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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

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ClinicalTrials.gov Identifier: NCT03661320
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Bladder Cancer Muscle-Invasive Bladder Cancer BMS-986205 Biological: Nivolumab Drug: BMS-986205 Drug: Gemcitabine Drug: Cisplatin Drug: BMS-986205 Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: partially blinded
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : November 28, 2023
Estimated Study Completion Date : December 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
Chemotherapy alone followed by radical cystectomy
 Drug: Gemcitabine
Specified dose on specified day
Other Name: Chemotherapy

Drug: Cisplatin
Specified dose on specified day
Other Name: Chemotherapy
Experimental: Arm B
BMS-986205 Placebo + Nivolumab + Chemotherapy followed by BMS-986205 Placebo + Nivolumab post radical cystectomy
 Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Drug: Gemcitabine
Specified dose on specified day
Other Name: Chemotherapy

Drug: Cisplatin
Specified dose on specified day
Other Name: Chemotherapy

Drug: BMS-986205 Placebo
Specified dose on specified day
Experimental: Arm C
BMS-986205 + Nivolumab + Chemotherapy followed by Nivolumab plus BMS-986205 post radical cystectomy
 Biological: Nivolumab
Specified dose on specified day
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified dose on specified day

Drug: Gemcitabine
Specified dose on specified day
Other Name: Chemotherapy

Drug: Cisplatin
Specified dose on specified day
Other Name: Chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approx. 39 months ]
    Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A

  2. Event-Free Survival (EFS), in all randomized participants [ Time Frame: Approx. 57 months ]
    Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A;


Secondary Outcome Measures :
  1. Overall Survival (OS) in all randomized participants [ Time Frame: Approx. 76 months ]
    Comparison of Arm C vs Arm A; and Comparison of Arm B vs Arm A

  2. Incidence of Adverse Events (AE) in all treated participants [ Time Frame: Approx. 76 months ]
  3. Incidence of Serious Adverse Events (SAE) in all treated participants [ Time Frame: Approx. 76 months ]
  4. Incidence of Laboratory abnormalities in all treated participants [ Time Frame: Approx. 76 months ]
  5. Incidence of death in all treated participants [ Time Frame: Approx. 76 months ]
  6. Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approx. 39 months ]
    Comparison of Arm B v Arm C

  7. Event Free Survival (EFS), in all randomized participants [ Time Frame: Approx. 57 months ]
    Comparison of Arm B v Arm C


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661320


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03661320    
Other Study ID Numbers: CA017-078
2017-004692-31 ( EudraCT Number )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Nivolumab
Linrodostat
Antineoplastic Agents
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors