A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab (NCT04590326) — Belgium Trial Details

Condition(s) studied

Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerEndometrial Cancer

Investigational drug(s) / intervention(s)

REGN5668Cemiplimab →Ubamatamab →Sarilumab →Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] →

REGN5668: Administer per the protocol

Cemiplimab: Administer per the protocol

Ubamatamab: Administer per the protocol

Sarilumab: Administer per the protocol

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]: Administer per the protocol

Study summary

This study is researching an investigational drug called REGN5668 :

* alone or,
* combined with cemiplimab (also known as REGN2810) or,
* combined with both cemiplimab and fianlimab (also known as REGN3767), or
* combined with ubamatamab (also known as REGN4018), with or without sarilumab.

The main purposes of this study are to:

* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus
* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus

This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.

The study is looking at several other research questions, including:

* Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
* How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood
* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

No

Key Inclusion Criteria: 1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol 2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol. 3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts) 4. Has adequate organ and bone marrow function as defined in the protocol 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has a life expectancy of at least 3 months 7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol Key Exclusion Criteria: 1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy 2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol 3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy 4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy 5. Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug 6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol 7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol 8. Has history of clinically significant cardiovascular disease as defined in the protocol 9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s). Note: Other protocol-defined Inclusion/Exclusion criteria apply

Primary outcome measure(s)

Incidence of Dose Limiting Toxicities (DLT) — 42 days
Dose escalation phase, Module 1
Incidence of DLTs — 21 days post combination administration
Dose escalation phase, Module 2
Incidence of Treatment-Emergent Adverse Events (TEAEs) — Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Incidence of Serious Adverse Events (SAEs) — Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Incidence of deaths — Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0]) — Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab — Through study completion, up to 5 years
Primary: Dose escalation phase
Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination) — Through study completion, up to 5 years
Primary: Dose expansion phase

Trial sites (28)

Facility	City	Region	Status
City of Hope Comprehensive Cancer Center	Duarte	California	Recruiting
The City of Hope Orange County Lennar Foundation Cancer Center	Irvine	California	Recruiting
Chao Family Comprehensive Cancer Center	Orange	California	Recruiting
H. Lee Moffitt Cancer Center	Tampa	Florida	Completed
Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago	Illinois	Recruiting
University of Chicago Medical Center	Chicago	Illinois	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Dana Farber Cancer Institute Brookline Avenue	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	Recruiting
Perelman School of Medicine at the University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Seattle Cancer Care Alliance at South Lake Union - G3630	Seattle	Washington	Recruiting
Universitair Ziekenhuis Leuven	Leuven	Vlaams-Brabant	Recruiting
Centro de Pesquisa em Oncologia PUCRS	Porto Alegre	Rio Grande do Sul	Recruiting
Fundacao Pio XII - Hospital de Cancer de Barretos	Barretos	São Paulo	Recruiting
Unimed Sorocaba	Sorocaba	São Paulo	Recruiting
AC Camargo Cancer Center, Fundacao Antonio Prudente	São Paulo	Brazil	Recruiting
Hopital Lyon Sud	Pierre-Bénite	Auvergne-Rhône	Recruiting
Centre Georges Francois Leclerc	Dijon	Bourgogne-Franche-Comté	Recruiting
Institut Bergonie	Bordeaux	New Aquitaine	Recruiting
Centre Francois Baclesse (CFB)	Caen	Normandy	Recruiting
Institut Gustave Roussy	Villejuif	France	Recruiting
Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela	A Coruna	Recruiting
Institut Catala dOncologia Girona	Girona	Spain	Recruiting
Ciudad Universitaria	Madrid	Spain	Recruiting
Hospital Universitario Fundacion Jimenez	Madrid	Spain	Recruiting
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM	Madrid	Spain	Recruiting

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