Pembrolizumab for Solid Cancers

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byYelena Janjigian, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the safety of the study drug, pembrolizumab, and to find out how well it works to prevent cancer from coming back in people who have had a solid tumor surgically removed, but still have tumor cells in their blood. During the study, the participant will receive either the study drug or a placebo for as long as 12 months, or until the cancer comes back, or the side effects of the treatment become too severe.

Eligibility Criteria

Adults who've had surgery to remove a solid tumor with high microsatellite instability (MSI-H) and still have cancer cells in their blood. They must have completed standard cancer treatments, be generally healthy with good organ function, and not be on immunosuppressive drugs. People can't join if they're pregnant, breastfeeding, or have active infections like TB or hepatitis.

Inclusion Criteria

Age 18 years or older

Albumin ≥3 mg/dL

Any solid tumor with MSI or MRD by IHC, PCR or NGS testing. MSKCC confirmation of MSI-H/MRD status is not mandatory prior to enrollment and treatment on the study. For patients with outside testing, if sufficient tissue is available NGS will be repeated at MSKCC and will not impact the patient's eligibility.

+13 more

Exclusion Criteria

Subjects with vitiligo or alopecia

Presence of metastatic or recurrent disease.

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.

+21 more

Participant Groups

The trial is testing pembrolizumab's effectiveness at preventing cancer recurrence after surgery compared to a placebo. Participants will receive the drug or placebo for up to 12 months unless the cancer returns or side effects become too severe.

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Pembrolizumab 200 mg IV every 3 weeks over 30 minutes.