Trial Outcomes & Findings for Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma (NCT NCT01827111)
NCT ID: NCT01827111
Last Updated: 2022-02-08
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Results posted on
2022-02-08
Participant Flow
21 participants signed the consent, 2 participants did not received treatment (1) withdrew prior treatment and (1) not eligible due to angiosarcoma (no melanoma).
Participant milestones
| Measure |
ABI-007 + Ipilimumab
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.
Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ABI-007 + Ipilimumab
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.
Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
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|---|---|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
ABI-007 + Ipilimumab
n=18 Participants
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.
Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 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
|
18 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
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
ABI-007 + Ipilimumab
n=18 Participants
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
|
|---|---|
|
Median Overall Survival Response to Abraxane Plus Ipilimumab Therapy
|
24.9 months
Interval 0.0 to 49.0
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 monthsProgression-free survival (PFS) is the time from random assignment in a clinical trial to disease progression or death from any cause.
Outcome measures
| Measure |
ABI-007 + Ipilimumab
n=18 Participants
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
|
|---|---|
|
Median Progression Free Survival
|
10 months
Interval 0.0 to 27.2
|
Adverse Events
ABI-007 + Ipilimumab
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABI-007 + Ipilimumab
n=18 participants at risk
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
|
|---|---|
|
Investigations
Wound Infection
|
5.6%
1/18 • up to 50 months
|
|
Endocrine disorders
Hypophysitis
|
11.1%
2/18 • up to 50 months
|
|
Gastrointestinal disorders
Colitis
|
11.1%
2/18 • up to 50 months
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • up to 50 months
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • up to 50 months
|
|
General disorders
Fever
|
11.1%
2/18 • up to 50 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • up to 50 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
5.6%
1/18 • up to 50 months
|
|
Cardiac disorders
Hypotension
|
5.6%
1/18 • up to 50 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • up to 50 months
|
|
Eye disorders
Macular Cystoid
|
5.6%
1/18 • up to 50 months
|
Other adverse events
| Measure |
ABI-007 + Ipilimumab
n=18 participants at risk
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
18/18 • up to 50 months
|
|
General disorders
Fatigue
|
88.9%
16/18 • up to 50 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
88.9%
16/18 • up to 50 months
|
|
Nervous system disorders
Neuropathy
|
83.3%
15/18 • up to 50 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
77.8%
14/18 • up to 50 months
|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
14/18 • up to 50 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
72.2%
13/18 • up to 50 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
72.2%
13/18 • up to 50 months
|
|
General disorders
Pain
|
66.7%
12/18 • up to 50 months
|
|
Metabolism and nutrition disorders
Anorexia
|
61.1%
11/18 • up to 50 months
|
|
Gastrointestinal disorders
Nausea
|
61.1%
11/18 • up to 50 months
|
|
Investigations
Transaminitis
|
61.1%
11/18 • up to 50 months
|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
8/18 • up to 50 months
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
8/18 • up to 50 months
|
|
Gastrointestinal disorders
Constipation
|
38.9%
7/18 • up to 50 months
|
|
Nervous system disorders
Headache
|
38.9%
7/18 • up to 50 months
|
|
Cardiac disorders
Hypertension
|
27.8%
5/18 • up to 50 months
|
|
General disorders
Chills
|
22.2%
4/18 • up to 50 months
|
|
General disorders
Fever
|
16.7%
3/18 • up to 50 months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
3/18 • up to 50 months
|
|
Gastrointestinal disorders
Mucositis
|
16.7%
3/18 • up to 50 months
|
|
Investigations
Elevated Bilirubin
|
11.1%
2/18 • up to 50 months
|
|
Investigations
Elevated Creatinine
|
11.1%
2/18 • up to 50 months
|
|
Endocrine disorders
Hypophysitis
|
11.1%
2/18 • up to 50 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
2/18 • up to 50 months
|
Additional Information
Adi Diab, MD-Associate Professor, Melanoma Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 745-7336
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place