24 Participants Needed

Pembrolizumab + Radiation for Mesothelioma

DG
MJ
Overseen ByMelenda Jeter, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
Must be taking: Platinum, Pemetrexed
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that patients should not receive steroids during pembrolizumab administration, and there are restrictions on recent chemotherapy, targeted therapy, or radiation therapy. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Pembrolizumab + Radiation for Mesothelioma?

Research shows that combining pembrolizumab (an immunotherapy drug) with radiotherapy can enhance the body's immune response against tumors, as seen in studies with other cancers like lung cancer. Additionally, advanced radiotherapy techniques have been effective in treating challenging cases of mesothelioma, providing a progression-free period without significant side effects.12345

Is the combination of Pembrolizumab and Radiation Therapy safe for humans?

Research on stereotactic radiotherapy (a precise form of radiation therapy) combined with immunotherapy (like Pembrolizumab) for brain metastases shows that the timing between treatments can affect safety, but it is generally used as a standard treatment. This suggests that while there may be some risks, the combination is considered safe enough to be used in clinical settings.678910

How is the treatment of Pembrolizumab combined with Radiation Therapy unique for mesothelioma?

This treatment is unique because it combines pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, with radiation therapy, which can enhance the immune response against tumors. This combination aims to improve the effectiveness of treatment for mesothelioma, a cancer with limited options after standard chemotherapy.14111213

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.

Research Team

MN

Matthew S. Ning

Principal Investigator

M.D. Anderson Cancer Center

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.
See 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.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo either hemithoracic or palliative radiation therapy

1-3 weeks

Treatment

Patients receive pembrolizumab IV every 3 weeks for up to 2 years

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Follow-up at 30 days, every 6 weeks for 48 weeks, then every 12 weeks

Treatment Details

Interventions

  • Palliative Radiation Therapy
  • Pembrolizumab
  • Radiation Therapy
Trial Overview 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.
Participant Groups
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:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇺🇸
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇯🇵
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇳
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇭
Approved in Switzerland as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 68 patients with advanced solid tumors, the combination of stereotactic body radiotherapy (SBRT) followed by pembrolizumab showed a high one-year treated metastasis control rate of 89.5%, indicating effective tumor response regardless of whether the tumors received complete or partial radiation coverage.
The study found that treated metastasis control (TMC) was significantly associated with improved overall survival, and SBRT altered tumor gene expression by increasing immune-related genes while decreasing those related to cell cycle and DNA repair, suggesting a mechanism for enhanced immune response.
Improved Survival Associated with Local Tumor Response Following Multisite Radiotherapy and Pembrolizumab: Secondary Analysis of a Phase I Trial.Luke, JJ., Onderdonk, BE., Bhave, SR., et al.[2021]
In a pooled analysis of 148 patients with metastatic non-small-cell lung cancer, adding radiotherapy to pembrolizumab significantly improved the best out-of-field response rate (41.7% vs 19.7%) and best disease control rate (65.3% vs 43.4%), indicating enhanced efficacy of the combination treatment.
Patients receiving the combination therapy also experienced longer median progression-free survival (9.0 months vs 4.4 months) and overall survival (19.2 months vs 8.7 months) compared to those receiving pembrolizumab alone, with no new safety concerns identified.
Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials.Theelen, WSME., Chen, D., Verma, V., et al.[2021]
In a phase I trial involving 38 patients with extensive-stage small cell lung cancer, the combination of pembrolizumab and thoracic radiotherapy was found to be safe, with no dose-limiting toxicities observed in the first 35 days of treatment.
The median progression-free survival was 6.1 months and overall survival was 8.4 months, suggesting that while the safety profile is promising, further studies are needed to fully understand the efficacy of this combined treatment approach.
Phase I Trial of Pembrolizumab and Radiation Therapy after Induction Chemotherapy for Extensive-Stage Small Cell Lung Cancer.Welsh, JW., Heymach, JV., Chen, D., et al.[2023]

References

Improved Survival Associated with Local Tumor Response Following Multisite Radiotherapy and Pembrolizumab: Secondary Analysis of a Phase I Trial. [2021]
Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials. [2021]
Phase I Trial of Pembrolizumab and Radiation Therapy after Induction Chemotherapy for Extensive-Stage Small Cell Lung Cancer. [2023]
Immune biomarkers of treatment failure for a patient on a phase I clinical trial of pembrolizumab plus radiotherapy. [2022]
Intensity-modulated radiotherapy for relapsed malignant pleural mesothelioma. [2020]
Adjuvant intensity-modulated proton therapy in malignant pleural mesothelioma. A comparison with intensity-modulated radiotherapy and a spot size variation assessment. [2021]
Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]
Toxicity and time lapse between immunotherapy and stereotactic radiotherapy of brain metastases. [2021]
Patient-reported outcomes after 3-dimensional conformal, intensity-modulated, or proton beam radiotherapy for localized prostate cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Commentary on "Patient-reported outcomes after 3-dimensional conformal, intensity-modulated, or proton beam radiotherapy for localized prostate cancer." Gray PJ, Paly JJ, Yeap BY, Sanda MG, Sandler HM, Michalski JM, Talcott JA, Coen JJ, Hamstra DA, Shipley WU, Hahn SM, Zietman AL, Bekelman JE, Efstathiou JA. Harvard Radiation Oncology Program, Boston, MA.: Cancer 2013;119(9):1729-35. doi: 10.1002/cncr.27956. [Epub 2013 Feb 22]. [2018]
Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
A Phase 1 Safety Study of Avelumab Plus Stereotactic Body Radiation Therapy in Malignant Pleural Mesothelioma. [2023]
Pembrolizumab-associated minimal change disease in a patient with malignant pleural mesothelioma. [2022]
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