Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma (NCT03969004)
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 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 (166 Sites)
Showing the first 25 of 166 sites.
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Mayo Clinic Hospital — Phoenix, Arizona
- Regeneron Study Site — Tucson, Arizona
- The Angeles Clinic — Los Angeles, California
- University of Southern California (USC) — Los Angeles, California
- Stanford Cancer Institute, Stanford Medicine at Stanford University — Palo Alto, California
- University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center — San Francisco, California
- George Washington University School of Medicine and Health Sciences — Washington D.C., District of Columbia
- University of Florida Health — Gainesville, Florida
- Sylvester Comprehensive Cancer Center — Miami, Florida
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida
- University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
- Regeneron Study Site — Atlanta, Georgia
- Regeneron Study Site — Chicago, Illinois
- Regeneron Study Site — Louisville, Kentucky
- Regeneron Study Site — Baltimore, Maryland
- Massachusetts General Cancer Center — Boston, Massachusetts
- Dana Farber/Harvard Cancer Center — Boston, Massachusetts
- Michigan Medicine- University of Michigan — Ann Arbor, Michigan
- University of Missouri Health Care - University Physicians - Medicine Specialty Clinic — Columbia, Missouri
- Washington University in Saint Louis — St Louis, Missouri
- Nebraska Methodist Hospital — Omaha, Nebraska
- Memorial Sloan Kettering — Basking Ridge, New Jersey
- Memorial Sloan Kettering — Middletown, New Jersey
- Memorial Sloan Kettering — Montvale, New Jersey
📞 Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 Cutaneous Squamous Cell Carcinoma
- Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer — La Jolla, California
- A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma — Albury, New South Wales
- A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer — Aurora, Colorado
- Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma — Houston, Texas
- Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy — Boston, Massachusetts
Explore by condition: All Cutaneous Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.