| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Solid Tumor Shared Neoantigen-Positive Solid Tumors | Biological: GRT-C903 Biological: GRT-R904 Biological: nivolumab Biological: ipilimumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 144 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors |
| Actual Study Start Date : | July 18, 2019 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
Experimental: Phase 1
|
Biological: GRT-C903
a shared neoantigen cancer vaccine prime
Biological: GRT-R904 a shared neoantigen cancer vaccine boost
Biological: nivolumab anti-PD-1 monoclonal antibody
Biological: ipilimumab anti-CTLA-4 monoclonal antibody
|
Experimental: Phase 2
|
Biological: GRT-C903
a shared neoantigen cancer vaccine prime
Biological: GRT-R904 a shared neoantigen cancer vaccine boost
Biological: nivolumab anti-PD-1 monoclonal antibody
Biological: ipilimumab anti-CTLA-4 monoclonal antibody
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with the indicated advanced or metastatic solid tumor as follows:
BRAF_G466V // CTNNB1_S37F // CTNNB1_S45F // CTNNB1_S45P // CTNNB1_T41A // ERBB2_Y772_A775dup // KRAS_G12C or NRAS_G12C // KRAS_G12D or NRAS_G12D // KRAS_G12V // KRAS_G13D // KRAS_Q61H or NRAS_Q61H // KRAS_Q61K or NRAS_Q61K // KRAS_Q61L or NRAS_Q61L // KRAS_Q61R or NRAS_Q61R // TP53_K132E // TP53_K132N // TP53_R213L // TP53_R249M // TP53_S127Y
Exclusion Criteria:
Tumors with genetic characteristics as follows:
Complete inclusion and exclusion criteria are listed in the clinical study protocol.
| Contact: Andy Ferguson | 857-327-9816 | aferguson@gritstone.com |
| United States, Arizona | |
| Mayo Clinic Arizona | Recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: New Patient Services 800-826-4673 | |
| UCLA Medical Center | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: Clinical Trials Referral Office 310-206-2632 | |
| United States, Florida | |
| Mayo Clinic Florida | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| United States, Illinois | |
| University of Chicago Medicine, Comprehensive Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Belen Martinez-Caro Aguado | |
| Contact Phase1trials@medicine.bsd.uchicago.edu | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Alaina Lileton liletona@karmanos.org | |
| United States, Minnesota | |
| Mayo Clinic Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| United States, New York | |
| Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Lisa Olmos cancerclinicaltrials@cumc.columbia.edu | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Shirin Pillai | |
| Contact pillais@mskcc.org | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Robert Haskins robert.haskins@fccc.edu | |
| United States, Tennessee | |
| Tennessee Oncology | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Dee McComb davinia.mccomb@sarahcannon.com | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Seema Prasad | |
| Contact SPrasad1@mdanderson.org | |
| United States, Virginia | |
| Virginia Cancer Specialists | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Marcy Sullivan marcy.sullivan@usoncology.com | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 16, 2019 | ||||
| Last Update Posted Date | September 11, 2020 | ||||
| Actual Study Start Date ICMJE | July 18, 2019 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens | ||||
| Official Title ICMJE | A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors | ||||
| Brief Summary | The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors. | ||||
| Detailed Description | 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. Some of these tumor-specific neoantigens are known or expected to be common across a subset of patients and are called shared neoantigens. This study aims to target shared neoantigens using a heterologous prime/boost therapeutic vaccine approach (GRT-C903 first followed by GRT-R904) in combination with checkpoint blockade to stimulate an immune response. This study will explore the safety and early clinical activity of this neoantigen-based immunotherapy intended to induce T-cell responses specific for the shared neoantigens contained within the therapeutic vaccine. Phase 1 will test multiple doses and combinations with checkpoint blockade and Phase 2 will test for early signs of clinical activity using a vaccine regimen based on Phase 1 data. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 Phase 2 |
||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
144 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2023 | ||||
| Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
BRAF_G466V // CTNNB1_S37F // CTNNB1_S45F // CTNNB1_S45P // CTNNB1_T41A // ERBB2_Y772_A775dup // KRAS_G12C or NRAS_G12C // KRAS_G12D or NRAS_G12D // KRAS_G12V // KRAS_G13D // KRAS_Q61H or NRAS_Q61H // KRAS_Q61K or NRAS_Q61K // KRAS_Q61L or NRAS_Q61L // KRAS_Q61R or NRAS_Q61R // TP53_K132E // TP53_K132N // TP53_R213L // TP53_R249M // TP53_S127Y
Exclusion Criteria:
Complete inclusion and exclusion criteria are listed in the clinical study protocol. |
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03953235 | ||||
| Other Study ID Numbers ICMJE | GO-005 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Gritstone Oncology, Inc. | ||||
| Study Sponsor ICMJE | Gritstone Oncology, Inc. | ||||
| Collaborators ICMJE | Bristol-Myers Squibb | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Gritstone Oncology, Inc. | ||||
| Verification Date | September 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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