An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03329846 |
|
Recruitment Status :
Completed
First Posted : November 6, 2017
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
|
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma Skin Cancer | Drug: BMS-986205 Biological: Nivolumab Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated |
| Actual Study Start Date : | November 30, 2017 |
| Actual Primary Completion Date : | July 2, 2020 |
| Actual Study Completion Date : | July 2, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Nivolumab + Placebo
Specified dose on specified day Participants will no longer receive BMS-986205 Placebo |
Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558 Drug: Placebo Specified dose on specified day
Other Name: BMS-986205 matching placebo |
|
Experimental: Nivolumab + BMS-986205
Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion |
Drug: BMS-986205
specified dose on specified day Biological: Nivolumab Specified dose on specified day
Other Name: BMS-936558 |
Primary Outcome Measures :
- Number of Participants Experiencing Adverse Events [ Time Frame: From first dose to 30 days following last dose (up to approximately 25 months) ]Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 12 years and older unless not permitted by local regulations; in that case 18 years old and older
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
- Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
- Measurable disease per RECIST v1.1
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Uveal or ocular melanoma
- Participants with active, known, or suspected autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Other protocol defined inclusion/exclusion criteria could 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): NCT03329846
Locations
Show 63 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study Documents (Full-Text)
Documents provided by Bristol-Myers Squibb:
Documents provided by Bristol-Myers Squibb:
Study Protocol [PDF] October 25, 2018
Statistical Analysis Plan [PDF] July 23, 2020
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03329846 |
| Other Study ID Numbers: |
CA017-055 2017-002499-14 ( EudraCT Number ) |
| First Posted: | November 6, 2017 Key Record Dates |
| Results First Posted: | July 9, 2021 |
| Last Update Posted: | July 9, 2021 |
| Last Verified: | June 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Nivolumab Linrodostat Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |