Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02959463
Phase
PHASE1
Status
Completed

Conditions

  • Pleural Malignant Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Palliative Radiation Therapy — RADIATION
    Undergo palliative radiation therapy
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Undergo hemithoracic radiation therapy

Study Details

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.

Key Dates

Start date
May 1, 2017
Status verified
May 2026
Primary completion
Nov 15, 2024
Completion
Apr 27, 2026

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (hemithoracic radiation therapy, pembrolizumab)
    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.
  • Experimental: Cohort 2 (palliative radiation therapy, pembrolizumab)
    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.

Primary Outcome Measure

Safety/Toxicity [ Time Frame: Baseline to 4-months after the start of radiation therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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M D Anderson Cancer Center· Houston, TX