Phase 2 Prostate Cancer Trial, Recruiting NCT03972657 Sponsor: Regeneron Pharmaceuticals Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT03972657
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For men with advanced prostate cancer (mCRPC):

  • Men who have been diagnosed with a specific type of prostate cancer (adenocarcinoma) confirmed by lab testing, but not the pure small cell type.
  • Men whose PSA level is at least 4 ng/mL at the screening visit and has been rising in the 6 months before screening.
  • Men who have already received at least 2 previous approved treatments for their prostate cancer (beyond hormone-blocking therapy), including at least one newer anti-hormone drug (such as abiraterone, enzalutamide, apalutamide, or darolutamide) AND a specific type of radiation therapy targeting PSMA (such as 177Lu-PSMA-617).

For men and women with advanced kidney cancer (ccRCC):

  • People who have been diagnosed with a specific type of kidney cancer called clear-cell renal cell carcinoma, confirmed by lab testing.
  • People whose kidney cancer has spread to other parts of the body and has at least one measurable tumour spot on scans.
  • People who have already received at least one approved treatment for their advanced kidney cancer, which must have included an immunotherapy drug targeting PD-1 or PD-L1, and either ipilimumab or a targeted therapy drug called a tyrosine kinase inhibitor.

Who may not be able to join:

  • People who received an approved cancer treatment within 3 weeks before the first study dose, or who are still experiencing side effects from a previous treatment.
  • People who received a biological cancer therapy within a certain time window before the first study dose (confirm specific timing with trial site).
  • People who have previously received any therapy that targets PSMA — except for a PSMA-targeted radiation treatment (such as 177Lu-PSMA-617) in the prostate cancer group.
  • People in the dose escalation phase who have had prior immunotherapy cancer treatment (other than a specific vaccine called sipuleucel-T) within a certain time before the study.
  • People in the dose expansion phase (prostate cancer group only) who have had any prior immunotherapy cancer treatment.
  • People who need ongoing daily use of corticosteroid medicines above a certain dose (more than 10 mg of prednisone per day or an equivalent anti-inflammatory drug) within 1 week before the first study dose.
  • People who have had a significant autoimmune disease in the past 5 years that required treatment with medicines that suppress the immune system.
  • People who have had brain inflammation (encephalitis), meningitis, a progressive neurological disease (except mild memory problems that do not affect daily life), or poorly controlled seizures in the year before the first study dose.
  • People with an uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed immune system deficiency.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
12 August 2019
Est. completion
15 November 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs); Incidence and severity of Adverse Event of Special Interests (AESIs); Incidence and severity of Serious Adverse Events (SAEs); Number of participants with Grade ≥3 laboratory abnormalities; Incidence of Dose-Limiting Toxicities (DLTs); Concentration of REGN5678 in serum over time; Concentration of REGN5678 in combination with cemiplimab in serum over time; Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR); Objective...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov