NCT01993719 is a Phase 2 clinical trial of Aldesleukin in Metastatic Melanoma, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT01993719?

NCT01993719 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01993719?

Interventions in NCT01993719: Aldesleukin, Fludarabine, Fludarabine, Cyclophosphamide, Cyclophosphamide, Cyclophosphamide, Young TIL, Pembrolizumab.

What condition does NCT01993719 study?

NCT01993719 studies Metastatic Melanoma.

Is NCT01993719 still recruiting?

NCT01993719 is currently completed. Last updated 18 January 2023.

Are results published for NCT01993719?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-18 · How we verify

NCT01993719

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

Completed Phase 2 Results posted Last updated 18 January 2023

What this trial tests

Phase 2 trial testing Aldesleukin in Metastatic Melanoma in 33 participants. Completed in 6 July 2022.

Timeline

12 December 2013

Primary endpoint
14 October 2021

6 July 2022

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	12 December 2013
Primary completion	14 October 2021
Estimated completion	6 July 2022
Sites	1 location across United States

Drugs / interventions tested

Aldesleukin (ALDESLEUKIN) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Young TIL
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 70, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P Primary · 30 days after end of treatment

Number of participants with Grades 3-5 treatment-related adverse events were compared in Arm 1N and Arm 1P; and adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe. Grade 4 is life-threatening, and Grade 5 is death related to adverse event.

ALT, SGPT (serum glutamic pyruvic transaminase)

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	2
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	1
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

AST, SGOT(serum glutamic oxaloacetic transaminase)

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	1
Grade 3 - Probably Related Arm 2, Arm 2/1P	1
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Allergic reaction/hypersensitivity (including drug fever)

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	0
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Bilirubin (hyperbilirubinemia)

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	0
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Confusion

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	0
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Creatinine

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	3
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	0
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Diarrhea

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	1
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	0
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Febrile neutropenia

Group	Value	95% CI
Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	3
Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	4
Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	2
Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P	0
Grade 3 - Possibly Related Arm 2, Arm 2/1P	0
Grade 3 - Probably Related Arm 2, Arm 2/1P	0
Grade 3 - Definitely Related Arm 2, Arm 2/1P	0
Grade 4 - Possibly Related Arm 2, Arm 2/1P	0
Grade 4 - Probably Related Arm 2, Arm 2/1P	0

Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) Primary · 4 weeks after cell infusion, then every 3 months x 3 and then every 6 months for 5 years, then per Principal Investigator (PI) discretion up to 5 years or disease progression

Clinical response to treatment was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST v1.0). 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. Progressive Disease (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 P

First Treatment - Complete Response

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	0
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	0
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA

First Treatment - Partial Response

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA

First Treatment - Progressive Disease

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	8
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	0
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA

First Treatment - Stable Disease

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	3
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA

Second Treatment - Complete Response

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	0
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	0

Second Treatment - Partial Response

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1

Second Treatment - Progressive Disease

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1

Second Treatment - Stable Disease

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	0

Overall Response Rate (ORR) Primary · Date of cells until time of disease progression, up to approximately 67.2 months.

Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression 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.

Initial Treatment

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	23.10	8.2 – 50.3
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	57.10	25 – 84.1
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	16.70	3 – 44.8

Retreat

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	33.30	1.7 – 88.2
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	50	2.6 – 97.4

Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab Secondary · Date treatment consent signed until approximately 4 weeks following last dose of Pembrolizumab, up to 4 weeks

Number of treatment-related adverse events for participants who received pembrolizumab. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Group	Value	95% CI
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	16

Progression-free Survival (PFS) Secondary · Date of cells until time of disease progression up to approximately 67.2 months.

PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (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.

Initial Treatment

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	3.1	1.3 – 14.6
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	7.9	2 – NA
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2.1	0.9 – 12.8

Retreat

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	1.6	0.1 – 5.3
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	32.5	2.3 – NA

Overall Survival Secondary · Date of cells until time to death, up until 90.1 months.

Overall survival is defined as the time from treatment start date until date of death, or date last known alive.

Group	Value	95% CI
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	14.3	2.3 – NA
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	NA	18.7 – NA
Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	15.1	5.4 – NA

Overall Survival Secondary · An average of 25.6 months.

