Description:
A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed
by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant
standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer
(MIBC)
Title
- Brief Title: 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
- Official Title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA017-078
- SECONDARY ID:
2017-004692-31
- NCT ID:
NCT03661320
Conditions
- Bladder Cancer
- Muscle-Invasive Bladder Cancer
- BMS-986205
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Arm B |
BMS-986205 | | Arm C |
Gemcitabine | Chemotherapy | Arm A |
Cisplatin | Chemotherapy | Arm A |
BMS-986205 Placebo | | Arm B |
Purpose
A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed
by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant
standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer
(MIBC)
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Active Comparator | Chemotherapy Alone | |
Arm B | Experimental | BMS-986205 Placebo + Nivolumab + Chemotherapy | - Nivolumab
- Gemcitabine
- Cisplatin
- BMS-986205 Placebo
|
Arm C | Experimental | BMS-986205 + Nivolumab + Chemotherapy | - Nivolumab
- BMS-986205
- Gemcitabine
- Cisplatin
|
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Pathological Complete Response (pCR) rate of neoadjuvant Nivo/BMS-986205 +Chemo |
Time Frame: | Approx. 39 months |
Safety Issue: | |
Description: | Defined as number of randomized participants with absence of any cancer (T0, N0, M0) in pathology specimens after Radical Cystectomy (RC) based on blinded pathology review |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Approx. 76 months |
Safety Issue: | |
Description: | Defined as the time between the date of randomization and the date of death from any cause in all randomized patients |
Measure: | Incidence of Adverse Events (AE) |
Time Frame: | Approx. 76 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAE) |
Time Frame: | Approx. 76 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Laboratory abnormalities |
Time Frame: | Approx. 76 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
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