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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic procedure

Secondary outcome measures

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

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

~20

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,643 Total Patients Enrolled

93 Trials studying Mesothelioma

8,631 Patients Enrolled for Mesothelioma

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,778 Total Patients Enrolled

12 Trials studying Mesothelioma

604 Patients Enrolled for Mesothelioma

Daniel GomezPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

85 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02959463 — Phase 1

Mesothelioma Research Study Groups: Cohort 2 (palliative radiation therapy, pembrolizumab), Cohort 1 (hemithoracic radiation therapy, pembrolizumab)

Mesothelioma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT02959463 — Phase 1

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02959463 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for enrollees in this research endeavor?

"This medical trial has attained its desired amount of participants and is no longer recruiting. The initial post date was May 1st 2017, with the last update being on September 19th 2022. If you are searching for alternative studies, there are currently 1615 clinical trials actively looking for patients with malignant pleural mesothelioma and 963 Radiation Therapy trials that require volunteers."

Answered by AI

What maladies can be alleviated through the application of Radiation Therapy?

"High levels of radiation can be applied in order to treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Has Radiation Therapy been sanctioned by the FDA?

"The safety rating of this experimental Radiation Therapy is estimated to be 1, as it has only been tested with limited data confirming both its efficacy and risk profile."

Answered by AI

What is the participant capacity of this clinical trial?

"This medical trial is now closed for recruitment as the last edit was made on September 19th 2022. However, 1615 trials for malignant pleural mesothelioma and 963 Radiation Therapy studies are still actively enrolling patients."

Answered by AI

Has there been precedent for employing Radiation Therapy in medical trials?

"Presently, 963 clinical trials examining Radiation Therapy are ongoing with 122 of them in their Phase 3. 35772 medical centres around the world are running these studies and Houston, Texas is home to a significant number of them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma

2017. "Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02959463.

All > Lung Cancer Houston > Mesothelioma