Overall survival is defined as the time from treatment start date until date of death, or date last known alive.

Group	Value	95% CI
All Participants in Arms 1N, 1P, Arm 2/Foll By Arm 1P, Arm 2, and Arm 1P/Foll By Arm 1P/R	17.5	2.3 – NA

Overall Progression Free Survival (PFS) Secondary · Time to progression and time to death, approximately up to 67.2 months.

PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (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.

Group	Value	95% CI
All Participants in Arms 1N, 1P, Arm 2/Foll By Arm 1P, Arm 2, and Arm 1P/Foll By Arm 1P/R	3	0.9 – NA

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) Secondary · Date treatment consent signed to date off study, approximately 102 months and 9 days, 92 months and 19 days, 86 months and 9 days, 99 months and 16 days, and 86 months and 26 days for each group respectively.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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

Group	Value	95% CI
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	7
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	9
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	3
Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	9
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Date treatment consent signed to date off study, approximately 102 months and 9 days, 92 months and 19 days, 86 months and 9 days, 99 months and 16 days, and 86 months and 26 days for each group respectively.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin

Serious: 3/7 (43%)

Deaths: 2/7

Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin

Serious: 6/11 (55%)

Deaths: 9/11

Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin

Serious: 1/3 (33%)

Deaths: 2/3

Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin

Serious: 2/9 (22%)

Deaths: 8/9

Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin

Serious: 1/2 (50%)

Deaths: 1/2

Serious adverse events (18 terms)

Reaction	System	Arm 1N -Standard Chemother…	Arm 1P - Standard Chemothe…	Arm 2/Foll By Arm 1P-Low D…	Arm 2- Low Dose Chemothera…	Arm 1P/Foll By Arm-1P/R-St…
Infection	Infections and infestations	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Hemoglobin	Investigations	—	—	—	—	—
ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	—	—	—	—	—
AST, SGOT(serum glutamic oxaloacetic transaminase)	Investigations	—	—	—	—	—
Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	—	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Left ventricular systolic dysfunction	Cardiac disorders	—	—	—	—	—
Lymphopenia	Investigations	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—
Neutrophils/granulocytes (ANC/AGC)	Investigations	—	—	—	—	—
Platelets	Investigations	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Weight loss	Investigations	—	—	—	—	—

Other adverse events (43 terms — click to expand)

Reaction	System	Arm 1N -Standard Chemother…	Arm 1P - Standard Chemothe…	Arm 2/Foll By Arm 1P-Low D…	Arm 2- Low Dose Chemothera…	Arm 1P/Foll By Arm-1P/R-St…
Lymphopenia	Investigations	—	—	—	—	—
Neutrophils/granulocytes (ANC/AGC)	Investigations	—	—	—	—	—
Platelets	Investigations	—	—	—	—	—
Fatigue (asthenia, lethargy, malaise)	General disorders	—	—	—	—	—
Hemoglobin	Investigations	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Creatinine	Investigations	—	—	—	—	—
PTT (Partial Thromboplastin Time)	Investigations	—	—	—	—	—
Psychosis (hallucinations/delusions)	Psychiatric disorders	—	—	—	—	—
ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	—	—	—	—	—
AST, SGOT(serum glutamic oxaloacetic transaminase)	Investigations	—	—	—	—	—
Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—
Bilirubin (hyperbilirubinemia)	Investigations	—	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	General disorders	—	—	—	—	—
Hemorrhage, GU::Vagina	Reproductive system and breast disorders	—	—	—	—	—
Hypopigmentation	Skin and subcutaneous tissue disorders	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—
Leukocytes (total WBC)	Investigations	—	—	—	—	—
Mood alteration::Agitation	Psychiatric disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Pain::Head/headache	Nervous system disorders	—	—	—	—	—
Pain::Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Phosphate, serum-low (hypophosphatemia)	Metabolism and nutrition disorders	—	—	—	—	—
Pruritus/itching	Skin and subcutaneous tissue disorders	—	—	—	—	—
Rash/desquamation	Skin and subcutaneous tissue disorders	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—
Renal/Genitourinary - Other (oliguria)	Renal and urinary disorders	—	—	—	—	—
Rigors/chills	General disorders	—	—	—	—	—
Supraventricular and nodal arrhythmia::Sinus tachycardia	Cardiac disorders	—	—	—	—	—
Thrombosis/thrombus/embolism	Vascular disorders	—	—	—	—	—
Thyroid function, low (hypothyroidism)	Endocrine disorders	—	—	—	—	—
Uric acid, serum-high (hyperuricemia)	Metabolism and nutrition disorders	—	—	—	—	—
Uveitis	Eye disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—

