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, 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
366
Start Date
May 21, 2018
Completion Date
March 21, 2023
Primary Completion Date
May 11, 2022
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
United States
Location Countries
United States
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
March 2020