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A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03661320
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : January 26, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Muscle-Invasive Bladder Cancer Biological: Nivolumab Drug: Gemcitabine Drug: Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 861 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : November 6, 2018
Estimated Primary Completion Date : November 3, 2023
Estimated Study Completion Date : December 30, 2027

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: Gemcitabine/Cisplatin (GC) Chemotherapy Drug: Gemcitabine
Specified dose on specified days
Other Name: Chemotherapy

Drug: Cisplatin
Specified dose on specified days
Other Name: Chemotherapy
Experimental: Arm B: Nivolumab + GC Chemotherapy Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approximately 43 months ]
    Arm B vs. Arm A

  2. Event-Free Survival (EFS), in all randomized participants [ Time Frame: Approximately 51 months ]
    Arm B vs. Arm A


Secondary Outcome Measures :
  1. Overall Survival (OS) in all randomized participants [ Time Frame: Approximately 60 months ]
    Arm B vs. Arm A

  2. Incidence of Adverse Events (AE) in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  3. Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  4. Incidence of deaths in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  5. Incidence of laboratory abnormalities in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  6. pCR rate, descriptively in all concurrently randomized participants [ Time Frame: Approximately 43 months ]
    Arm C vs. Arm B and Arm A

  7. EFS, descriptively in all concurrently randomized participants [ Time Frame: Approximately 51 months ]
    Arm C vs. Arm B and Arm A

  8. OS, descriptively in all concurrently randomized participants [ Time Frame: Approximately 60 months ]
    Arm C vs. Arm B and Arm A


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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 lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
  • Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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: January 26, 2023
Last Verified: January 2023

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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
Cisplatin
Nivolumab
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