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BRIEF 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

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


  • Org Study ID: GO-004
  • Secondary ID:
  • NCT ID: NCT03639714
  • NCT Alias:
  • Sponsor: Gritstone Oncology, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting February 13, 2019 Phase 1/Phase 2 Interventional

Primary Outcomes:

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

Condition:

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

Eligibility

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

Overall Contact

Name: Andy Ferguson

Phone: 857-327-9816

Email: aferguson@gritstone.com

Locations

Facility Status Contact
The University of Chicago
Chicago, Illinois 60637
United States
Recruiting Aurelie Desgardin

adesgard@medicine.bsd.uchicago.edu
Columbia University Medical Center
New York, New York 10032
United States
Recruiting Michael Comiskey

mc4375@cumc.columbia.edu
Tennessee Oncology
Nashville, Tennessee 37203
United States
Recruiting Dee McComb

davinia.mccomb@sarahcannon.com
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Recruiting Claudia Phillips

claudia.phillips@usoncology.com