Trial Outcomes & Findings for Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma (NCT NCT01369875)

Last Updated: 2019-12-10

Results Overview

Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

up to approximately 8 months

Results posted on

2019-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Young TIL Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6	ECCE Young TIL Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: up to approximately 8 months

Outcome measures

Outcome measures
Measure	Standard Young TIL n=1 Participants Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6	ECCE Young TIL n=1 Participants Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6
Number of Participants With Clinical Tumor Regression. Complete Response	0 Participants	0 Participants
Number of Participants With Clinical Tumor Regression. Stable Disease	0 Participants	0 Participants
Number of Participants With Clinical Tumor Regression. Progression	1 Participants	1 Participants
Number of Participants With Clinical Tumor Regression. Partial Response	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, up to approximately 8 months.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Standard Young TIL n=1 Participants Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6	ECCE Young TIL n=1 Participants Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6
Number of Participants With Serious and Non-Serious Adverse Events	1 Participants	1 Participants

Adverse Events

Standard Young TIL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

ECCE Young TIL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Young TIL n=1 participants at risk Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6	ECCE Young TIL n=1 participants at risk Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6
Blood and lymphatic system disorders Hemoglobin	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
Blood and lymphatic system disorders Leukocytes (total WBC)	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
Blood and lymphatic system disorders Lymphopenia	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
Blood and lymphatic system disorders Platelets	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
General disorders Fatigue (asthenia, lethargy, malaise)	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
Skin and subcutaneous tissue disorders Hypopigmentation	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	0.00% 0/1 • Date treatment consent signed to date off study, up to approximately 8 months.
Infections and infestations Febrile neutropenia	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	0.00% 0/1 • Date treatment consent signed to date off study, up to approximately 8 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.	0.00% 0/1 • Date treatment consent signed to date off study, up to approximately 8 months.
Nervous system disorders Neuropathy: motor	0.00% 0/1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
General disorders Pain	0.00% 0/1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	0.00% 0/1 • Date treatment consent signed to date off study, up to approximately 8 months.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, up to approximately 8 months.

Additional Information

Dr. Steven Rosenberg

National Cancer Institute, National Institutes of Health

Phone: 301-496-4164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standard Young TIL n=1 Participants Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6	ECCE Young TIL n=1 Participants Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0 Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.) Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1) Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6	Total n=2 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50.0 years n=5 Participants	46.0 years n=7 Participants	48.0 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants