SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT03639714
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical
activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination
with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer,
microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic
urothelial cancer.
Name: GRT-C901
Description: a patient-specific neoantigen cancer vaccine primeType: Biological
Phase 1 Phase 2 Cohorts
Name: GRT-R902
Description: a patient-specific neoantigen cancer vaccine boostType: Biological
Phase 1 Phase 2 Cohorts
Name: nivolumab
Description: anti-PD-1 monoclonal antibodyType: Biological
Phase 1 Phase 2 Cohorts
Name: ipilimumab
Description: anti-CTLA-4 monoclonal antibodyType: Biological
Phase 1 Phase 2 Cohorts
Primary Outcomes
Measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
Measure: Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
Time: Initiation of study treatment until disease progression (up to approximately 27 months)
Measure: Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902
Time: Up to approximately 6 months
Secondary Outcomes
Measure: Measure the immune response to neoantigens encoded by GRT-C901 and GRT-R902
Time: Baseline to end of treatment (up to approximately 12 months)
Measure: Objective Response Rate (ORR) in Phase 1 using RECIST v1.1
Time: Initiation of study treatment until disease progression (up to approximately 4 years)
Measure: Duration of response (DOR) using RECIST v1.1
Time: Initiation of study treatment until disease progression (up to approximately 4 years)
Measure: Clinical benefit rate (using RECIST v1.1)
Time: Initiation of study treatment until disease progression (up to approximately 4 years)
Measure: Progression-free survival (PFS)
Time: Up to approximately 4 years
Measure: Overall survival (OS)
Time: Up to approximately 4 years
Measure: Percentage of patients for whom vaccine is successfully manufactured and timeframe for vaccine manufacturing
Time: Study enrollment to initiation of study treatment (up to approximately 6 months)
Purpose: Treatment
Allocation: Non-Randomized
Sequential Assignment
There is one SNP
SNPs
1 V600E
For CRC, patients with a known BRAF V600E mutation or patients with peritoneal
carcinomatosis
- Patients with known central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a
vaccination
- Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant
bruising or bleeding following IM injections or blood draws
Complete inclusion and exclusion criteria are listed in the clinical study protocol. --- V600E ---
HPO Nodes
HPO:Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1 hr>Non-small cell lung carcinoma
Genes 2
TP53 BAP1 hr>