Pembrolizumab, Capecitabine, and Bevacizumab for Treating Colorectal Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03396926
Phase
PHASE2
Status
Completed

Conditions

  • Microsatellite Stable
  • Mismatch Repair Protein Proficient
  • Stage III Colorectal Cancer AJCC v7
  • Stage IIIB Colorectal Cancer AJCC v7
  • Stage IIIC Colorectal Cancer AJCC v7
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given intravenously (IV)
  • Capecitabine — DRUG
    Given orally (PO)
  • Specimen collection — PROCEDURE
    For use in correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies the side effects and best dose of capecitabine when given together with pembrolizumab and bevacizumab, and investigates how well they work in treating patients with microsatellite stable colorectal cancer that has spread to nearby tissues or lymph nodes, has spread to other places in the body, or that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine together with pembrolizumab and bevacizumab may work better in treating patients with colorectal cancer.

Key Dates

Start date
Apr 18, 2018
Status verified
Feb 2025
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024

Study Design

Enrollment
44 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead in Cohort: Treatment (pembrolizumab, bevacizumab, capecitabine)
    Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Expansion Cohort: Treatment (pembrolizumab, bevacizumab, capecitabine)
    Participants receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of Participants With Treatment-related, Dose-limiting Toxicities (DLT) (Safety Lead-In Cohort) [ Time Frame: Up to 1 cycle (each cycle is 21 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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