Brief Title
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult 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
Primary Objectives
In the Dose Escalation Phase:
• 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:
• 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
Secondary Objectives
In the Dose Escalation Phase:
• 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:
- To characterize the safety profile in each expansion cohort
- To characterize the PK of REGN4018 as monotherapy and in combination with cemiplimab.
- To assess the effects of REGN4018 as monotherapy and in combination with cemiplimab on
patient-reported outcomes (PROs), including health-related quality of life (HRQoL),
functioning, and symptoms
In both the Dose Escalation and Dose Expansion Phases:
- To assess preliminary efficacy of REGN4018 as monotherapy and in combination with
cemiplimab (separately by cohort) as measured by ORR based on 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.
- 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
554
Start Date
May 21, 2018
Completion Date
July 24, 2024
Primary Completion Date
July 24, 2024
Eligibility Criteria
Key Inclusion Criteria:
1. 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:
1. serum CA-125 level ≥2x upper limit of normal (ULN) (in screening)
2. has received at least 1 line of platinum-containing therapy or must be
platinum-intolerant (applicable for dose escalation and non-randomized dose
expansion cohorts)
3. documented relapse or progression on or after the most recent line of therapy
4. no standard therapy options
2. Adequate organ and bone marrow function as defined in the protocol
3. Life expectancy of at least 3 months
4. Randomized phase 2 expansion cohorts only: Platinum resistant ovarian cancer patients
who have only had 1 to 3 lines of platinum-based therapy prior treatment with poly
ADP-ribose polymerase (PARP) inhibitor or bevacizumab as defined in the protocol.
Key Exclusion Criteria:
1. Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy
2. Expansion cohort only: More than 4 prior lines of cytotoxic chemotherapy
3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or
spinal cord compression
5. History and/or current cardiac findings as defined in the protocol
6. Severe and/or uncontrolled hypertension at screening. Patients taking
anti-hypertensive medication must be on a stable anti-hypertensive regimen
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
Australia
Location Countries
Australia
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
February 2022