Trial Outcomes & Findings for Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma (NCT NCT02970981)
NCT ID: NCT02970981
Last Updated: 2024-04-30
Results Overview
Number of participants who are relapse-free at 48 months after initiating treatment in the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Month 48 Post-Treatment Initiation
Results posted on
2024-04-30
Participant Flow
18 participants were enrolled in the study; 2 participants were deemed ineligible before starting the study.
Participant milestones
| Measure |
Nivolumab and Ipilimumab
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Received Intervention
|
16
|
|
Overall Study
Completed Induction Therapy (4 Cycles)
|
15
|
|
Overall Study
Completed Maintenance Therapy (48 Weeks)
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nivolumab and Ipilimumab
n=16 Participants
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Age, Customized
>= 16 years
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=16 Participants
|
|
Disease Stage at Entry
IIIB
|
6 Participants
n=16 Participants
|
|
Disease Stage at Entry
IIIC
|
5 Participants
n=16 Participants
|
|
Disease Stage at Entry
IV
|
4 Participants
n=16 Participants
|
|
Disease Stage at Entry
IIB
|
1 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Month 48 Post-Treatment InitiationNumber of participants who are relapse-free at 48 months after initiating treatment in the study.
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=16 Participants
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Relapse-Free Survival
|
12 Participants
|
SECONDARY outcome
Timeframe: Month 12 Post-Treatment InitiationThe adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) V4.
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=16 Participants
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Number of Cases of Adverse Events Occurring During Study
|
238 cases of adverse events
|
SECONDARY outcome
Timeframe: Month 48 Post-Treatment InitiationPercentage of participants who are alive at at 48 months after initiating treatment in the study.
Outcome measures
| Measure |
Nivolumab and Ipilimumab
n=16 Participants
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Overall Survival
|
16 Participants
|
Adverse Events
Nivolumab and Ipilimumab
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab and Ipilimumab
n=16 participants at risk
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
6.2%
1/16 • Number of events 1 • 48 weeks post-treatment
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 1 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • 48 weeks post-treatment
|
|
Blood and lymphatic system disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • 48 weeks post-treatment
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • 48 weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
6.2%
1/16 • Number of events 1 • 48 weeks post-treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • 48 weeks post-treatment
|
Other adverse events
| Measure |
Nivolumab and Ipilimumab
n=16 participants at risk
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
Nivolumab
Ipilimumab
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
18.8%
3/16 • 48 weeks post-treatment
|
|
Hepatobiliary disorders
Increase in alanine aminotransferase
|
18.8%
3/16 • 48 weeks post-treatment
|
|
General disorders
Increase in Alkalina Phosphatase
|
6.2%
1/16 • 48 weeks post-treatment
|
|
General disorders
Allergic rhinitis
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
4/16 • 48 weeks post-treatment
|
|
Psychiatric disorders
Anorexia
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Bloating
|
12.5%
2/16 • 48 weeks post-treatment
|
|
General disorders
Blurred vision
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chest wall discomfort
|
6.2%
1/16 • 48 weeks post-treatment
|
|
General disorders
Chills
|
18.8%
3/16 • 48 weeks post-treatment
|
|
Eye disorders
Conjunctivitis
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Metabolism and nutrition disorders
Increase in Creatinine
|
6.2%
1/16 • 48 weeks post-treatment
|
|
General disorders
Dehydration
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
6/16 • 48 weeks post-treatment
|
|
General disorders
Dry mouth
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Eye disorders
Green floater in eye
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Blood and lymphatic system disorders
Edema
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
12.5%
2/16 • 48 weeks post-treatment
|
|
General disorders
Fever
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
GERD
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Loose stool
|
43.8%
7/16 • 48 weeks post-treatment
|
|
General disorders
Alopecia
|
6.2%
1/16 • 48 weeks post-treatment
|
|
General disorders
Malaise
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
5/16 • 48 weeks post-treatment
|
|
General disorders
Nasal congestion
|
31.2%
5/16 • 48 weeks post-treatment
|
|
General disorders
Non productive cough
|
6.2%
1/16 • 48 weeks post-treatment
|
|
General disorders
Nausea
|
37.5%
6/16 • 48 weeks post-treatment
|
|
General disorders
General pain
|
56.2%
9/16 • 48 weeks post-treatment
|
|
Skin and subcutaneous tissue disorders
Papulopostular rash
|
18.8%
3/16 • 48 weeks post-treatment
|
|
Blood and lymphatic system disorders
Decrease in platelet count
|
6.2%
1/16 • 48 weeks post-treatment
|
|
General disorders
Productive cough
|
12.5%
2/16 • 48 weeks post-treatment
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
100.0%
16/16 • Number of events 17 • 48 weeks post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
100.0%
16/16 • Number of events 30 • 48 weeks post-treatment
|
|
Infections and infestations
Sore throat
|
18.8%
3/16 • 48 weeks post-treatment
|
|
Renal and urinary disorders
Urinary urgency
|
6.2%
1/16 • 48 weeks post-treatment
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • 48 weeks post-treatment
|
Additional Information
Jeffrey S. Weber, MD, PhD
NYU Langone Health - Perlmutter Cancer Center
Phone: 212 731 6262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place