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NCT Number: NCT03661320

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle-invasive Bladder Cancer Neoplasms Neoplasms by Site Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0051, Capital Federal, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Gemcitabine

Drug

Specified dose on specified days

Other names: Chemotherapy

Cisplatin

Drug

Specified dose on specified days

Other names: Chemotherapy

Primary outcomes

  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 36 months

    Arm B vs. Arm A

Secondary outcomes

  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 36 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Sep 7, 2018
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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