SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03639714

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

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.

NCT03639714 Non Small Cell Lung Cancer Colorectal Cancer Gastroesophageal Adenocarcinoma Urothelial Carcinoma
MeSH: Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Adenocarcinoma Carcinoma, Transitional Cell
HPO: Neoplasm of the large intestine Non-small cell lung carcinoma

4 Interventions

Name: GRT-C901

Description: a patient-specific neoantigen cancer vaccine prime

Type: Biological

Phase 1 Phase 2 Cohorts

Name: GRT-R902

Description: a patient-specific neoantigen cancer vaccine boost

Type: Biological

Phase 1 Phase 2 Cohorts

Name: nivolumab

Description: anti-PD-1 monoclonal antibody

Type: Biological

Phase 1 Phase 2 Cohorts

Name: ipilimumab

Description: anti-CTLA-4 monoclonal antibody

Type: 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
Non-small cell lung carcinoma
Genes 2
TP53 BAP1