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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510783-23-00 | EU Trial (CTIS) Number | ||
| 2019-003298-24 | EudraCT Number |
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The main purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | REGN4018 administration |
|
| Combination Therapy | Experimental | REGN4018 and cemiplimab administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubamatamab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy | Dose Escalation Phase | From Cycle 1, Day 1 up to 35 days |
| Number of participants with DLTs for ubamatamab with cemiplimab | Dose Escalation Phase | From Cycle 2, Day 1 up to 21 days |
| Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy | Dose Escalation Phase | Up to 2 years |
| Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab | Dose Escalation Phase | Up to 2 years |
| Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy | Dose Escalation Phase | Up to 2 years |
| Number of participants with SAEs for ubamatamab with cemiplimab | Dose Escalation Phase | Up to 2 years |
| Number of deaths for ubamatamab monotherapy | Dose Escalation Phase | Up to 2 years |
| Number of deaths for ubamatamab with cemiplimab | Dose Escalation Phase |
| Measure | Description | Time Frame |
|---|---|---|
| ORR based on RECIST 1.1 for ubamatamab monotherapy | Dose Escalation Phase | Up to 2 years |
| ORR based on RECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation Phase |
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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:
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 2 to 4 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:
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 |
|---|---|---|---|---|---|---|
| University of Alabama_6th Ave | Recruiting | Birmingham | Alabama | 35294 | 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 | Administered per the protocol |
|
|
| Sarilumab | Drug | Administered per the protocol |
|
|
| Tocilizumab | Drug | Administered per the protocol |
|
|
| Up to 2 years |
| Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy | Dose Escalation Phase | Up to 2 years |
| Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab | Dose Escalation Phase | Up to 2 years |
| Concentration of ubamatamab in serum over time for ubamatamab monotherapy | Dose Escalation Phase | Up to 2 years |
| Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab | Dose Escalation Phase | Up to 2 years |
| Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| ORR defined by RECIST 1.1 for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Up to 2 years |
| Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Number of participants with SAEs for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Number of participants with SAEs for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Number of deaths for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Number of deaths for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Concentration of ubamatamab in serum over time for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab monotherapy | Dose Expansion Phase The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." | Baseline up to 2 years |
| Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab with cemiplimab | Dose Expansion Phase | Baseline up to 2 years |
| Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab monotherapy | Dose Expansion Phase | Baseline up to 2 years |
| Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab with cemiplimab | Dose Expansion Phase | Baseline up to 2 years |
| Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for ubamatamab monotherapy | Dose Expansion Phase excluding the Endometrial Cancer Cohort The MOST-24 is a 24-item questionnaire used to measure the impact of chemotherapy on symptoms (21 items) and well-being (3 items). The expected questionnaire completion time is less than 5 minutes. The prevalence of each MOST item at assessment time points can be summarized by providing the mean, standard deviation and proportions based on the MOST response format, a numeric rating scale with integers from zero to 10, with five verbal anchors: 'No trouble at all' (0), 'Mild' (1-3), 'Moderate' (4-6), 'Severe' (7-10), and 'Worst I can imagine' (10). | Baseline up to 2 years |
| Change from baseline in abdominal symptoms as measured by the MOST-Abdominal index score for ubamatamab with cemiplimab | Dose Expansion Phase Not applicable to Endometrial Cancer Cohort | Baseline up to 2 years |
| Time to deterioration in GHS/QoL for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Time to deterioration in GHS/QoL for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Time to deterioration in physical functioning for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Time to deterioration in physical functioning for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Time to deterioration in abdominal symptoms for ubamatamab monotherapy | Dose Expansion Phase | Up to 2 years |
| Time to deterioration in abdominal symptoms for ubamatamab with cemiplimab | Dose Expansion Phase | Up to 2 years |
| Change from baseline in QoL as measured by EQ-5D for ubamatamab monotherapy | Dose Expansion Phase | Baseline up to 2 years |
| Change from baseline in QoL as measured by EQ-5D for ubamatamab with cemiplimab | Dose Expansion Phase | Baseline up to 2 years |
| ORR based on iRECIST for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| ORR based on iRECIST for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Best overall response (BOR) based on RECIST 1.1 for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| BOR based on iRECIST for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| BOR based on RECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| BOR based on iRECIST for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Duration of response (DOR) based on RECIST 1.1 for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| DOR based on iRECIST for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| DOR based on RECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| DOR based on iRECIST for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Disease control rate based on RECIST 1.1 for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Disease control rate based on iRECIST for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Disease control rate based on RECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Disease control rate based on iRECIST for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Complete response (CR) rate based on RECIST 1.1 for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| CR rate based on iRECIST 1.1 for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| CR rate based on RECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| CR rate based on iRECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Progression-free survival (PFS) based on RECIST 1.1 for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| PFS based on iRECIST for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| PFS based on RECIST 1.1 for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| PFS based on iRECIST for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Cancer antigen-125 (CA-125) response for ubamatamab monotherapy | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| CA-125 response for ubamatamab with cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Presence or absence of anti-drug antibodies against ubamatamab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Presence or absence of anti-drug antibodies against cemiplimab | Dose Escalation and Dose Expansion Phases | Up to 2 years |
| Massachusetts General Hospital |
| Recruiting |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana Farber / Harvard Cancer Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55901 | United States |
| Roswell Park Cancer Institute | Withdrawn | Buffalo | New York | 14263 | United States |
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| The Ohio State University Wexner Medical Center James Comprehensive Cancer Center | Recruiting | Hilliard | Ohio | 43026 | United States |
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23219 | United States |
| Prince of Wales Hospital | Completed | Randwick | New South Wales | 2031 | Australia |
| Peter MacCallum Cancer Center | Completed | Melbourne | 3000 | Australia |
| Universitair Ziekenhuis Antwerpen | Recruiting | Edegem | Antwerp | 2650 | Belgium |
| Grand Hopital de Charleroi | Recruiting | Charleroi | Hainaut | 6000 | Belgium |
| UZLeuven | 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 |
| Centre Antoine Lacassagne | Recruiting | Nice | Provence Alpes Cote dAzur | 06189 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | ÃŽle-de-France Region | 94800 | France |
| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
| Sharet Institute of Oncology | Recruiting | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Recruiting | Tel Litwinsky | 5265601 | Israel |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
| Humanitas S. Pio X | Recruiting | Milan | 20159 | Italy |
| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| Instituto Nazionale Tumori- Fondazione Pascale | Recruiting | Naples | 80131 | Italy |
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6500HB | Netherlands |
| Erasmus MC | Recruiting | Rotterdam | South Holland | 3000 DR | Netherlands |
| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center, Univ. of Ulsan | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 08307 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Institut Catala dOncologia Badalona | Recruiting | Badalona | 08916 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Institut Catala d'Oncologia | Recruiting | Barcelona | 8908 | Spain |
| Clinica Universidad Navarra (CUN) Madrid | Recruiting | Madrid | 28027 | Spain |
| Fundacion Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario San Carlos | Recruiting | Madrid | 28040 | Spain |
| Hospital Clinico Universitatio Santiago de Compostela | Recruiting | Santiago de Compostela | 15706 | Spain |
| University of Oxford | Recruiting | Oxford | Oxfordshire | OX1 2JD | United Kingdom |
| Royal Marsden Hospital - Sutton | Withdrawn | Sutton | Surrey | SM2 5PT | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
| University College London Hospitals | Recruiting | London | NW1 2PG | United Kingdom |
| Guys Hospital | Recruiting | London | SE1 9RT | United Kingdom |
| Imperial College Healthcare NHS Trust | Recruiting | London | W12 0HS | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| C000592401 | sarilumab |
| C502936 | tocilizumab |
| D059451 | Biosimilar Pharmaceuticals |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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