Trial Outcomes & Findings for T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Melanoma (NCT NCT02062359)

NCT ID: NCT02062359

Last Updated: 2016-06-24

Results Overview

Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is 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 the 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 references the smallest sum LD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

3 months

Results posted on

2016-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin. On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes. Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: On days
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=2 Participants Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin. On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes. Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: On days
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	0 Participants n=5 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	2 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	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: None of the participants achieved a complete response or partial response and no data were collected for this assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 22 subjects was needed to perform an analysis.

Estimate the persistence of cells via enzyme linked immunosorbent spot (ELISPOT) and tetramer analysis by fluorescence activated cell sorting (FACS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.

Outcome measures

Outcome measures
Measure	All Participants n=2 Participants Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin. On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes. Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: On days
Number of Participants With Adverse Events	2 participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=2 participants at risk Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin. On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes. Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr. Fludarabine: On days
Cardiac disorders Hypotension	50.0% 1/2 • Number of events 1
Infections and infestations Febrile neutropenia	50.0% 1/2 • Number of events 1
Infections and infestations Blood infection	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders Decreased hemoglobin	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders Lymphopenia	100.0% 2/2 • Number of events 2
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	100.0% 2/2 • Number of events 2
Blood and lymphatic system disorders Decreased platelet count	100.0% 2/2 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	50.0% 1/2 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 2/2 • Number of events 2

Additional Information

Dr. Steven Rosenberg

National Cancer Institute

Phone: 301-496-4164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place