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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

NCT03661320

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)

Related Conditions:
  • Bladder Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03661320

Trial Eligibility

Document

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

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Arm B
BMS-986205Arm C
GemcitabineChemotherapyArm A
CisplatinChemotherapyArm A
BMS-986205 PlaceboArm 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

NameTypeDescriptionInterventions
Arm AActive ComparatorChemotherapy alone followed by radical cystectomy
  • Gemcitabine
  • Cisplatin
Arm BExperimentalBMS-986205 Placebo + Nivolumab + Chemotherapy followed by BMS-986205 Placebo + Nivolumab post radical cystectomy
  • Nivolumab
  • Gemcitabine
  • Cisplatin
  • BMS-986205 Placebo
Arm CExperimentalBMS-986205 + Nivolumab + Chemotherapy followed by Nivolumab plus BMS-986205 post radical cystectomy
  • 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, in all randomized participants
Time Frame:Approx. 39 months
Safety Issue:
Description:Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A

Secondary Outcome Measures

Measure:Overall Survival (OS) in all randomized participants
Time Frame:Approx. 76 months
Safety Issue:
Description:Comparison of Arm C vs Arm A; and Comparison of Arm B vs Arm A
Measure:Incidence of Adverse Events (AE) in all treated participants
Time Frame:Approx. 76 months
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAE) in all treated participants
Time Frame:Approx. 76 months
Safety Issue:
Description:
Measure:Incidence of Laboratory abnormalities in all treated participants
Time Frame:Approx. 76 months
Safety Issue:
Description:
Measure:Incidence of death in all treated participants
Time Frame:Approx. 76 months
Safety Issue:
Description:
Measure:Pathological Complete Response (pCR) rate, in all randomized participants
Time Frame:Approx. 39 months
Safety Issue:
Description:Comparison of Arm B v Arm C
Measure:Event Free Survival (EFS), in all randomized participants
Time Frame:Approx. 57 months
Safety Issue:
Description:Comparison of Arm B v Arm C

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

August 25, 2021