Metastatic Castration-Resistant Prostate Cancer study: REGN5678 vs Cemiplimab
Official title 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
ClinicalTrials.gov ID: NCT03972657
What this study is testing
What is REGN5678 (Nezastomig)?
This is an investigational medicine being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as Nezastomig.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether REGN5678 (a new drug) alone or together with cemiplimab is safe and how well it works for people with advanced prostate or kidney cancer.
- Who it's for
- You may be able to join if you are an adult with metastatic castration‑resistant prostate cancer or clear cell kidney cancer.
- What's involved
- You will receive REGN5678 by itself or with cemiplimab, a medicine that helps the immune system. You will have regular doctor visits, blood tests, and scans to check your health and tumor size.
- Time commitment
- The study lasts several months with visits at the start, during treatment, and later check‑ins.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
- PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
- one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
- Histologically or cytologically confirmed RCC with a clear-cell component.
- Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
You likely can't join if
- Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute...
- Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
- Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
- Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
- Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
- Any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to...
See the full eligibility criteria
- Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
- PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
- one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
- Histologically or cytologically confirmed RCC with a clear-cell component.
- Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
- Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) [PD-1]/Programmed Death-Ligand 1 (PD-L1) therapy and...
- Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol
- Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
- Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
- Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
- Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
- Any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
- Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living [ADLs]) or uncontrolled seizures in the year prior to first dose of study...
- Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Rochester, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Morgantown, West Virginia, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Santa Monica, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.