Patologia: Tumori dell’utero
Fase di studio: II
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Seconda linea, Terza/N linea
Criteri di inclusione:
- Ability to comprehend and willingness to sign a written ICF for the study. Women 18 years of age or older (or as applicable per local country requirements).
- Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
- Groups A and B: Have not been previously treated with a PD-(L)1 inhibitor.
- Group A only: Tumor tissue tested as MSI-High
- Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.
- Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
- Must have at least 1 measurable tumor lesion per RECIST v1.1.
- Willing to provide tumor tissue sample (fresh or archived).
- ECOG performance status 0 to 1.
- Willingness to avoid pregnancy.
Criteri di esclusione:
- Group A only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
- Histologically confirmed diagnosis of sarcoma of the uterus.
- Has disease eligible for potentially curative treatment.
- Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor.
- Groups C and D (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy.
- Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
- Receiving chronic systemic steroids (> 10 mg/day of prednisone or equivalent):
- Known active CNS metastases and/or carcinomatous meningitis.
- Has known active hepatitis B or C.
- Has received a live vaccine within 28 days of the planned start of study treatment.
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- Participants who are known to be HIV-positive with some protocol exceptions.
Retifanlimab, Epacadostat, Pemigatinib
Trattamento di controllo:
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Ospedale S. Maria di Ca’ Foncello
Piazzale Ospedale 1 - 31100 Treviso - TV
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Numero di iscrizione a registro: 2020‐000496‐20
Data di inserimento: 03.11.2021
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Meldola (FC)
Riferimento: Dr. Info non disponibile
Localita: Meldola (FC)