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
Recruiting · Phase 1, Phase 2 · NCT03972657
Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
At a glance
- Research payments reported, 2025
- $4.2M
- U.S. investigators named
- 20
- Sites paid
- 18
- Planned or actual enrollment
- 345
About the trial
- Sponsor
- Regeneron Pharmaceuticals
- Tested
- REGN5678 (drug), Cemiplimab (drug)
- Dates
- Started 2019-08-12; completion 2027-11-15
- Results posted
- Not yet
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 alon…
From ClinicalTrials.gov, last updated 2026-11-04. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $4.2M in research payments for this study in 2025 (543 payments).
Products named: Libtayo
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Cassandra N. Moore, M.D. Hematology & Oncology · Scottsdale, AZ
- Przemyslaw Twardowski, MD Medical Oncology · Santa Monica, CA
- Gerald S. Falchook, MD Medical Oncology · Denver, CO
- Joseph W. Kim, MD Medical Oncology · New Haven, CT
- Adam M. Kase, MD Hematology & Oncology · Jacksonville, FL
- Jingsong Zhang, M.D. Medical Oncology · Tampa, FL
- Xin Gao, M.D. Hematology & Oncology · Boston, MA
- Bilal A. Siddiqui, M.D. Internal Medicine · Boston, MA
- Lance C. Pagliaro, M.D. Medical Oncology · Rochester, MN
- Benjamin A. Gartrell, MD Internal Medicine · Bronx, NY
- Edward Gelmann Medical Oncology · New York, NY
- Eric J. Miller, MD Medical Oncology · New York, NY
- Deepak Sahasrabudhe, M.D. Hematology & Oncology · Rochester, NY
- Mark N. Stein, MD Medical Oncology · New York, NY
- Che-kai Tsao, M.D. Medical Oncology · New York, NY
- David R. Wise, M.D., PH.D. Medical Oncology · New York, NY
- Alexandra O. Sokolova, M.D. Hematology & Oncology · Portland, OR
- William K. Kelly, DO Medical Oncology · Philadelphia, PA
- Benedito A. Carneiro, MD Medical Oncology · Providence, RI
- Robert Dreicer, M.D. Medical Oncology · Charlottesville, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ut MD Anderson Cancer Center $1.6M
- The University of Arizona $523,021
- Moffitt Cancer Center $379,938
- Dana Farber Mass General Brigham Cancer Care Inc $276,694
- Yale University $263,641
- Sarah Cannon Research Institute LLC $183,712
- New York University School of Medicine $158,012
- Biomedical Research Alliance of New York LLC $152,257
- Trustees of Columbia University in The City of New York $130,775
- Rhode Island Hospital, RI $119,816
- University of Virginia Medical Center, VA $119,582
- Strong Memorial Hospital, NY $101,163
- Mayo Clinic Hospital, AZ $37,360
- Mayo Clinic $36,860
- Mount Sinai School of Medicine $36,636
- Mayo Clinic Jacksonville $29,860
- Saint Johns Cancer Institute $27,214
- Ohsu Hospital and Clinics, OR $15,081
- $3,987
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.