A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder (CheckMate 9UT)
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| ClinicalTrials.gov Identifier: NCT03519256 |
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Recruitment Status :
Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : April 27, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Bladder Neoplasms | Biological: Nivolumab Biological: BCG Drug: BMS-986205 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 69 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer |
| Actual Study Start Date : | August 2, 2018 |
| Estimated Primary Completion Date : | October 16, 2022 |
| Estimated Study Completion Date : | October 16, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Bladder cancer
MedlinePlus related topics:
Bladder Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Nivolumab monotherapy |
Biological: Nivolumab
Specified dose on specified days
Other Names:
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| Experimental: Nivolumab + BCG |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: BCG Specified dose on specified days
Other Name: Bacillus Calumette-Guerin |
| Experimental: Nivolumab + BMS-986205 |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: BMS-986205 Specified dose on specified days |
| Experimental: Nivolumab + BMS-986205 + BCG |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: BCG Specified dose on specified days
Other Name: Bacillus Calumette-Guerin Drug: BMS-986205 Specified dose on specified days |
Primary Outcome Measures :
- Incidence of Adverse Events (AEs) in all treated participants [ Time Frame: Up to week 67 ]
- Incidence of deaths in all treated participants [ Time Frame: Up to week 67 ]
- Incidence of laboratory abnormalities in all treated participants [ Time Frame: Up to week 67 ]
- Incidence of laboratory changes from baseline in all treated participants [ Time Frame: Up to week 67 ]
- Incidence of anti-nivolumab antibodies [ Time Frame: Up to week 67 ]
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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:
- Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
- Participants must have CIS to be eligible.
- Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria:
- Sign of locally advanced disease or metastatic bladder cancer
- Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
- Prior immuno-oncology therapy
Other protocol-defined inclusion/exclusion criteria apply
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): NCT03519256
Locations
Show 86 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03519256 |
| Other Study ID Numbers: |
CA209-9UT 2017-003581-27 ( EudraCT Number ) |
| First Posted: | May 8, 2018 Key Record Dates |
| Last Update Posted: | April 27, 2022 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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Bladder Cancer BCG-unresponsive Nivolumab Intravesical BCG |
NMIBC Non-Muscle Invasive BMS-986205 CheckMate 9UT |
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases |
Nivolumab Linrodostat Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |