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

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

  Measured over: Through study completion, up to 5 years

• Incidence and severity of Adverse Event of Special Interests (AESIs)

  Measured over: Through study completion, up to 5 years

• Incidence and severity of Serious Adverse Events (SAEs)

  Measured over: Through study completion, up to 5 years

• Number of participants with Grade ≥3 laboratory abnormalities

  Measured over: Through study completion, up to 5 years

• Incidence of Dose-Limiting Toxicities (DLTs)

  Measured over: First dose through day 42 of last participant in each dose level

• Concentration of REGN5678 in serum over time

  Measured over: Through study completion, up to 5 years

• Concentration of REGN5678 in combination with cemiplimab in serum over time

  Measured over: Through study completion, up to 5 years

• Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)

  Measured over: Through study completion, up to 5 years

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

  Measured over: Through study completion, up to 5 years

Changes Tremor has spotted