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Trial record 1 of 1 for:    NCT03661320
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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 : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date October 12, 2020
Actual Study Start Date  ICMJE October 12, 2018
Estimated Primary Completion Date November 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • 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
  • 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;
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Pathological Complete Response (pCR) rate of neoadjuvant Nivo/BMS-986205 +Chemo [ Time Frame: Approx. 39 months ]
    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
  • Event-Free Survival (EFS) of neoadjuvant Nivo/BMS-986205 + Chemo followed by continued Nivo/BMS-986205 after RC [ Time Frame: Approx. 57 months ]
    Defined as the time from randomization to any of the following events: progression of disease that precludes RC surgery, local or distant recurrence, based on BICR assessments, or death due to any cause
  • Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone [ Time Frame: Approx. 39 months ]
    Defined as number of randomized participants with absence of any cancer (T0, N0, M0) in pathology specimens after RC, based on blinded pathology review
  • Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo [ Time Frame: Approx. 39 months ]
    Defined as number of randomized participants with absence of any cancer (T0, N0, M0) in pathology specimens after RC, based on blinded pathology review
  • Event-Free Survival (EFS) of SOC Chemo after RC [ Time Frame: Approx. 57 months ]
    Defined as the time from randomization to any of the following events: progression of disease that precludes RC surgery, local or distant recurrence, based on BICR assessments, or death due to any cause
  • Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC [ Time Frame: Approx. 57 months ]
    Defined as the time from randomization to any of the following events: progression of disease that precludes RC surgery, local or distant recurrence, based on BICR assessments, or death due to any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
  • 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
  • Incidence of Adverse Events (AE) in all treated participants [ Time Frame: Approx. 76 months ]
  • Incidence of Serious Adverse Events (SAE) in all treated participants [ Time Frame: Approx. 76 months ]
  • Incidence of Laboratory abnormalities in all treated participants [ Time Frame: Approx. 76 months ]
  • Incidence of death in all treated participants [ Time Frame: Approx. 76 months ]
  • Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approx. 39 months ]
    Comparison of Arm B v Arm C
  • Event Free Survival (EFS), in all randomized participants [ Time Frame: Approx. 57 months ]
    Comparison of Arm B v Arm C
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Overall Survival (OS) [ Time Frame: Approx. 76 months ]
    Defined as the time between the date of randomization and the date of death from any cause in all randomized patients
  • Incidence of Adverse Events (AE) [ Time Frame: Approx. 76 months ]
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: Approx. 76 months ]
  • Incidence of Laboratory abnormalities [ Time Frame: Approx. 76 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
partially blinded
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Muscle-Invasive Bladder Cancer
  • BMS-986205
Intervention  ICMJE
  • 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
  • Drug: BMS-986205 Placebo
    Specified dose on specified day
Study Arms  ICMJE
  • Active Comparator: Arm A
    Chemotherapy alone followed by radical cystectomy
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • Experimental: Arm B
    BMS-986205 Placebo + Nivolumab + Chemotherapy followed by BMS-986205 Placebo + Nivolumab post radical cystectomy
    Interventions:
    • Biological: Nivolumab
    • Drug: Gemcitabine
    • Drug: Cisplatin
    • Drug: BMS-986205 Placebo
  • Experimental: Arm C
    BMS-986205 + Nivolumab + Chemotherapy followed by Nivolumab plus BMS-986205 post radical cystectomy
    Interventions:
    • Biological: Nivolumab
    • Drug: BMS-986205
    • Drug: Gemcitabine
    • Drug: Cisplatin
Publications * Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2026
Estimated Primary Completion Date November 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Denmark,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661320
Other Study ID Numbers  ICMJE CA017-078
2017-004692-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP