Melanoma
Conditions
Keywords
Patient preference, Nivolumab Relatlimab IV, Nivolumab Relatimab SC, Melanoma, rHuPH20, FDC IV, FDC SC, Adjuvant, Metastatic, Switch, Nivolumab, Relatlimab
Brief summary
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
Interventions
Specified dose on specified days
DRUGrelatlimab+nivolumab+rHuPH20
Specified dose on specified days
DRUGnivolumab
Specified dose on specified days
DRUGnivolumab+rHuPH20
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease * Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma
Exclusion criteria
* Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose | Cycle 4 Day 1 (each cycle consist of 4 weeks) | PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Deaths | First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months) | An adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes. |
| Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event | From first dose (Day 1) and up to study completion (up to approximately 45 months) | — |
Countries
Chile, Greece, Italy, Spain, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized < 65 | 48 Participants |
| Age, Customized >= 65 | 52 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized HISPANIC OR LATINO | 3 Participants |
| Race/Ethnicity, Customized NOT HISPANIC OR LATINO | 79 Participants |
| Race/Ethnicity, Customized Not reported | 7 Participants |
| Race/Ethnicity, Customized NOT REPORTED | 7 Participants |
| Race/Ethnicity, Customized White | 92 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 50 | 2 / 50 |
| other Total, other adverse events | 44 / 50 | 41 / 50 |
| serious Total, serious adverse events | 21 / 50 | 6 / 50 |
Outcome results
None listed