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.
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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | February 13, 2019 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Primary Outcome 1 - Time Frame: Initiation of study treatment through 100 days post-last dose (up to approximately 27 months)
Primary Outcome 2 - Measure: Objective Response Rate (ORR) in Phase 2 using RECIST v1.1
Primary Outcome 2 - Time Frame: Initiation of study treatment until disease progression (up to approximately 27 months)
Primary Outcome 3 - Measure: Identify the recommended Phase 2 dose (RP2D) of GRT-C901 and GRT-R902
Primary Outcome 3 - Time Frame: Up to approximately 6 months
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
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 MSI disease
3. 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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Andy Ferguson
Phone: 857-327-9816
Email: aferguson@gritstone.com
Facility | Status | Contact |
---|---|---|
Mayo Clinic Arizona Phoenix, Arizona 85054 United States |
Recruiting |
Grace Ma 480-342-6925 Ma.Grace@mayo.edu |
Mayo Clinic Jacksonville, Florida 32224 United States |
Recruiting |
Andrea Georgiou Georgiou.Andrea@mayo.edu |
The University of Chicago Chicago, Illinois 60637 United States |
Recruiting |
Aurelie Desgardin adesgard@medicine.bsd.uchicago.edu |
Mayo Clinic Rochester, Minnesota 55905 United States |
Recruiting |
Clinical Trials Referral Office 855-776-0015 MAYOCLINICCANCERSTUDIES@mayo.edu |
Columbia University Medical Center New York, New York 10032 United States |
Recruiting |
Michael Comiskey mc4375@cumc.columbia.edu |
The Ohio State University Comprehensive Cancer Center Columbus, Ohio 43210 United States |
Recruiting |
Carly Pilcher carly.pilcher@osumc.edu |
Tennessee Oncology Nashville, Tennessee 37203 United States |
Recruiting |
Dee McComb davinia.mccomb@sarahcannon.com |
MD Anderson Cancer Center Houston, Texas 77030 United States |
Recruiting |
Mari Gray migray@mdanderson.org |
Virginia Cancer Specialists Fairfax, Virginia 22031 United States |
Recruiting |
Marcy Sullivan marcy.sullivan@usoncology.com |