A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors (NCT03972657)
A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression
🩺 Plain-English Summary (8th-Grade Level)
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor
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 (24 Sites)
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Mayo Clinic — Phoenix, Arizona
- University of Arizona — Tucson, Arizona
- John Wayne Cancer Institute (JWCI) — Santa Monica, California
- Sarah Cannon Research Institute (SCRI) — Denver, Colorado
- Yale University Hospital — New Haven, Connecticut
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Moffitt Cancer Center - McKinley Drive — Tampa, Florida
- Massachusetts General Hospital — Boston, Massachusetts
- Henry Ford Health — Detroit, Michigan
- Mayo Clinic — Rochester, Minnesota
- NYU Langone Health Perlmutter Cancer Center — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- Columbia University - The Trustees of Columbia University in the City of New York — New York, New York
- Montefiore Medical Center — New York, New York
- University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester — Rochester, New York
- James Cancer Hospital and Solove Research Institute — Columbus, Ohio
- Providence Portland Medical Center — Portland, Oregon
- Oregon Health & Science University (3485 S. Bond) — Portland, Oregon
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- Lifespan Cancer Institute — Providence, Rhode Island
- MD Anderson Cancer Center — Houston, Texas
- Emily Couric Clinical Cancer Center — Charlottesville, Virginia
- West Virginia University — Morgantown, West Virginia
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
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 Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer — Anchorage, Alaska
- Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer — Oklahoma City, Oklahoma
- PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA — Kelowna, British Columbia
- Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function — New York, New York
- Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T — Tuscon, Arizona
Explore by condition: All Metastatic Castration-Resistant Prostate Cancer (mCRPC) 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.