A Study of a Personalized Neoantigen Cancer Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03639714 |
Recruitment Status :
Active, not recruiting
First Posted : August 21, 2018
Last Update Posted : September 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer Colorectal Cancer Gastroesophageal Adenocarcinoma Urothelial Carcinoma | Biological: GRT-C901 Biological: GRT-R902 Biological: nivolumab Biological: ipilimumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 214 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | February 13, 2019 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Phase 1
|
Biological: GRT-C901
a patient-specific neoantigen cancer vaccine prime Biological: GRT-R902 a patient-specific neoantigen cancer vaccine boost Biological: nivolumab anti-PD-1 monoclonal antibody
Other Name: Opdivo Biological: ipilimumab anti-CTLA-4 monoclonal antibody
Other Name: Yervoy |
Experimental: Phase 2 Cohorts
|
Biological: GRT-C901
a patient-specific neoantigen cancer vaccine prime Biological: GRT-R902 a patient-specific neoantigen cancer vaccine boost Biological: nivolumab anti-PD-1 monoclonal antibody
Other Name: Opdivo Biological: ipilimumab anti-CTLA-4 monoclonal antibody
Other Name: Yervoy |
- Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months) ]
- Objective Response Rate (ORR) in Phase 2 using RECIST v1.1 [ Time Frame: Initiation of study treatment until disease progression (up to approximately 27 months) ]
- Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902 [ Time Frame: Up to approximately 6 months ]
- Measure the immune response to neoantigens encoded by GRT-C901 and GRT-R902 [ Time Frame: Baseline to end of treatment (up to approximately 12 months) ]
- Objective Response Rate (ORR) in Phase 1 using RECIST v1.1 [ Time Frame: Initiation of study treatment until disease progression (up to approximately 4 years) ]
- Duration of response (DOR) using RECIST v1.1 [ Time Frame: Initiation of study treatment until disease progression (up to approximately 4 years) ]
- Clinical benefit rate (using RECIST v1.1) [ Time Frame: Initiation of study treatment until disease progression (up to approximately 4 years) ]
- Progression-free survival (PFS) [ Time Frame: Up to approximately 4 years ]
- Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
- Percentage of patients for whom vaccine is successfully manufactured and timeframe for vaccine manufacturing [ Time Frame: Study enrollment to initiation of study treatment (up to approximately 6 months) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
-
Patients with the indicated advanced or metastatic solid tumor as follows:
- NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible)
- GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
- mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
- CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
- 18 years of age or older
- ECOG Performance Status 0 or 1
- Lesion amenable to biopsy
- Measurable disease according to RECIST v1.1
- Have adequate organ function, as measured by laboratory values (criteria listed in protocol)
Exclusion Criteria:
-
Tumors with genetic characteristics as follows:
- For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
- For CRC and GEA, patients with known MSI-high disease based on institutional standard
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639714
United States, Arizona | |
Mayo Clinic Arizona | |
Phoenix, Arizona, United States, 85054 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10017 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Ohio | |
The Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 | |
United States, Tennessee | |
Tennessee Oncology | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Cancer Specialists | |
Fairfax, Virginia, United States, 22031 | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | |
Melbourne, Victoria, Australia, 3000 |
Responsible Party: | Gritstone bio, Inc. |
ClinicalTrials.gov Identifier: | NCT03639714 |
Other Study ID Numbers: |
GO-004 |
First Posted: | August 21, 2018 Key Record Dates |
Last Update Posted: | September 1, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
neoantigen cancer vaccine personalized neoantigen cancer vaccine GRT-C901 GRT-R902 immunotherapy |
nivolumab ipilimumab PD-1 CTLA-4 |
Adenocarcinoma Carcinoma, Transitional Cell Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |