Pembrolizumab for Small Intestinal Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byRobert McWilliams

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Academic and Community Cancer Research United

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab works in treating patients with small bowel adenocarcinoma that has spread to other places in the body or that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Research Team

Robert McWilliams

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

This trial is for patients with small bowel adenocarcinoma that has spread or can't be surgically removed. Participants must have had prior chemotherapy, adequate organ function, and no recent use of other investigational drugs. They should not have autoimmune diseases, active infections, or a history of certain cancers.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am not pregnant, will use birth control, or abstain from sex during and for 120 days after the study.

Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

See 7 more

Exclusion Criteria

My cancer started in the ampulla or appendix.

I have an immune system disorder or have been on steroids or immune-suppressing drugs in the last week.

I have recently used specific therapies or treatments.

See 15 more

Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe effectiveness of pembrolizumab, a monoclonal antibody designed to block cancer growth by interfering with tumor cells' ability to evade the immune system. This phase II trial will assess its impact on advanced small bowel adenocarcinoma.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.