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Report for Clinical Trial NCT03639714
Developed by Shray Alag, 2020.
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.
NCT03639714 Non Small Cell Lung Cancer Colorectal Cancer Gastroesophageal Adenocarcinoma Urothelial Carcinoma
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
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