Trial · NCT01369888
Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma
NCT01369888, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma. Trials, record NCT01369888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369888
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma
- NCT number
- NCT01369888
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Melanoma, Skin Cancer
- Interventions
- Cyclophosphamide, Fludarabine, Tumor Infiltrating Lymphocytes, IL-15
- First posted
- 2011-06-09
- Last updated
- 2015-01-27
- Results first posted
- 2015-01-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL. | 2 years | Intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL with dose escalation (i.e., dose level 1: 0.25 mcg, dose level 2: 0.50 mcg, dose level 3: 1 mcg, and dose level 4: 2 mcg) to further characterize the safety of the MTD prior to starting the phase 2 portion. |
| Primary | Number of Participants With Adverse Events | 8 months, 9 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL. | 2 years | mcg/kg/day | NUMBER | |
| PRIMARY | Number of Participants With Adverse Events | 8 months, 9 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL. | IL-15 Following Young TIL (0.25 mcg) | NA | mcg/kg/day | ||
Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL. | IL-15 Following Young TIL (0.50 mcg) | NA | mcg/kg/day | ||
| Number of Participants With Adverse Events | IL-15 Following Young TIL (0.25 mcg) | 1 | participants | ||
| Number of Participants With Adverse Events | IL-15 Following Young TIL (0.50 mcg) | 2 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IL-15 Following Young TIL (0.25 mcg) | 1 | |
| Overall Study | STARTED | IL-15 Following Young TIL (0.50 mcg) | 2 | |
| Overall Study | STARTED | IL-15 Following Young TIL (1 mcg) | 0 | |
| Overall Study | STARTED | IL-15 Following Young TIL (2 mcg) | 0 | |
| Overall Study | COMPLETED | IL-15 Following Young TIL (0.25 mcg) | 1 | |
| Overall Study | COMPLETED | IL-15 Following Young TIL (0.50 mcg) | 2 | |
| Overall Study | COMPLETED | IL-15 Following Young TIL (1 mcg) | 0 | |
| Overall Study | COMPLETED | IL-15 Following Young TIL (2 mcg) | 0 | |
| Overall Study | NOT COMPLETED | IL-15 Following Young TIL (0.25 mcg) | 0 | |
| Overall Study | NOT COMPLETED | IL-15 Following Young TIL (0.50 mcg) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 | Leukocytes (total WBC) | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 | 1 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.50 mcg) | 2 | 2 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.50 mcg) | 2 | 2 | 2 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 | 1 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.50 mcg) | 2 | 2 | 2 |
| other | Platelets | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 | 1 |
| other | Platelets | Blood and lymphatic system disorders | IL-15 Following Young TIL (0.50 mcg) | 2 | 2 | 2 |
| other | Mucositis/stomatitis | Gastrointestinal disorders | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 | 1 |
| other | Mucositis/stomatitis | Gastrointestinal disorders | IL-15 Following Young TIL (0.50 mcg) | 0 | 2 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IL-15 Following Young TIL (0.25 mcg) | ||
| Total, all-cause mortality | IL-15 Following Young TIL (0.50 mcg) | ||
| Total, other adverse events | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 |
| Total, other adverse events | IL-15 Following Young TIL (0.50 mcg) | 2 | 2 |
| Total, serious adverse events | IL-15 Following Young TIL (0.25 mcg) | 1 | 1 |
| Total, serious adverse events | IL-15 Following Young TIL (0.50 mcg) | 0 | 2 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IL-15 Following Young TIL (0.25 mcg) vs IL-15 Following Young TIL (0.50 mcg): Number of Participants With Adverse Events | Trial comparisons |
| IL-15 Following Young TIL (0.25 mcg) vs IL-15 Following Young TIL (0.50 mcg): serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01369888
GET https://conductscience.org/api/trials/v1/NCT01369888/events?page=2