Study on Adding Radiation Therapy to Immunotherapy for Advanced Merkel Cell Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03304639

Provider View

This clinical trial is exploring whether combining radiation therapy with the immunotherapy drug pembrolizumab can improve treatment outcomes for patients with advanced Merkel cell cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing if using the immunotherapy drug pembrolizumab, with or without the addition of precise radiation therapy, can better treat advanced Merkel cell cancer that has spread. Pembrolizumab helps the immune system attack cancer cells, while stereotactic body radiation therapy (SBRT) targets tumors with high precision, potentially reducing side effects. The trial aims to see if combining these treatments is more effective than using pembrolizumab alone.

Description

The main goal of this study is to compare how well patients with advanced Merkel cell carcinoma (MCC) do when treated with pembrolizumab alone versus pembrolizumab combined with stereotactic body radiation therapy (SBRT). Researchers want to see if the combination helps patients live longer without the cancer getting worse.

Secondary goals include:

  • Comparing the overall response rates of the two treatments.
  • Checking the safety and side effects of the treatments.
  • Evaluating how well the radiation therapy controls the tumors.

Patients in the study will be randomly assigned to one of two groups:

  • Group 1 will receive pembrolizumab every 21 days for up to 2 years, as long as the cancer does not progress or cause unacceptable side effects.
  • Group 2 will receive the same pembrolizumab treatment, plus three doses of SBRT during the first cycle.

After finishing the treatment, patients will have follow-up visits every 6 months for up to 5 years to monitor their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Merkel cell carcinoma (MCC).
  • Must have advanced or metastatic MCC, meaning the cancer has spread to distant parts of the body.
  • Must have at least two cancerous areas, with one suitable for radiation therapy.
  • No previous immunotherapy for advanced MCC.
  • No untreated or uncontrolled brain metastases, but controlled brain metastases are allowed.
  • Must not have received radiation therapy to the area planned for SBRT.
  • Must not have autoimmune diseases requiring treatment in the past 2 years.
  • HIV-positive patients can participate if their CD4 count is 350 or higher and their viral load is below 25,000 IU/ml.
  • Must not have other active cancers that could interfere with the study.
  • Women must not be pregnant or nursing and must have a negative pregnancy test before joining the study.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must meet specific blood count and organ function criteria.
  • Must have imaging tests to confirm cancer spread within 45 days before joining the study.

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