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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501904-83-00 | EU Trial (CTIS) Number |
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This study is researching an investigational drug called REGN5668 :
The main purposes of this study are to:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1 | Experimental | REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab |
|
| Module 2 | Experimental | REGN5668 and ubamatamab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5668 | Drug | Administer per the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLT) | Dose escalation phase, Module 1 | 42 days |
| Incidence of DLTs | Dose escalation phase, Module 2 | 21 days post combination administration |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Primary: Dose escalation phase Secondary: Dose expansion phase | Through study completion, up to 5 years |
| Incidence of Serious Adverse Events (SAEs) | Primary: Dose escalation phase Secondary: Dose expansion phase | Through study completion, up to 5 years |
| Incidence of deaths | Primary: Dose escalation phase Secondary: Dose expansion phase | Through study completion, up to 5 years |
| 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]) | Primary: Dose escalation phase Secondary: Dose expansion phase | Through study completion, up to 5 years |
| Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab | Primary: Dose escalation phase | Through study completion, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR based on RECIST 1.1 | Dose escalation phase | Through study completion, up to 5 years |
| Best Overall Response (BOR) based on RECIST 1.1 | Dose escalation and expansion phases |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Cemiplimab |
| Drug |
Administer per the protocol |
|
|
| Ubamatamab | Drug | Administer per the protocol |
|
|
| Sarilumab | Drug | Administer per the protocol |
|
|
| Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] | Drug | Administer per the protocol |
|
| 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) |
Primary: Dose expansion phase |
| Through study completion, up to 5 years |
| Through study completion, up to 5 years |
| Duration Of Response (DOR) based on RECIST 1.1 | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Disease Control Rate (DCR) based on RECIST 1.1 | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Progression-Free Survival (PFS) based on RECIST 1.1 | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Cancer Antigen 125 (CA-125) change from baseline after treatment with REGN5668 in combinations with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination) | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Concentration of REGN5668 in serum over time when dosed alone and in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Presence or absence of anti-drug antibodies against REGN5668 | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Presence or absence of anti-drug antibodies against ubamatamab | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Presence or absence of anti-drug antibodies against cemiplimab | Dose escalation and expansion phases | Through study completion, up to 5 years |
| Presence or absence of anti-drug antibodies against fianlimab | Dose escalation and expansion phases | Through study completion, up to 5 years |
| The City of Hope Orange County Lennar Foundation Cancer Center |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| Chao Family Comprehensive Cancer Center | Recruiting | Orange | California | 92868 | United States |
| H. Lee Moffitt Cancer Center | Completed | Tampa | Florida | 33612 | United States |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute Brookline Avenue | Recruiting | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| Perelman School of Medicine at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Seattle Cancer Care Alliance at South Lake Union - G3630 | Recruiting | Seattle | Washington | 98109 | United States |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Hopital Lyon Sud | Recruiting | Pierre-Bénite | Auvergne-Rhône | 69310 | France |
| Centre Georges Francois Leclerc | Recruiting | Dijon | Bourgogne-Franche-Comté | 21000 | France |
| Institut Bergonie | Recruiting | Bordeaux | New Aquitaine | 33076 | France |
| Centre Francois Baclesse (CFB) | Recruiting | Caen | Normandy | 14076 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Hospital Clinico Universitario Santiago de Compostela | Recruiting | Santiago de Compostela | A Coruna | 15706 | Spain |
| Institut Catala dOncologia Girona | Recruiting | Girona | 17007 | Spain |
| Ciudad Universitaria | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario Fundacion Jimenez | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM | Recruiting | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| C000592401 | sarilumab |
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