Most-reported serious reactions: Infection, Febrile neutropenia, Hemoglobin, ALT, SGPT (serum glutamic pyruvic transaminase), AST, SGOT(serum glutamic oxaloacetic transaminase), Allergic reaction/hypersensitivity (including drug fever), Confusion, Hypotension.

Data from ClinicalTrials.gov NCT01993719 adverse events section.

Sponsor's own description

Background: * The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with melanoma. * In this trial, we are determining if there is a difference in the response between patients who have received prior anti-programmed cell death-1 (PD-1) treatment to those who have not received this prior ant-PD1 treatment. Objectives: \- To determine if there is a difference in the rate of response between patients who have received prior anti-PD1 and those who have not. Eligibility: \- Individuals at least 18 years and less than or equal to 70 years of age who have metastatic melanoma. Design: * Work up stage: Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white blood cells. White blood cells will be grown from the tumor in the laboratory. * Leukapheresis: Participants will have leukapheresis to collect additional white blood cells. (Leukapheresis is a common procedure which removes only the white blood cells from the patient.) * Treatment: Participants will receive standard dose chemotherapy to prepare their immune system to accept the white blood cells. Participants will receive an infusion of their own white blood cells grown from tumor. They will also receive aldesleukin for up to five days to boost the immune system s response to the white blood cells. They will stay in the hospital for about 4 weeks for the treatment. * Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Adoptive transfer of tumor-infiltrating lymphocytes in melanoma: a viable treatment option.
Rohaan MW, van den Berg JH, Kvistborg P, Haanen JBAG. · · 2018 · cited 147× · PMID 30285902 · DOI 10.1186/s40425-018-0391-1
Trial Watch: Chemotherapy with immunogenic cell death inducers.
Vacchelli E, Aranda F, Eggermont A, Galon J, et al · · 2014 · cited 123× · PMID 24800173 · DOI 10.4161/onci.27878
Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges.
Zhao Y, Deng J, Rao S, Guo S, et al · · 2022 · cited 114× · PMID 36077696 · DOI 10.3390/cancers14174160
Impact of Prior Treatment on the Efficacy of Adoptive Transfer of Tumor-Infiltrating Lymphocytes in Patients with Metastatic Melanoma.
Seitter SJ, Sherry RM, Yang JC, Robbins PF, et al · · 2021 · cited 89× · PMID 34413159 · DOI 10.1158/1078-0432.ccr-21-1171
Adoptive cell therapy in combination with checkpoint inhibitors in ovarian cancer.
Kverneland AH, Pedersen M, Westergaard MCW, Nielsen M, et al · · 2020 · cited 84× · PMID 32547707 · DOI 10.18632/oncotarget.27604
Neoantigen Identification and Response to Adoptive Cell Transfer in Anti-PD-1 Naïve and Experienced Patients with Metastatic Melanoma.
Levi ST, Copeland AR, Nah S, Crystal JS, et al · · 2022 · cited 51× · PMID 35247926 · DOI 10.1158/1078-0432.ccr-21-4499
The Challenging Melanoma Landscape: From Early Drug Discovery to Clinical Approval.
Matias M, Pinho JO, Penetra MJ, Campos G, et al · · 2021 · cited 34× · PMID 34831311 · DOI 10.3390/cells10113088
Retrospective Analysis of Adoptive TIL Therapy plus Anti-PD1 Therapy in Patients with Chemotherapy-Resistant Metastatic Osteosarcoma.
Zhou X, Wu J, Duan C, Liu Y. · · 2020 · cited 30× · PMID 33062726 · DOI 10.1155/2020/7890985

Verify or expand the search:

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Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01993719 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 18 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01993719.

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