Trial Outcomes & Findings for Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma (NCT NCT04552223)
NCT ID: NCT04552223
Last Updated: 2025-02-13
Results Overview
Objective response rate (ORR) will be the percentage of study participants with a confirmed complete response (CR) or partial response PR to study therapy as per treating physician evaluation using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
Nivolumab Plus Relatlimab Group
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Nivolumab: Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
Relatlimab: Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Nivolumab Plus Relatlimab Group
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Nivolumab: Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
Relatlimab: Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab Plus Relatlimab Group
n=27 Participants
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Nivolumab: Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
Relatlimab: Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Participants that completed at least two cycles of study treatment.
Objective response rate (ORR) will be the percentage of study participants with a confirmed complete response (CR) or partial response PR to study therapy as per treating physician evaluation using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
Nivolumab Plus Relatlimab Group
n=26 Participants
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Nivolumab: Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
Relatlimab: Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
|
|---|---|
|
Objective Response Rate (ORR)
|
7.7 percentage of participants
Interval 1.0 to 25.1
|
SECONDARY outcome
Timeframe: Up to 24 monthsDisease control rate (DCR) is the proportion of patients with confirmed complete response (CR), partial response (PR), or stable disease (SD) as per treating physician evaluation using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsProgression-free survival (PFS) is defined as the time from the date of enrollment to the date that objective progression disease is documented or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsOverall survival (OS) is defined as the time from the date of enrollment to the date of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsDuration of response is defined as the time from the date of first documented response (CR or PR) until date of documented progression or death in the absence of disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 25 monthsThe safety profile of the study therapy will be determined by the proportion of study participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be tabulated by type, grade, severity, treatment attribution according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab Plus Relatlimab Group
Serious events: 3 serious events
Other events: 27 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Nivolumab Plus Relatlimab Group
n=27 participants at risk
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Nivolumab: Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
Relatlimab: Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
|
|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
General disorders
Edema limbs
|
3.7%
1/27 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Nivolumab Plus Relatlimab Group
n=27 participants at risk
Participants in this group will receive Nivolumab and Relatlimab administered together on Day 1 of every 4 week cycle. Both drugs will be administered until disease progression or intolerable toxicity for up to 24 months.
Nivolumab: Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
Relatlimab: Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
|
|---|---|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Endocrine disorders
Hypothyroidism
|
25.9%
7/27 • Number of events 7 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Investigations
Lipase increased
|
18.5%
5/27 • Number of events 9 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.8%
4/27 • Number of events 8 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
29.6%
8/27 • Number of events 8 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
General disorders
Pain
|
3.7%
1/27 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
Papulopustular rash
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Eye disorders
Periorbital edema
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions - Other, specify
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.8%
4/27 • Number of events 5 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Investigations
Serum amylase increased
|
14.8%
4/27 • Number of events 7 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.7%
1/27 • Number of events 2 • Up to 3 years
|
|
Investigations
Thyroid stimulating hormone increased
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Investigations
Weight loss
|
14.8%
4/27 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
48.1%
13/27 • Number of events 32 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
25.9%
7/27 • Number of events 9 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
14.8%
4/27 • Number of events 4 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.9%
7/27 • Number of events 10 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
48.1%
13/27 • Number of events 21 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
9/27 • Number of events 10 • Up to 3 years
|
|
Investigations
Cardiac troponin T increased
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Colitis
|
3.7%
1/27 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 2 • Up to 3 years
|
|
Investigations
Creatinine increased
|
29.6%
8/27 • Number of events 10 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
3/27 • Number of events 4 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
11.1%
3/27 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
14.8%
4/27 • Number of events 7 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.8%
4/27 • Number of events 5 • Up to 3 years
|
|
Renal and urinary disorders
Dysuria
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
General disorders
Edema limbs
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
1/27 • Number of events 2 • Up to 3 years
|
|
General disorders
Fatigue
|
55.6%
15/27 • Number of events 23 • Up to 3 years
|
|
General disorders
Fever
|
11.1%
3/27 • Number of events 3 • Up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.7%
1/27 • Number of events 1 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place