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Clinical Trials/EUCTR2017-004692-31-GR
EUCTR2017-004692-31-GR
Active, not recruiting
Phase 1

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

Bristol-Myers Squibb International Corporation0 sites1,600 target enrollmentJanuary 7, 2019
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ConditionsBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo (100 mg/10 ml)Gemsol, 40 mg/ml concentrate for solution for infusionCisplatin Teva® 1 mg/ml concentrate for solution for infusionCisplatin-Ebewe, 1 mg/ml, concentrate for solution for infusion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bladder CancerMuscle-Invasive Bladder Cancer
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
1600
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 7, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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 RC by his/her oncologist and/or urologist, and must agree to undergo RC after completion of neoadjuvant therapy.
  • •\-Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 480
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 1120

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
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 MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-004692-31-ATBristol-Myers Squibb International Corporation1,600
Active, not recruiting
Phase 1
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 MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-004692-31-NLBristol-Myers Squibb International Corporation1,600
Active, not recruiting
Phase 1
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
EUCTR2017-004692-31-BEBristol-Myers Squibb International Corporation1,200
Active, not recruiting
Phase 1
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 MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-004692-31-DEBristol-Myers Squibb International Corporation1,600
Active, not recruiting
Phase 1
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 MIBCBladder CancerMuscle-Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10022877Term: Invasive bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-004692-31-NOBristol-Myers Squibb International Corporation1,600