← Back to Search

Checkpoint Inhibitor

Radiation Therapy for Merkel Cell Carcinoma

Phase 3
Waitlist Available
Led By Janice Mehnert
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complete nodal dissection is not required for eligibility.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial compares pembrolizumab to observation in treating patients with resected Merkel cell cancer. Pembrolizumab is an immunotherapy that may help the body's immune system attack the cancer.

Eligible Conditions
  • Merkel Cell Carcinoma
  • Skin Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You do not need to have all lymph nodes removed to participate.

Timeline

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
OS
Recurrence free survival (RFS)
Secondary outcome measures
Impact of radiation therapy on OS
Impact of radiation therapy on RFS
Impact of radiation therapy on distant metastasis free survival (DMFS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (pembrolizumab, radiation therapy)Experimental Treatment6 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT, CT, or MRI throughout the trial. Patients may also undergo blood sample collection as clinically indicated at the discretion of the treating investigator.
Group II: Arm B (standard of care observation, radiation therapy)Active Control6 Interventions
Patients receive standard of care observation every 3 months for 1 year, and then every 6 months for 5 years. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT, CT, or MRI throughout the trial. Patients may also undergo blood sample collection as clinically indicated at the discretion of the treating investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Computed Tomography
2017
Completed Phase 2
~2790
Pembrolizumab
2017
Completed Phase 2
~1950
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Positron Emission Tomography
2008
Completed Phase 2
~2260
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,615 Previous Clinical Trials
40,918,417 Total Patients Enrolled
Janice MehnertPrincipal InvestigatorECOG-ACRIN Cancer Research Group
2 Previous Clinical Trials
55 Total Patients Enrolled
Brian R GastmanPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Frequently Asked Questions

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

What are the primary conditions that Pembrolizumab has been effective in treating?

"Pembrolizumab is a medication that can be used to treat people with malignant neoplasms. It can also be used to treat other conditions such as unresectable melanoma or disease progression after chemotherapy."

Answered by AI

Could you please provide some more information about other Pembrolizumab clinical trials?

"Pembrolizumab is being trialled in 1000 different studies, with 122 of them in Phase 3. The majority of these studies are being conducted in Houston, Texas, but there are 35962 locations running Pembrolizumab trials in total."

Answered by AI
~69 spots leftby Dec 2025