Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma (NCT04671667)
A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. 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 alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years to 79 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (178 Sites)
Showing the first 25 of 178 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Kaiser Permanente-Anaheim — Anaheim, California
- Kaiser Permanente-Bellflower — Bellflower, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- Kaiser Permanente-Ontario — Ontario, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California
- Sutter Roseville Medical Center — Roseville, California
- California Protons Cancer Therapy Center — San Diego, California
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut
- Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
- Moffitt Cancer Center-International Plaza — Tampa, Florida
- Moffitt Cancer Center - McKinley Campus — Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Recurrent Head and Neck Squamous Cell Carcinoma
- An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors — Miami, Florida
- Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma — St Louis, Missouri
- A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases — Duarte, California
Explore by condition: All Recurrent Head and Neck Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.