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A Study of a Personalized Neoantigen Cancer Vaccine

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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Gritstone Bio, Inc.

Study Description
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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

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. 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 Design
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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

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1
  • GRT-C901
  • GRT-R902
  • nivolumab
  • ipilimumab
 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
  • GRT-C901
  • GRT-R902
  • nivolumab
  • ipilimumab
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902 [ Time Frame: Up to approximately 6 months ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Duration of response (DOR) using RECIST v1.1 [ Time Frame: Initiation of study treatment until disease progression (up to approximately 4 years) ]
  4. Clinical benefit rate (using RECIST v1.1) [ Time Frame: Initiation of study treatment until disease progression (up to approximately 4 years) ]
  5. Progression-free survival (PFS) [ Time Frame: Up to approximately 4 years ]
  6. Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
  7. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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.


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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.

  • Patients with the indicated advanced or metastatic solid tumor as follows:

    1. 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)
    2. GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
    3. mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
    4. 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:

    1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
    2. For CRC and GEA, patients with known MSI-high disease based on institutional standard
    3. 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.

Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Gritstone Bio, Inc.
Bristol-Myers Squibb
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gritstone Bio, Inc.:
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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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