Immunotherapy + Radiation for Cancer

Recruiting in Palo Alto (17 mi)

+293 other locations

Overseen byJason J Luke

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel cell cancer that has spread to other places in the body (advanced). 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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel cell cancer.

Eligibility Criteria

This trial is for adults with advanced Merkel Cell Carcinoma (MCC) who are in fairly good health, as shown by their ECOG status and normal organ function tests. They must have at least two cancerous deposits suitable for the study treatments and cannot be pregnant or nursing. People with HIV can join if they meet certain health criteria.

Inclusion Criteria

Your blood urea nitrogen level should be less than or equal to 30 mg/dl.

Your diastolic blood pressure is less than or equal to 90 mm Hg.

I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.

+16 more

Participant Groups

The trial is testing whether adding Stereotactic Body Radiation Therapy to Pembrolizumab, an immunotherapy drug, improves outcomes in patients with MCC. Participants will either receive just Pembrolizumab or both treatments together to see which works better.

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (pembrolizumab, SBRT)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

Group II: Group I (pembrolizumab)Active Control1 Intervention

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: