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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03639714 |
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Recruitment Status :
Recruiting
First Posted : August 21, 2018
Last Update Posted : March 28, 2019
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Sponsor:
Gritstone Oncology, Inc.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Gritstone Oncology, Inc.
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Brief Summary:
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.
| 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 |
Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations can present peptides containing these mutations as non-self antigens in the context of HLA on the tumor cell surface. A fraction of mutated peptides result in neoantigens capable of generating T-cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a personalized cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901 first followed by GRT-R902) to stimulate an immune response. This study will explore the safety and early clinical activity of this patient-specific immunotherapy intended to induce T-cell responses specific for neoantigens.
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
Experimental: Phase 1
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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
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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 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
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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
- 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:
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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 MSI disease
- 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.
Information from the National Library of Medicine
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
Contacts
| Contact: Andy Ferguson | 857-327-9816 | aferguson@gritstone.com | |
| Contact: Cynthia Voong | 510-871-6104 | cvoong@gritstone.com |
Locations
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Aurelie Desgardin adesgard@medicine.bsd.uchicago.edu | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Michael Comiskey mc4375@cumc.columbia.edu | |
| United States, Tennessee | |
| Tennessee Oncology | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Dee McComb davinia.mccomb@sarahcannon.com | |
| United States, Virginia | |
| Virginia Cancer Specialists | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Claudia Phillips claudia.phillips@usoncology.com | |
Sponsors and Collaborators
Gritstone Oncology, Inc.
Bristol-Myers Squibb
| Responsible Party: | Gritstone Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT03639714 History of Changes |
| Other Study ID Numbers: |
GO-004 |
| First Posted: | August 21, 2018 Key Record Dates |
| Last Update Posted: | March 28, 2019 |
| Last Verified: | March 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Gritstone Oncology, Inc.:
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neoantigen cancer vaccine personalized neoantigen cancer vaccine GRT-C901 GRT-R902 immunotherapy |
nivolumab ipilimumab PD-1 CTLA-4 |
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Adenocarcinoma Carcinoma, Transitional Cell Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Vaccines Nivolumab Ipilimumab Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |