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Pembrolizumab + Radiation for Mesothelioma

Phase 1

Waitlist Available

Led By Daniel Gomez

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

COHORT 1: Patients must not have evidence of metastatic disease per positron emission tomography (PET)/ computed tomography (CT) scan; mediastinal lymph node involvement is acceptable

COHORT 1: Patients will have received at least 2 cycles of induction chemotherapy with pemetrexed/cisplatin or pemetrexed/carboplatin

Must not have

COHORTS 1 AND 2: Patients with inherited syndromes associated with hypersensitivity to ionizing radiation, specifically patients with known history of ataxia-telengiectasia, Nijmegen breakage syndrome

COHORT 1: Patients undergoing an extrapleural pneumonectomy (EPP); lung sparing surgeries, such as pleurectomy/decortication, are acceptable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing side effects and the best way to give pembrolizumab after radiation therapy for pleural malignant mesothelioma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pembrolizumab might cause immune-related side effects like inflammation in various organs (lungs, intestines), skin reactions, hormone gland problems (thyroid, pituitary), liver issues, infusion reactions and fatigue. Radiation could lead to skin changes at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have cancer spread beyond the mediastinal lymph nodes, confirmed by PET/CT scan.

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I have completed at least 2 cycles of chemotherapy with pemetrexed and either cisplatin or carboplatin.

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I have been diagnosed with mesothelioma from a tissue sample.

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

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I have been treated with platinum and pemetrexed for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am having or have had surgery to remove part or all of a lung due to cancer.

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I have been diagnosed with interstitial lung disease.

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I do not have immune system issues, active TB, allergies to pembrolizumab, or prior monoclonal antibody therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Overall survival assessed according to Response Evaluation Criteria for Solid Tumors version 1.1

Progression-free survival assessed according to Response Evaluation Criteria for Solid Tumors version 1.1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Palliative Radiation Therapy

2015

Completed Phase 1

~80