Pembrolizumab + Radiation for Mesothelioma

Recruiting in Palo Alto (17 mi)

Daniel Gomez, MD, MBA - MSK Radiation ...

Overseen byMelenda Jeter, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best way to give pembrolizumab after radiation therapy in treating patients with pleural malignant mesothelioma. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after radiation therapy may kill more tumor cells.

Eligibility Criteria

This trial is for adults with pleural malignant mesothelioma who've had certain treatments. They must have acceptable blood and organ function, not be pregnant or breastfeeding, agree to use contraception, and have no severe medical conditions or recent live vaccines. Cohort 1 can't have metastatic disease outside the chest except lymph nodes; Cohort 2 can have any number of prior therapies.

Inclusion Criteria

I am not pregnant and agree to use birth control.

I have had any number of treatments before, including immunotherapy.

You need to have specific blood and chemical levels within a certain range.

+10 more

Exclusion Criteria

I have been treated with a drug targeting PD-1, PD-L1, or PD-L2 before.

I have a genetic condition like ataxia-telangiectasia or Nijmegen breakage syndrome.

I haven't had any infectious diseases or live vaccines in the last 30 days.

+9 more

Participant Groups

The study tests pembrolizumab's effectiveness when given after radiation therapy in mesothelioma patients. Pembrolizumab is an immunotherapy drug that may boost the immune system's cancer-fighting abilities post-radiation, which aims to shrink tumors by killing cancer cells.

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (palliative radiation therapy, pembrolizumab)Experimental Treatment3 Interventions

Patients undergo palliative radiation therapy over 1-3 weeks to only the region of palliation (a region that does not include the entire side of the chest or thorax). After radiation therapy, patients receive pembrolizumab IV over about 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Cohort 1 (hemithoracic radiation therapy, pembrolizumab)Experimental Treatment3 Interventions

Patients undergo hemithoracic radiation therapy. After radiation therapy, patients receive pembrolizumab IV over about 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for: