Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Endometrial Cancer
Спонсор: Merck Sharp & Dohme LLC
Налично на:
БГ
Обобщение
Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.
Кой може да участва
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
* Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
* Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
Exclusion Criteria:
* Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \>12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
* Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
* Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
* Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
* Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
* Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization
Места на провеждане
28
Argentina (1)
Hospital Británico de Buenos Aires-Oncology ( Site 1002)
Ciudad Autónoma de Buenos Aires , Buenos Aires
Австралия (1)
GenesisCare North Shore ( Site 1103)
St Leonards , New South Wales
Белгия (1)
AZ Maria Middelares-IKG ( Site 1305)
Ghent , Oost-Vlaanderen
Бразилия (1)
Hospital São Domingos ( Site 1365)
São Luís , Maranhão
Канада (1)
Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413)
Calgary , Alberta
Chile (1)
James Lind Centro de Investigacion del Cancer ( Site 1504)
Temuco , Araucania
Китай (1)
Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635)
Hefei , Anhui
Чехия (1)
Fakultní Nemocnice Brno-Gynekologicko-porodnicka klinika ( Site 1704)
Brno , Brno-mesto
Дания (1)
Herlev and Gentofte Hospital-Department of Oncology ( Site 1801)
Copenhagen , Capital Region
Финландия (1)
Kuopion Yliopistollinen Sairaala ( Site 1904)
Kuopio , Northern Savonia
Франция (1)
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 2002)
Bordeaux , Aquitaine
Гърция (1)
Agios Andreas Hospital Patras ( Site 2201)
Pátrai , Achaia
Ireland (1)
Cork University Hospital ( Site 2402)
Cork
Израел (1)
Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502)
Haifa
Италия (1)
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-SSD Oncologia medica Addarii ( Site 2603)
Bologna , Emilia-Romagna
Япония (1)
Aichi Cancer Center ( Site 2714)
Nagoya , Aichi-ken
Malaysia (1)
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803)
Kuala Lumpur
Mexico (1)
COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2902)
Coyoacán , Mexico City
Нидерландия (1)
Radboudumc-Medical Oncology ( Site 3003)
Nijmegen , Gelderland
Норвегия (1)
Stavanger Universitetssykehus ( Site 3103)
Stavanger , Rogaland
Полша (1)
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek ( Site 3202)
Poznan , Greater Poland Voivodeship
Puerto Rico (1)
Ad-Vance Medical Research-Research ( Site 3302)
Ponce
Сингапур (1)
National Cancer Centre Singapore-Medical Oncology ( Site 3401)
Singapore , Central Singapore
Южна Корея (1)
Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505)
Seongnam , Kyonggi-do
Испания (1)
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608)
L'Hospitalet de Llobregat , Barcelona
Швеция (1)
Skånes Universitetssjukhus Lund ( Site 3702)
Lund , Skåne County
Великобритания (1)
University Hospitals Sussex NHS Foundation Trust ( Site 4006)