Pembrolizumab + Cryoablation for Mesothelioma

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byMichael Offin, 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 researchers are doing this study to find out whether the combination of pembrolizumab and cryoablation is a safe treatment that causes few or mild side effects in people with mesothelioma. The researchers will also look at whether the combination of pembrolizumab and cryoablation is effective against participants' cancer.

Eligibility Criteria

This trial is for adults with mesothelioma who've had at least one previous systemic therapy but not pembrolizumab as the most recent treatment. They must have a Karnofsky Performance Score of 70% or higher, adequate organ function, and agree to use effective contraception. Exclusions include those on continuous oxygen, certain medications like high-dose steroids, active infections like HIV/HBV/HCV, other progressing cancers, or severe allergies to pembrolizumab.

Inclusion Criteria

You have received at least one type of medicine that treats the whole body. If you have received immunotherapy before, it's okay as long as it didn't include pembrolizumab and wasn't the most recent treatment, unless it was given more than 1 year before joining the trial.

If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy

You have mesothelioma that has been confirmed by a specialized team of doctors who study tissues and cells.

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Exclusion Criteria

You need to use oxygen all the time.

You are currently receiving chemotherapy, immunotherapy, or biologic therapy for any condition. However, using hormones for non-cancer-related conditions, such as insulin for diabetes or hormone replacement therapy, is allowed.

You have experienced fast worsening of your condition after receiving immunotherapy, according to your doctor.

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Treatment Details

Interventions

Image-guided cryoablation (Procedure)
Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe study tests if combining pembrolizumab (an immunotherapy drug) with cryoablation (a procedure that freezes cancer cells) is safe and works against mesothelioma. Participants will receive both treatments and be monitored for side effects and effectiveness in fighting their cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: pembrolizumab followed by cryoablationExperimental Treatment2 Interventions

The treatment will consist of 1 cycle of pembrolizumab (200mg/flat dose) intravenously followed by cryoablation of an ablation index lesion 1-7 days prior to the start of cycle 2. Pembrolizumab will be continued for up to 24 months, until disease progression, or intolerable toxicity. Treatment beyond progression at discretion of the treating physician and Study PI. There will be a research biopsy within 1 week of cycle 5 start and an optional biopsy at end of treatment and/or progression of disease.

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

🇺🇸 Approved in United States as KEYTRUDA for: