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
Sponsor: |
Regeneron Pharmaceuticals |
Enrolling: |
Male Patients Only |
IRB Number: |
AAAS3594 |
U.S. Govt. ID: |
NCT03972657 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA-approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain types of metastatic cutaneous squamous cell carcinoma (CSCC) (one of the main types of skin cancer) or locally advanced CSCC (who are not candidates for curative surgery or curative radiation). REGN5678 has not yet been studied in people.
Investigator
Mark Stein, MD
Are you male and at least 18 years of age? |
Yes |
No |
Do you have metastatic, castration-resistant prostate cancer (mCRPC)? |
Yes |
No |
Have you received at least 2 lines of therapy for mCRPC? |
Yes |
No |