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Report for Clinical Trial NCT03639714

Developed by Shray Alag, 2020.
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:Adenocarcinoma Carcinoma, Transitional Cell

4 Interventions

Name: GRT-C901

Description: a patient-specific neoantigen cancer vaccine prime
Type: Biological
Group Labels: 2

Phase 1 Phase 2 Cohorts

Name: GRT-R902

Description: a patient-specific neoantigen cancer vaccine boost
Type: Biological
Group Labels: 2

Phase 1 Phase 2 Cohorts

Name: nivolumab

Description: anti-PD-1 monoclonal antibody
Type: Biological
Group Labels: 2

Phase 1 Phase 2 Cohorts

Name: ipilimumab

Description: anti-CTLA-4 monoclonal antibody
Type: Biological
Group Labels: 2

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 and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease - 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 or allergy or hypersensitivity to study drug components - 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