MK-2870-036 - A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22).

Studio Clinico

Patologia: Tumori dell’utero

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Mantenimento

Criteri di inclusione: 

The main inclusion criteria include but are not limited to the following:

- Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
 - Has persistent, recurrent, or newly diagnosed metastatic cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
- If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
- If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1
- Has tumor programmed cell death ligand 1 expression of combined positive score ≥1.

Criteri di esclusione: 

The main exclusion criteria include but are not limited to the following:

- Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- 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 (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has received prior systemic anticancer therapy other than what is specified in this protocol
- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
- Has a diagnosis of immunodeficiency
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications.

Trattamento sperimentale: 

Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab
Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab

Trattamento di controllo: 

Part 2: Pembrolizumab +/- Bevacizumab

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-521514-26-00

Data di inserimento: 16.03.2026

Data di aggiornamento: 15.06.2026

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -