Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer

Brief Title

Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer

Official Title

A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer

Brief Summary

      The primary objectives of the Dose Escalation Phase are to assess the safety and
      pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended
      phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab. In the
      Dose Expansion Phase, the primary objectives are to assess the preliminary efficacy of
      REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as
      determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid
      Tumors (RECIST) 1.1.

      The secondary objectives of the Dose Escalation Phase are to assess the preliminary efficacy
      of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as
      determined by ORR by RECIST 1.1. In the Dose Expansion Phase, the secondary objectives are to
      characterize the safety profile in each expansion cohort and characterize the PK of REGN4018
      as monotherapy and in combination with cemiplimab. In both the Dose Escalation and Dose
      Expansion Phases, secondary objectives are to assess preliminary efficacy of REGN4018 as
      monotherapy and in combination with cemiplimab (separately by cohort) as measured by ORR
      based on immune based therapy RECIST (iRECIST), best overall response (BOR), duration of
      response (DOR), disease control rate, complete response (CR) rate and progression-free
      survival (PFS) based on RECIST 1.1 and iRECIST, to assess efficacy of REGN4018 as monotherapy
      and in combination with cemiplimab as measured by CA-125 level and immunogenicity of REGN4018
      and cemiplimab.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Number of participants with Dose-limiting toxicity (DLTs) for REGN4018 monotherapy

Secondary Outcome

 ORR based on RECIST 1.1 (Eisenhauer 2009) for REGN4018 monotherapy

Condition

Recurrent Ovarian Cancer

Intervention

REGN4018

Study Arms / Comparison Groups

 Monotherapy

Description:  REGN4018 administration

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 21, 2018

Completion Date

January 9, 2024

Primary Completion Date

March 1, 2023

Eligibility Criteria

        Key Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed diagnosis of advanced,
             epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian
             tube cancer who have all of the following:

          -  serum CA-125 level ≥2x upper limit of normal (ULN) (in screening)

          -  has received at least 1 line of platinum-containing therapy or must be
             platinum-intolerant

          -  documented relapse or progression on or after the most recent line of therapy

          -  no standard therapy options likely to convey clinical benefit

          -  Adequate organ and bone marrow function as defined in the protocol

          -  Adequately controlled blood pressure

          -  Life expectancy of at least 3 months

        Key Exclusion Criteria:

          -  Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy

          -  Expansion cohort only: More than 3 prior lines of cytotoxic chemotherapy for
             platinum-experienced and/or intolerant disease

          -  Expansion cohort only: prior treatment with a Mucin 16 (MUC16)-targeted therapy

          -  Untreated or active primary brain tumor, central nervous system (CNS) metastases, or
             spinal cord compression

          -  History of clinically significant cardiac disease, myocarditis, presence of moderate
             to large pericardial effusion and other measures of cardiac health as defined in the
             protocol

          -  Moderate to large pleural effusion as defined in the protocol

        Note: Other protocol Inclusion/Exclusion Criteria apply

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Trial Management, 844-734-6643, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT03564340

Organization ID

R4018-ONC-1721

Secondary IDs

2019-003298-24

Responsible Party

Sponsor

Study Sponsor

Regeneron Pharmaceuticals

Study Sponsor

Clinical Trial Management, Study Director, Regeneron Pharmaceuticals

Verification Date

January 2021