Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Gritstone bio, Inc.
Study ID
NCT05456165
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GRT-C901 — DRUG
    An individualized neoantigen cancer vaccine using an adenovirus vector administered via intramuscular (IM) injections at Visit 1 and boost at Visit 6.
  • GRT-R902 — DRUG
    An individualized neoantigen cancer vaccine using a self-amplifying mRNA (samRNA) vector administered via IM injection at Visits 2, 4, 9, and 12.
  • Atezolizumab — DRUG
    Dose of 1680 mg administered once every 4 weeks (Q4W) via intravenous (IV) infusion at Visits 1-13.
  • Ipilimumab — DRUG
    Dose of 30 mg administered via subcutaneous (SC) injection only with the first dose of GRT-C901 at Visit 1 and GRTR902 at Visit 2.
  • Adjuvant chemotherapy — DRUG
    Administered according to standard of care.

Study Details

The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus \[ChAd\] and self-amplifying messenger RNA \[samRNA\] vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic acid (ctDNA) following surgical resection.

Key Dates

Start date
May 19, 2022
Status verified
Dec 2024
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GRT-C901/GRT-R902 Vaccine arm
    After surgical resection, patients who are circulating tumor DNA (ctDNA) positive will receive adjuvant chemotherapy for 12-24 weeks during which they will undergo neoantigen prediction, randomization, and vaccine manufacturing. After study treatment screening, patients who are still ctDNA positive with no evidence of residual or metastatic disease will receive a total of 6 doses of GRT-C901/ GRT-R902, 2 doses of ipilimumab, and 13 doses of atezolizumab. Study visits occur every 28 days.
  • Active Comparator: Observation arm
    After surgical resection, patients who are ctDNA positive will receive adjuvant chemotherapy for 12-24 weeks during which they will undergo neoantigen prediction and randomization. After study treatment screening, patients who are still ctDNA positive with no evidence of residual or metastatic disease will be observed via study visits occur every 12 weeks.

Primary Outcome Measure

Percentage of Patients with a ≥50% Decrease from Baseline in Circulating Tumor deoxyribonucleic acid (ctDNA) [ Time Frame: Baseline and up to ~24 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
NYU Langone HealthNew YorkNew York10016-
Christ Hospital Cancer CenterCincinnatiOhio45229-

Find similar trials in Detroit, MI

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Barbara Ann Karmanos Cancer Institute· Detroit, MINYU Langone Health· New York, NYChrist Hospital Cancer Center· Cincinnati, OH

Related Studies