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  • NCT03661320

Active, Not Recruiting

A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC - CA017-078

Uppdaterad: 29 januari, 2024   |   ClinicalTrials.gov

Utskriftsvänlig sammanfattning

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Information om prövningen

  • Phase 3

    Fas

  • Kön

  • 18+

    Åldersintervall

  • Active, Not Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Active Comparator: Arm A
Drug: BMS-986205, Gemcitabine
Experimental: Arm B
Biological: Nivolumab Drug: Gemcitabine, BMS-986205

Viktiga kriterier för deltagandet

Inclusion Criteria: - Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component. - Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Exclusion Criteria: - Clinical evidence of positive LN (≥ 10 mm in short axis) or metastatic bladder cancer - Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted - Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min

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