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MK-2870-005 - A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (ENGOT-en23/GOG-3095)

Studio Clinico

Patologia: Tumori dell’utero

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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 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 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting.
- Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. 

Trattamento sperimentale: 

Sacituzumab tirumotecan

Trattamento di controllo: 

Chemotherapy

Centri partecipanti

Nord Italia

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
Ostetricia e Ginecologia

Email: ostetricia.ginecologia2@asst-spedalicivili.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof.ssa Nicoletta Colombo
Telefono: 0257489543

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
UO di Oncologia medica ed Ematologia

 

AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
S.C.D.U. Ginecologia e Ostetricia

Riferimento: Prof.ssa Annamaria Ferrero
Email: annamaria.ferrero@unito.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Ginecologia Oncologica

Riferimento: Prof. Giovanni Scambia
Email: giovanni.scambia@policlinicogemelli.it

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
S.C. Oncologia Sperimentale Uro-Genitale

Riferimento: Dr.ssa Carmela Pisano
Email: c.pisano@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-504816-14

Data di inserimento: 04.07.2024

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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