Trial Outcomes & Findings for Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma (NCT NCT05200143)
NCT ID: NCT05200143
Last Updated: 2024-09-19
Results Overview
Progression free survival (PFS) will be defined as the time between the date of enrollment and the first date of documented progression (per iRECIST), as determined by the investigator, or death due to any cause, whichever occurs first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
7 Months
Results posted on
2024-09-19
Participant Flow
Enrollment was closed early due to withdrawn support from BMS (supplied Nivolumab).
Participant milestones
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma
Baseline characteristics by cohort
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
n=4 Participants
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 0 (Asymptomatic)
|
3 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 1 (Symptomatic but completely ambulatory)
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 2 (Symptomatic, <50% in bed during the day)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 3 (Symptomatic, >50% in bed, but not bedbound)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 4 (Bedbound)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 5 (Death)
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 MonthsPopulation: 1 of the 4 patients withdrew consent after completing treatment per protocol and moved abroad.
Progression free survival (PFS) will be defined as the time between the date of enrollment and the first date of documented progression (per iRECIST), as determined by the investigator, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
n=3 Participants
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Progression Free Survival of the Triplet Combination of Ipilimumab + Nivolumab + Cabozantinib in Patients With Anti-PD-1/PD-L1 Refractory Metastatic Cutaneous Melanoma
|
6.24 Months
Interval 4.6 to 6.37
|
SECONDARY outcome
Timeframe: 13 MonthsNumber of patients who reported incidence of grade ≥3 treatment related adverse events.
Outcome measures
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
n=4 Participants
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Safety/Tolerability (CTCAE v5.0)
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 1 of the 4 patients withdrew consent after completing treatment per protocol and moved abroad.
Number of patients who reached the 12 month overall survival timepoint.
Outcome measures
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
n=3 Participants
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Overall Survival
|
0 Participants
|
Adverse Events
Ipilimumab + Nivolumab + Cabozantinib
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
n=4 participants at risk
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Endocrine disorders
Hypophysitis
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Infections and infestations
Hepatitis
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Endocrine disorders
Adrenal Insufficiency
|
25.0%
1/4 • Number of events 2 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Lower Extremity Pain
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
Other adverse events
| Measure |
Ipilimumab + Nivolumab + Cabozantinib
n=4 participants at risk
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain/discomfort
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Investigations
ALT increased
|
50.0%
2/4 • Number of events 6 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • Number of events 2 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Investigations
AST increased
|
50.0%
2/4 • Number of events 5 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Blistering (hands/feet)
|
25.0%
1/4 • Number of events 2 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Investigations
Blood LDH increased
|
75.0%
3/4 • Number of events 3 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Investigations
CK increased
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 4 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
General disorders
Edema, bilateral lower extremity
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Erythematous papular rash, bilateral calves
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Flank pain, right
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Eye disorders
Floaters, intermittent
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis (Night Sweats)
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Endocrine disorders
Hyperthyroidism
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
2/4 • Number of events 3 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Investigations
Lipase increased
|
25.0%
1/4 • Number of events 2 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp, bilateral feet
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Myalgia, right shoulder/trapezius
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 2 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Pain, right index finger
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Nervous system disorders
Paresthesia, bilateral hands/feet
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Infections and infestations
Paronychia, intermittent
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform, scalp
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous papular, chest/abdomen
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash, bilateral ankles
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation (vitiligo)
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Skin pain, palm of left hand
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Skin wound, lower legs
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Stomach pain
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
|
Nervous system disorders
Stroke
|
25.0%
1/4 • Number of events 1 • 1 year, 1 month
Adverse events were collected on Day 1 of each cycle. All adverse events collected as part of the study have been reported to ClinicalTrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place