Trial · NCT01993719
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
NCT01993719, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma. Trials, record NCT01993719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01993719
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
- NCT number
- NCT01993719
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Melanoma
- Interventions
- Aldesleukin, Fludarabine, Fludarabine, Cyclophosphamide, Cyclophosphamide, Cyclophosphamide, Young TIL, Pembrolizumab
- First posted
- 2013-11-25
- Last updated
- 2023-01-18
- Results first posted
- 2023-01-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | 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. |
| Primary | Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | 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 PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. |
| Primary | Overall Response Rate (ORR) | 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. |
| Secondary | Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab | 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. |
| Secondary | Progression-free Survival (PFS) | 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. |
| Secondary | Overall Survival | 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. |
| Secondary | Overall Survival | 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. |
| Secondary | Overall Progression Free Survival (PFS) | 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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 one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | 30 days after end of treatment | One participant was not treated on Arm 1N. Pre-specified by the protocol, there are two combined reporting groups for this outcome. The first combined group (n=23) is all who received standard chemo (Arm 1N, Arm 1P, the retreatment of Arm 2/1P, and the initial treatment of Arm 1P/R). The second combined group (n=12) is all who received the reduced dose chemo (Arm 2, and the initial treatment of Arm 2/1P) This separates reporting of adverse events by the intensity of chemotherapy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | 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 | The first combined group (n=16) is Arm 1P, the second treatment of Arm 2/1P, the initial treatment of Arm 1P/R. The second group (n=7) is Arm 1N (1/8 participants was not treated). The third group (n=12) is Arm 2 and the initial treatment of Arm 2/1P. The final group (n=2) will report the second treatment of Arm 1P/R. This enables reporting of the 37 treatments among the 32 treated participants separated by exposure to pembrolizumab/nivolumab and chemo dose. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate (ORR) | Date of cells until time of disease progression, up to approximately 67.2 months. | Retreat Arm 1N and Arm 2 Foll By Arm 1P not treated. | percentage of participants | NUMBER |
| SECONDARY | Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab | Date treatment consent signed until approximately 4 weeks following last dose of Pembrolizumab, up to 4 weeks | Adverse events | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Date of cells until time of disease progression up to approximately 67.2 months. | The first combined group (n=16) is Arm 1P, the second treatment of Arm 2/1P, the initial treatment of Arm 1P/R. The second group (n=7) is Arm 1N (1/8 participants was not treated). The third group (n=12) is Arm 2 and the initial treatment of Arm 2/1P. The final group (n=2) will report the second treatment of Arm 1P/R. This enables reporting of the 37 treatments among the 32 treated participants separated by exposure to pembrolizumab/nivolumab and chemo dose. 0 participants analyzed= not treated. | Months | MEDIAN |
| SECONDARY | Overall Survival | Date of cells until time to death, up until 90.1 months. | As pre-specified by the protocol, participants will be reported by the initial treatment arm: Arm 1N (n=7; 1/8 participants were not treated), Arm 1P (n=13), Arm 2 (n=12). | Months | MEDIAN |
| SECONDARY | Overall Survival | An average of 25.6 months. | 1/8 participants were not treated in Arm 1N. | Months | MEDIAN |
| SECONDARY | Overall Progression Free Survival (PFS) | Time to progression and time to death, approximately up to 67.2 months. | 1/8 participants were not treated in Arm 1N. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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. | 1/8 participants were not treated on Arm 1N. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group417
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 3 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 3 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 3 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 4 - Possibly Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 4 - Probably Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 4 - Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 5 - Possibly, Probably and/or Definitely Related Arm 1N, Arm 1P, Arm 2/1P, Arm 1/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 3 - Possibly Related Arm 2, Arm 2/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 1 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 3 - Probably Related Arm 2, Arm 2/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants | |
| Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P | Grade 3 - Definitely Related Arm 2, Arm 2/1P | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 | Participants |
1 to 10 of 417Source ClinicalTrials.gov
See all 417 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Drug Administration | STARTED | Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 8 | |
| First Drug Administration | STARTED | Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 11 | |
| First Drug Administration | STARTED | Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 3 | |
| First Drug Administration | STARTED | Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 | |
| First Drug Administration | STARTED | Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 | |
| First Drug Administration | COMPLETED | Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 7 | |
| First Drug Administration | COMPLETED | Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 11 | |
| First Drug Administration | COMPLETED | Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 3 | |
| First Drug Administration | COMPLETED | Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 | |
| First Drug Administration | COMPLETED | Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events305
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 1 | 7 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 1 | 11 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 3 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 9 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 2 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 1 | 7 | 1 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 11 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 3 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 1 | 9 | 1 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 0 | 2 | 0 |
1 to 10 of 305Source ClinicalTrials.gov
See all 305 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 | 7 |
| Total, all-cause mortality | Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 | 11 |
| Total, all-cause mortality | Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 | 3 |
| Total, all-cause mortality | Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 8 | 9 |
| Total, all-cause mortality | Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 1 | 2 |
| Total, other adverse events | Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 7 | 7 |
| Total, other adverse events | Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 | 11 |
| Total, other adverse events | Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 3 | 3 |
| Total, other adverse events | Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 9 | 9 |
| Total, other adverse events | Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin | 2 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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