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NCT03304639 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma
A Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 20
- Study locations
NCT03304639: Active Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT03304639 is a Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants, below the 37-participant average among 4 other Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03304639, a Phase 2 study of Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- RADIATION Stereotactic Body Radiation Therapy
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Colorado
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- AdventHealth Porter - Denver
- Saint Anthony Hospital - Lakewood
- AdventHealth Littleton - Littleton
- Longmont United Hospital - Longmont
- AdventHealth Parker - Parker
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
California
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2026-09-19 |
| Phase | Phase 2 |
What the registry record for NCT03304639 still lists
NCT03304639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 37-participant average among 4 other Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 trials with a reported enrollment target (76% lower).
The record links to 8 conditions, with Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03304639 names 20 study sites across 5 states, led by Alaska, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT03304639 about?
NCT03304639 is a clinical study titled "Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma". 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 b...
What is the current status of trial NCT03304639?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2018-06-12. Estimated completion is 2026-09-19.
What conditions does trial NCT03304639 study?
This clinical trial studies the following conditions: Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Merkel Cell Carcinoma, Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Advanced Merkel Cell Carcinoma.
What interventions are being tested in trial NCT03304639?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Stereotactic Body Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03304639?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03304639 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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