Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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 (applicable for dose escalation and non-randomized dose expansion cohorts)
- documented relapse or progression on or after the most recent line of therapy
- no standard therapy options
- Adequate organ and bone marrow function as defined in the protocol
- Life expectancy of at least 3 months
- Randomized phase 2 expansion cohorts only: Platinum resistant ovarian cancer patients who have had 1 to 4 lines of platinum-based therapy and prior treatment with a poly ADP-ribose polymerase (PARP) inhibitor or bevacizumab as defined in the protocol.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy
- Expansion cohort only: More than 4 prior lines of cytotoxic chemotherapy
- 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 and/or current cardiac findings as defined in the protocol
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Recurrent Ovarian Cancer,Recurrent Fallopian Tube Cancer,Recurrent Primary Peritoneal Cancer
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
554
Est. Completion Date
Jul 24, 2024
Treatment type
Interventional
Sponsor
Regeneron Pharmaceuticals
ClinicalTrials.gov identifier
NCT03564340
Study number
R4018-ONC-1721
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?