Ovarian Cancer Clinical Trial
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
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
Eligibility Criteria
Key Inclusion Criteria:
Ovarian Cancer Cohorts Only: 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 ≥2 x 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 likely to convey clinical benefit
Adequate organ and bone marrow function as defined in the protocol
Life expectancy of at least 3 months
Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 1 to 3 lines of platinum-based therapy as defined in the protocol.
Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC)
1-2 prior lines of systemic therapy
Key Exclusion Criteria:
Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy
Prior treatment with a MUC16 - targeted therapy
Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
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
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There are 44 Locations for this study
Birmingham Alabama, 35294, United States
Boston Massachusetts, 02214, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Buffalo New York, 14263, United States
New York New York, 10032, United States
New York New York, 10065, United States
Hilliard Ohio, 43026, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Randwick New South Wales, NSW 2, Australia
Melbourne Victoria, 3000, Australia
Edegem Antwerp, 2650, Belgium
Charleroi Hainaut, 6000, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Dijon cedex Bourgogne, 21079, France
Nice Cedex 2, 06189, France
Pierre-Benite Lyon, 69310, France
Bordeaux , 33076, France
Caen cedex 5 , 14076, France
Villejuif Cedex , 94800, France
Haifa , 31096, Israel
Tel Hashomer , 52656, Israel
Roma Lazio, 00168, Italy
Milano , 20141, Italy
Naples , 80131, Italy
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 3080, Korea, Republic of
Seoul , 6351, Korea, Republic of
Nijmegen Gelderland, 6500H, Netherlands
Rotterdam Zuid Holland, 3000 , Netherlands
Groningen , 9713 , Netherlands
Pamplona Navarra, 31008, Spain
Madrid Navarre, 28027, Spain
Barcelona , 08035, Spain
Barcelona , 08916, Spain
Barcelona , 8908, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Santiago de Compostela , 15706, Spain
London England, NW1 2, United Kingdom
London England, SE1 9, United Kingdom
Manchester Greater Manchester, M20 4, United Kingdom
Sutton London, SM25P, United Kingdom
Oxford Oxfordshire, OX1 2, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
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