Pembrolizumab for Lymphoma

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).

Eligibility Criteria

This trial is for adults with specific types of lymphoma (cHL or PMBCL) that have come back or didn't respond to treatment. They should be fairly healthy, able to perform daily activities with ease or only limited help, and not pregnant or breastfeeding. Participants need measurable disease, may have had certain prior treatments but not others like CAR-T therapy, and must not have serious heart issues or active infections.

Inclusion Criteria

- Is not a woman of child bearing potential (WOCBP). OR

My cancer can be measured on scans and has a large enough lesion that hasn't been treated with radiation.

I am using effective birth control or have been abstinent, and will continue for 120 days after the study ends.

See 12 more

Exclusion Criteria

You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.

I have received CAR-T cell therapy before.

I have had a serious heart condition or stroke in the last 6 months.

See 17 more

Treatment Details

Interventions

Pembrolizumab (PD-1 Inhibitor)

Trial OverviewThe study tests Pembrolizumab given every six weeks to see how well it works against two kinds of lymphoma. The main goal is to check the percentage of patients whose cancer shrinks or disappears after treatment as judged by a set standard called Lugano classification criteria.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Pembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: