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Protocol # 20-656

Status

Recruiting

Description

The primary objectives of the study in Dose Escalation are to evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab and in Dose Expansion are to assess efficacy, as measured by objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria, of REGN5678 in combination with cemiplimab. The secondary objectives of the study in Dose Escalation are to assess efficacy, as measured by ORR per modified PCWG3 criteria, of REGN5678 in combination with cemiplimab and in Dose Expansion are to characterize the safety profile in each expansion cohort and to characterize the PK of REGN5678 in combination with cemiplimab. Secondary objectives in both Dose Escalation and Dose Expansion are to assess efficacy of REGN5678 in combination with cemiplimab, as measured by additional criteria and to assess immunogenicity of REGN5678 in combination with cemiplimab. Note: All the above primary, secondary objectives will apply to each cohort in the study including those who receive sarilumab and those who do not receive sarilumab.

Condition

  • Metastatic Castration-resistant Prostate Cancer

Interventions

  • REGN5678
  • Cemiplimab
  • 18F-DCFPyL
  • Sarilumab

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • 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 patients 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
  • Objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria

Secondary Outcome:

  • ORR per modified PCWG3 criteria
  • Incidence and severity of TEAEs
  • Incidence and severity of AESIs
  • Incidence and severity of SAEs
  • Number of patients with grade ≥3 laboratory abnormalities
  • Concentration of REGN5678 in combination with cemiplimab in serum over time
  • ORR based upon prostate specific antigen (PSA) response
  • Percentage of patients with ≥90% decline of PSA
  • Percentage of patients who have achieved conversion of circulating tumor cell (CTC) count from baseline of ≥5 cells/7.5mL to <5 cells/7.5mL
  • Presence or absence of antibodies against REGN5678
  • Presence or absence of antibodies against cemiplimab

Enrollment

216

Study Start Date

August 12, 2019

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Regeneron Pharmaceuticals

Source

Regeneron Pharmaceuticals

Official title

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer

Clinicaltrials.gov Identifier

NCT03972657

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.