Trial Outcomes & Findings for Ipilimumab + Temozolomide in Metastatic Melanoma (NCT NCT01119508)
NCT ID: NCT01119508
Last Updated: 2024-06-06
Results Overview
6-month progression free survival rate is defined as the number of participants without progression per RECIST 1.0 6 months after starting study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
6 Months
Results posted on
2024-06-06
Participant Flow
Recruitment period: May 26, 2010 to August 29, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Ipilimumab + Temozolomide
Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
Received Four Induction Doses
|
45
|
|
Overall Study
Received Fifth Consolidation Dose week12
|
32
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
Ipilimumab + Temozolomide
Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
56
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Died before tumor response evaluation
|
1
|
Baseline Characteristics
Ipilimumab + Temozolomide in Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Ipilimumab + Temozolomide
n=64 Participants
Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
|
|---|---|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
|
Age, Continuous
|
62 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 Months6-month progression free survival rate is defined as the number of participants without progression per RECIST 1.0 6 months after starting study treatment.
Outcome measures
| Measure |
Ipilimumab + Temozolomide
n=64 Participants
Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
|
|---|---|
|
6-Month Progression-Free Survival (PFS) Rate
|
29 participants
|
Adverse Events
Ipilimumab + Temozolomide
Serious events: 59 serious events
Other events: 64 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ipilimumab + Temozolomide
n=64 participants at risk
Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.2%
4/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
10.9%
7/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
General disorders
Fatigue
|
15.6%
10/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
6/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Anorexia
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
General disorders
Pain
|
7.8%
5/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
3/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
3/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
4/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.7%
3/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
ALT (high)
|
4.7%
3/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
AST (high)
|
4.7%
3/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Alk Phos (high)
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Total Bilirubin (high)
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Magnesium (low)
|
1.6%
1/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
Other adverse events
| Measure |
Ipilimumab + Temozolomide
n=64 participants at risk
Induction: Ipilimumab 10 mg/kg intravenous (IV) over 90 minutes Day 1 repeated every 3 weeks until 4 courses of therapy are given over 3 months + Temozolomide 200 mg/m2 orally Days 1 to 4; both repeated every 3 weeks for 4 courses over 3 months. For Maintenance Phase, Ipilimumab repeated every 12 weeks, Temozolomide Days 1 to 5 repeated every 4 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
81.2%
52/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
71.9%
46/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
General disorders
Fatigue
|
62.5%
40/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
48/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Constipation
|
68.8%
44/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Diarrhea
|
46.9%
30/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Vomiting
|
51.6%
33/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
32/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
51.6%
33/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Nervous system disorders
Headache
|
50.0%
32/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
28.1%
18/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
General disorders
Fever
|
32.8%
21/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
16/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Gastrointestinal disorders
Colitis
|
9.4%
6/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Anemia
|
65.6%
42/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
3/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
21.9%
14/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.2%
20/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
64.1%
41/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
ALT (high)
|
40.6%
26/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
AST (high)
|
37.5%
24/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Alk Phos (high)
|
23.4%
15/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Total Bilrubin (high)
|
14.1%
9/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Magnesium (low)
|
25.0%
16/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Creatinine (high)
|
25.0%
16/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
|
Metabolism and nutrition disorders
Potassium (low)
|
14.1%
9/64 • Adverse Events collected till 30 days after the last dose of drug, approximate total of 7 weeks for Induction and Maintenance periods.
|
Additional Information
Dr. Sapna P. Patel, Assistant Professor, Melanoma Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place