Trial Outcomes & Findings for A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (NCT NCT06101134)
NCT ID: NCT06101134
Last Updated: 2026-04-09
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Cycle 4 Day 1 (each cycle consist of 4 weeks)
Results posted on
2026-04-09
Participant Flow
Participant milestones
| Measure |
Cohort 1: Metastatic Melanoma
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
50
|
46
|
Reasons for withdrawal
| Measure |
Cohort 1: Metastatic Melanoma
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
|---|---|---|
|
Overall Study
Ongoing Treatment
|
23
|
37
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Progressive Disease
|
18
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Other reasons
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Baseline characteristics by cohort
| Measure |
Cohort 1: Metastatic Melanoma
n=50 Participants
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
n=50 Participants
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65
|
26 Participants
n=36 Participants
|
22 Participants
n=78 Participants
|
48 Participants
n=23 Participants
|
|
Age, Customized
>= 65
|
24 Participants
n=36 Participants
|
28 Participants
n=78 Participants
|
52 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=36 Participants
|
28 Participants
n=78 Participants
|
47 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=36 Participants
|
22 Participants
n=78 Participants
|
53 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
3 Participants
n=36 Participants
|
11 Participants
n=78 Participants
|
14 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
40 Participants
n=36 Participants
|
39 Participants
n=78 Participants
|
79 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
7 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
7 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=36 Participants
|
50 Participants
n=78 Participants
|
92 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
1 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
7 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
7 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Cycle 4 Day 1 (each cycle consist of 4 weeks)Population: PEPQ Evaluable population is defined as all enrolled participants who have received two doses of nivolumab + relatlimab FDC IV, two doses of nivolumab + relatlimab FDC SC and have answered Question 7 of the PEPQ
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.
Outcome measures
| Measure |
Cohort 1: Metastatic Melanoma
n=41 Participants
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
n=48 Participants
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
|---|---|---|
|
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
|
78.0 percentage of partcipants
Interval 62.4 to 89.4
|
70.8 percentage of partcipants
Interval 55.9 to 83.0
|
SECONDARY outcome
Timeframe: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months)Population: All treated subjects
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.
Outcome measures
| Measure |
Cohort 1: Metastatic Melanoma
n=50 Participants
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks untill disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
n=50 Participants
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
|---|---|---|
|
Number of Participants With Adverse Events and Deaths
Adverse Events
|
47 Participants
|
47 Participants
|
|
Number of Participants With Adverse Events and Deaths
Serious Adverse Events
|
16 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events and Deaths
Drug related Adverse Events
|
40 Participants
|
36 Participants
|
|
Number of Participants With Adverse Events and Deaths
Adverse events leading to discontinuation
|
3 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events and Deaths
Injection or infusion related adverse events
|
14 Participants
|
14 Participants
|
|
Number of Participants With Adverse Events and Deaths
Deaths
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events and Deaths
Other Events of Special Interest - Myasthenic syndrome
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose (Day 1) and up to study completion (up to approximately 45 months)Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Metastatic Melanoma
Serious events: 21 serious events
Other events: 44 other events
Deaths: 8 deaths
Cohort 2: Resected Melanoma
Serious events: 6 serious events
Other events: 41 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1: Metastatic Melanoma
n=50 participants at risk
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks until disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
n=50 participants at risk
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Endocrine disorders
Immune-mediated hyperthyroidism
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Asthenia
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Fatigue
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
General physical health deterioration
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected metastasis
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Nervous system disorders
Myasthenic syndrome
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Nervous system disorders
Optic neuritis
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Vascular disorders
Capillary leak syndrome
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
Other adverse events
| Measure |
Cohort 1: Metastatic Melanoma
n=50 participants at risk
Participants with Metastatic Melanoma were administered with fixed dose combination of Nivolumab 480 mg and Relatlimab 160 mg intravenously once in 4 weeks for 2 cycles followed by fixed dose combination of Nivolumab 960 mg and Relatlimab 320 mg and rHuPH20 subcutaneously once in 4 weeks until disease progression, unacceptable toxicity or up to 2 years total treatment duration.
|
Cohort 2: Resected Melanoma
n=50 participants at risk
Participants with Resected Melanoma were administered with Nivolumab 480 mg intravenously once in 4 weeks for 2 cycles followed by Nivolumab 1200 mg and rHuPH20 subcutaneously once in 4 weeks untill recurrence, unacceptable toxicity or up to 1 year of total treatment duration.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
10/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Asthenia
|
24.0%
12/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
20.0%
10/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Fatigue
|
28.0%
14/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
14.0%
7/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Injection site erythema
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Oedema peripheral
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
General disorders and administration site conditions
Pyrexia
|
12.0%
6/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Pharyngitis
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Investigations
Blood bilirubin increased
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Investigations
Blood creatine phosphokinase increased
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
8/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.0%
11/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
32.0%
16/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Nervous system disorders
Paraesthesia
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Psychiatric disorders
Insomnia
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.0%
8/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
20.0%
10/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Endocrine disorders
Adrenal insufficiency
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Endocrine disorders
Hyperthyroidism
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
10/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
12.0%
6/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Constipation
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
10/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
26.0%
13/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
2/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
8.0%
4/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Vascular disorders
Flushing
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Vascular disorders
Haematoma
|
0.00%
0/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
6.0%
3/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
10.0%
5/50 • AE, SAEs and all cause mortality was collected from first dose (Day 1) until primary completion date (up to approximately 17 months)
All treated population
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER