Trial Outcomes & Findings for CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (NCT NCT02027935)
NCT ID: NCT02027935
Last Updated: 2024-10-08
Results Overview
Evaluate the safety and efficacy of adoptively transferred CTL targeting melanoma tumors combined with anti-CTLA4
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline up to 2 years
Results posted on
2024-10-08
Participant Flow
A Phase II trial aimed at treating up to 20 HLA-A\*0201+ individuals with metastatic melanoma. A perfomance status of \>70% (85% of total patients, n-119) and HLA-A@ expression (40% of these patients), an average of 45 patients/year will be eligible for this study
16 subjects consented; 7 subjects treated
Participant milestones
| Measure |
Treatment (T Cells, Chemo, Aldesleukin, Ipilimumab)
Single dose of cytoxan at 300mg/m2 on Day-2; Day 0 infusion of 10\^10 T cells/2; 14-day course of low-dose s.c. IL-2; Anti-CTLA4 3 mg/kg IV over 90 minutes 24 hrs post T Cell infusion; Anti-CTLA4 q3 weeks 3 mg/kg IV for 4 doses.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Treatment (T Cells, Chemo, Aldesleukin, Ipilimumab)
Single dose of cytoxan at 300mg/m2 on Day-2; Day 0 infusion of 10\^10 T cells/2; 14-day course of low-dose s.c. IL-2; Anti-CTLA4 3 mg/kg IV over 90 minutes 24 hrs post T Cell infusion; Anti-CTLA4 q3 weeks 3 mg/kg IV for 4 doses.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Study Closure
|
1
|
Baseline Characteristics
CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (T Cells, Chemo, Aldesleukin, Ipilimumab)
n=7 Participants
Single dose of cytoxan at 300mg/m2 on Day-2; Day 0 infusion of 10\^10 T cells/2; 14-day course of low-dose s.c. IL-2; Anti-CTLA4 3 mg/kg IV over 90 minutes 24 hrs post T Cell infusion; Anti-CTLA4 q3 weeks 3 mg/kg IV for 4 doses.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 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
|
6 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
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data was not collected
Evaluate the safety and efficacy of adoptively transferred CTL targeting melanoma tumors combined with anti-CTLA4
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Data was not collected
Evaluate the influence of anti-CTLA4 on the duration of in vivo persistence and anti-tumor efficacy achieved following adooptive transfer of antigen-specific CTL.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (T Cells, Chemo, Aldesleukin, Ipilimumab)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (T Cells, Chemo, Aldesleukin, Ipilimumab)
n=7 participants at risk
Single dose of cytoxan at 300mg/m2 on Day-2; Day 0 infusion of 10\^10 T cells/2; 14-day course of low-dose s.c. IL-2; Anti-CTLA4 3 mg/kg IV over 90 minutes 24 hrs post T Cell infusion; Anti-CTLA4 q3 weeks 3 mg/kg IV for 4 doses.
|
|---|---|
|
Nervous system disorders
Intracranial hemorrhage
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Investigations
Hyponatremia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Cardiac disorders
Hypotention
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Death NOS
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Lymphedema
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
Other adverse events
| Measure |
Treatment (T Cells, Chemo, Aldesleukin, Ipilimumab)
n=7 participants at risk
Single dose of cytoxan at 300mg/m2 on Day-2; Day 0 infusion of 10\^10 T cells/2; 14-day course of low-dose s.c. IL-2; Anti-CTLA4 3 mg/kg IV over 90 minutes 24 hrs post T Cell infusion; Anti-CTLA4 q3 weeks 3 mg/kg IV for 4 doses.
|
|---|---|
|
Investigations
Creatinine increased
|
42.9%
3/7 • Number of events 4 • Baseline up to 2 years
CTCAE v4.0
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Number of events 8 • Baseline up to 2 years
CTCAE v4.0
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
42.9%
3/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Endocrine disorders
Endocrine disorders
|
14.3%
1/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Eye disorders
Eye disorders
|
28.6%
2/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Eye disorders
Eye pain
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 14 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Fever
|
42.9%
3/7 • Number of events 10 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Gastrointestinal disordedrs
|
28.6%
2/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
General disorders
|
42.9%
3/7 • Number of events 5 • Baseline up to 2 years
CTCAE v4.0
|
|
Nervous system disorders
Headache
|
71.4%
5/7 • Number of events 8 • Baseline up to 2 years
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Vascular disorders
Hot Flashes
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 4 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
42.9%
3/7 • Number of events 7 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
4/7 • Number of events 13 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Number of events 4 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Number of events 9 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Vascular disorders
Hypothyrodism
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
General disorders
Injection site reaction
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Vascular disorders
Lymphedema
|
28.6%
2/7 • Number of events 4 • Baseline up to 2 years
CTCAE v4.0
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limbs
|
28.6%
2/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
28.6%
2/7 • Number of events 4 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Number of events 7 • Baseline up to 2 years
CTCAE v4.0
|
|
Cardiac disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Pain
|
57.1%
4/7 • Number of events 7 • Baseline up to 2 years
CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
28.6%
2/7 • Number of events 2 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
2/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Psychiatric disorders
Psychiatric disorders
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
57.1%
4/7 • Number of events 5 • Baseline up to 2 years
CTCAE v4.0
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
14.3%
1/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
42.9%
3/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Renal and urinary disorders
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 3 • Baseline up to 2 years
CTCAE v4.0
|
|
Eye disorders
Watery Eyes
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
|
Investigations
Weight Loss
|
14.3%
1/7 • Number of events 1 • Baseline up to 2 years
CTCAE v4.0
|
Additional Information
Dr. Adi Diab
University of Texas 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