Melanoma
Conditions
Keywords
Skin Cancer, rHuPH20, OPDIVO®
Brief summary
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
Interventions
BIOLOGICALNivolumab/rHuPH20
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins * Complete resection performed within 12 weeks prior to randomization or treatment assignment * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Exclusion criteria
* History of uveal or mucosal melanoma * Untreated/unresected CNS metastases or leptomeningeal metastases * Active, known or suspected autoimmune disease * Serious or uncontrolled medical disorder 4 weeks prior to screening * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible * Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose to 100 days post last dose (Approximately up to 14 Months) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Number of Participants With Serious Adverse Events | From first dose to 100 days post last dose (Approximately up to 14 Months) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Number of Participants With Treatment Related Adverse Events | From first dose to 100 days post last dose (Approximately up to 14 Months) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease. |
| Number of Participants With Treatment Related Serious Adverse Events | From first dose to 100 days post last dose (Approximately up to 14 Months) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization. |
Countries
Australia, Belgium, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
14 participants were randomized and treated
Participants by arm
| Arm | Count |
|---|---|
| Arm A Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1. | 6 |
| Arm B * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4.
* Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks.
* All dosing will be performed in-clinic. | 8 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease recurrence | 1 | 0 |
| Overall Study | Other Reasons | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 6 / 6 | 8 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Number of Participants With Adverse Events | Grade 3 to 4 | 0 Participants |
| Arm A | Number of Participants With Adverse Events | Any Grade | 6 Participants |
| Arm A | Number of Participants With Adverse Events | Grade 5 | 0 Participants |
| Arm B | Number of Participants With Adverse Events | Any Grade | 8 Participants |
| Arm B | Number of Participants With Adverse Events | Grade 3 to 4 | 2 Participants |
| Arm B | Number of Participants With Adverse Events | Grade 5 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Number of Participants With Serious Adverse Events | Grade 3 to 4 | 0 Participants |
| Arm A | Number of Participants With Serious Adverse Events | Any Grade | 0 Participants |
| Arm A | Number of Participants With Serious Adverse Events | Grade 5 | 0 Participants |
| Arm B | Number of Participants With Serious Adverse Events | Any Grade | 0 Participants |
| Arm B | Number of Participants With Serious Adverse Events | Grade 3 to 4 | 0 Participants |
| Arm B | Number of Participants With Serious Adverse Events | Grade 5 | 0 Participants |
Primary
Number of Participants With Treatment Related Adverse Events
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Number of Participants With Treatment Related Adverse Events | Any Grade | 6 Participants |
| Arm A | Number of Participants With Treatment Related Adverse Events | Grade 3 to 4 | 0 Participants |
| Arm A | Number of Participants With Treatment Related Adverse Events | Grade 5 | 0 Participants |
| Arm B | Number of Participants With Treatment Related Adverse Events | Grade 5 | 0 Participants |
| Arm B | Number of Participants With Treatment Related Adverse Events | Any Grade | 8 Participants |
| Arm B | Number of Participants With Treatment Related Adverse Events | Grade 3 to 4 | 2 Participants |
Primary
Number of Participants With Treatment Related Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A | Number of Participants With Treatment Related Serious Adverse Events | Any Grade | 0 Participants |
| Arm A | Number of Participants With Treatment Related Serious Adverse Events | Grade 3 to 4 | 0 Participants |
| Arm A | Number of Participants With Treatment Related Serious Adverse Events | Grade 5 | 0 Participants |
| Arm B | Number of Participants With Treatment Related Serious Adverse Events | Any Grade | 0 Participants |
| Arm B | Number of Participants With Treatment Related Serious Adverse Events | Grade 3 to 4 | 0 Participants |
| Arm B | Number of Participants With Treatment Related Serious Adverse Events | Grade 5 | 0 Participants |