H5 PIK3CA TARS1 CXCR4 CDK4 PIK3R1 CYLD GJC2 GPR143 DDB2 LAMA3 SDHB MVK PMVK PIK3CA EPCAM GJB2 NF2 MSH2 WRAP53 MEN1 RASA1 KRAS LMNA CTNNB1 CDKN1B POLH GJB6 MPLKIP IL6 CXCR4 NOTCH3 TSC2 AKT1 PSENEN PMS2 RASGRP1 CASP10 ERCC3 MC1R SDHB KIT RMRP PTEN TGFBR2 PDGFRB CYLD RNF113A ALX3 BLM CTNNB1 FH KIT STIM1 TYR TMC6 HRAS CHEK2 KRT1 DICER1 DKC1 MSH2 COL7A1 NRAS PTEN FDPS PRKCD NRAS CDKN2A XPC WNT10A SEC23B XPA CDKN1B ERCC2 HPGD ERCC5 SLX4 TNFRSF4 FCN3 MMP1 ECM1 USF3 LMNA XPC NTHL1 KRT16 KIT PDGFB FAN1 ERCC4 SPRED1 PDGFB ING1 FERMT1 MLH1 KLLN ERCC2 GJB4 MSH6 APC TERT POLH BRD4 WRN SASH1 TMC6 MSH2 HRAS APC PMS2 ERCC3 KIT CTLA4 KLLN IGHM STK4 FAS GJB2 MLH3 TRPV3 CDKN2C IGLL1 TYR MSH2 NF2 COL7A1 AKT1 DCC FLCN PTCH1 TSC1 CDKN2A KRT5 PRKAR1A
Protein Mutations 4
D299G P13K V600E V600K
SNP 0