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

INTRODUCTION

  • Org Study ID: GO-004
  • Secondary ID: N/A
  • NTC ID: NCT03639714
  • Sponsor: Gritstone Oncology, Inc.

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.

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.

  • Overall Status
    Recruiting
  • Start Date
    February 13, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: 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 - Timeframe: 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 - Timeframe: Up to approximately 6 months

CONDITION

  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • Gastroesophageal Adenocarcinoma
  • Urothelial Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 857-327-9816

Email: aferguson@gritstone.com

LOCATION

Facility Status Contact
Facility: Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Grace Ma
480-342-6925
Ma.Grace@mayo.edu
Facility: Mayo Clinic
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Andrea Georgiou
855-776-0015
Georgiou.Andrea@mayo.edu
Facility: The University of Chicago
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Aurelie Desgardin
646-888-4327
adesgard@medicine.bsd.uchicago.edu
Facility: Mayo Clinic
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office

MAYOCLINICCANCERSTUDIES@mayo.edu
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10017
United States
Status: Recruiting Contact: Contact
Amin Yaqubie

yaqubiea@mskcc.org
Facility: Columbia University Medical Center
New York, New York 10032
United States
Status: Recruiting Contact: Contact
Michael Comiskey

mc4375@cumc.columbia.edu
Facility: The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Carly Pilcher

carly.pilcher@osumc.edu
Facility: Tennessee Oncology
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Dee McComb

davinia.mccomb@sarahcannon.com
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Mari Gray

migray@mdanderson.org
Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Marcy Sullivan

marcy.sullivan@usoncology.com
Facility: Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Status: Recruiting Contact: N/A