Melanoma, Skin Cancer
Conditions
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
Interventions
DRUGBMS-986205
specified dose on specified day
BIOLOGICALNivolumab
Specified dose on specified day
DRUGPlacebo
Specified dose on specified day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | 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 |
Countries
Australia, Canada, Czechia, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Spain, Switzerland, United Kingdom, United States
Participant flow
Pre-assignment details
20 participants were randomized and treated.
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab + BMS-986205 Nivolumab 480 mg IV Q4W + BMS-986205 100 mg PO QD | 10 |
| Nivolumab Nivolumab 480 mg IV Q4W | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease progression | 4 | 6 |
| Overall Study | Other reasons | 2 | 2 |
| Overall Study | Participant request to discontinue treatment | 0 | 1 |
| Overall Study | Participant withdrew consent | 1 | 0 |
| Overall Study | Study drug toxicity | 1 | 0 |
Baseline characteristics
| Characteristic | Nivolumab + BMS-986205 | Nivolumab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 3 / 10 |
| other Total, other adverse events | 10 / 10 | 9 / 10 |
| serious Total, serious adverse events | 4 / 10 | 4 / 10 |
Outcome results
Primary
Number of Participants Experiencing Adverse Events
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
Time frame: From first dose to 30 days following last dose (up to approximately 25 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | Drug-related SAEs (any grade) | 1 Participants |
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | Any cause AEs (any grade) | 10 Participants |
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | Any cause SAEs (any grade) | 3 Participants |
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | Drug-related AEs (any grade) | 9 Participants |
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | SAEs leading to discontinuation | 1 Participants |
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | Drug-Related Non-serious AEs leading to discontinuation | 0 Participants |
| Nivolumab + BMS-986205 | Number of Participants Experiencing Adverse Events | Deaths | 0 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | Drug-Related Non-serious AEs leading to discontinuation | 0 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | Deaths | 0 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | Any cause SAEs (any grade) | 3 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | Drug-related SAEs (any grade) | 0 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | SAEs leading to discontinuation | 0 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | Any cause AEs (any grade) | 9 Participants |
| Nivolumab | Number of Participants Experiencing Adverse Events | Drug-related AEs (any grade) | 7 Participants |