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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517806-27-00 | Registry Identifier | EUCT Number |
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This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer.
The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin [PLD]), referred to as "combination drugs'.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1 | Experimental |
| |
| Arm A2 | Experimental |
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| Arm B | Experimental |
| |
| Arm C | Experimental |
| |
| Arm D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubamatamab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Antigen (CA) -125 response by Gynecologic Cancer Intergroup (GCIG) Criteria | Up to 3 years | |
| Complete Response (CR) rate by RECIST 1.1 | Up to 3 years | |
| Disease Control Rate (DCR) by RECIST 1.1 |
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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 |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | 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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| Bevacizumab | Drug | Administered per the protocol |
|
|
| Cemiplimab | Drug | Administered per the protocol |
|
|
| Fianlimab | Drug | Administered per the protocol |
|
|
| PLD | Drug | Administered per the protocol |
|
|
| Sarilumab | Drug | Administered per the protocol |
|
|
| Up to 3 years |
| Duration Of Response (DOR) by RECIST 1.1 | Up to 3 years |
| Progression-Free Survival (PFS) by RECIST 1.1 | Up to 3 years |
| Occurrence of Grade ≥ 2 Cytokine Release Syndrome (CRS) by Lee criteria | Up to 3 years |
| Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 3 years |
| TEAEs by Lee criteria | Up to 3 years |
| Concentration of ubamatamab in serum | Up to 3 years |
| Concentration of fianlimab in serum | Up to 3 years |
| Occurrence of Anti-Drug Antibodies (ADA) to ubamatamab | Up to 3 years |
| Magnitude of ADA to ubamatamab | Up to 3 years |
| Occurrence of ADA to fianlimab | Up to 3 years |
| Magnitude of ADA to fianlimab | Up to 3 years |
| Occurrence of ADA to cemiplimab | Up to 3 years |
| Magnitude of ADA to cemiplimab | Up to 3 years |
| UC San Diego Health |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| Mayo Clinic Jacksonville | Recruiting | Jacksonville | Florida | 32224 | United States |
| University of Miami Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
| Advent Health Cancer Institute | Recruiting | Orlando | Florida | 32804 | United States |
| Tampa General Hospital Cancer Institute | Recruiting | Tampa | Florida | 33606 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| The University of Kansas Cancer Center | Recruiting | Westwood | Kansas | 66205 | United States |
| Norton Cancer Institute, St. Matthews Clinic | Recruiting | Louisville | Kentucky | 40207 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| The Ohio State University Comprehensive Cancer Center | Recruiting | Hilliard | Ohio | 43026 | United States |
| Providence Cancer Institute | Recruiting | Portland | Oregon | 97213 | United States |
| University of Pittsburgh Medical Center, Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| West Penn Hospital of Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| Avera Cancer Institute Sioux Falls | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104 | United States |
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| CancerCare Manitoba | Recruiting | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Centre de Santé et de Services Sociaux de la Montérégie-Centre | Recruiting | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Research Institute - McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval | Recruiting | Québec | G1J 0J9 | Canada |
| National Cancer Center | Recruiting | Gyeonggi-do | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | Seoul | 21565 | South Korea |
| Keimyung University Dongsan Hospital | Recruiting | Daegu | 42601 | South Korea |
| Severance Hospital 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 |
| Gangnam Severance Hospital | Recruiting | Seoul | 135-720 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 8308 | South Korea |
| Changhua Christian Hospital | Recruiting | Changhua | Changhua City | 500 | Taiwan |
| Chi Mei Medical Center | Recruiting | Tainan | 71004 | Taiwan |
| Mackay Memorial Hospital | Recruiting | Taipei | 10449 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 106 | Taiwan |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11211 | Taiwan |
| Tri-Service General Hospital | Recruiting | Taipei | 114202 | Taiwan |
| Taipei Municipal Wan Fang Hospital | Recruiting | Taipei | 116 | Taiwan |
| Medicalpark Seyhan Hospital | Recruiting | Seyhan | Adana | 01140 | Turkey (Türkiye) |
| Hacettepe University | Recruiting | Altındağ | Ankara | 06240 | Turkey (Türkiye) |
| Medipol University Hospital | Recruiting | Istanbul | Bagcilar | 34284 | Turkey (Türkiye) |
| Gaziantep Medicalpoint Hospital | Recruiting | Gaziantep | Sehitkamil | 27584 | Turkey (Türkiye) |
| Baskent University | Recruiting | Adana | 01123 | Turkey (Türkiye) |
| Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Recruiting | Ankara | 06200 | Turkey (Türkiye) |
| Memorial Ankara Hospital | Recruiting | Ankara | 0906520 | Turkey (Türkiye) |
| Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa | Recruiting | Istanbul | 34450 | Turkey (Türkiye) |
| Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital) | Recruiting | Izmir | 35575 | Turkey (Türkiye) |
| Sakarya University - Education and Research Hospital | Recruiting | Sakarya | 54290 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube 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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000627974 | cemiplimab |
| C041277 | 1-dodecylpyridoxal |
| C506643 | liposomal doxorubicin |
| C000592401 | sarilumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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