Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02500576 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma
A Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02500576: Completed Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
NCT02500576 is a Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02500576, a Phase 2 study of Metastatic Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase II trial studies how well giving pembrolizumab with standard chemotherapy, tumor infiltrating lymphocytes (TIL), and aldesleukin works in treating patients with melanoma that has spread to other areas of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving an infusion of TIL, or white blood cells, may help stimulate the immune system to help kill more cells. Aldesleukin may also stimulate the white blood cells to kill melanoma cells. Giving pembrolizumab together with standard chemotherapy, TIL, and high- or low-dose aldesleukin may help stop the melanoma from spreading.
Primary Outcome
The overall response rate will be computed separately by arm and presented with exact 95% confidence intervals. The overall response rate will be compared between the two treatment arms by using Fisher's exact test. The association between overall response rate and the same covariates will be assessed by using logistic regression.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- BIOLOGICAL Aldesleukin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-08-07 |
| Est. Completion | 2022-10-12 |
| Phase | Phase 2 |
What the finished NCT02500576 record still lists
NCT02500576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02500576 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02500576 about?
NCT02500576 is a clinical study titled "Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma". This randomized phase II trial studies how well giving pembrolizumab with standard chemotherapy, tumor infiltrating lymphocytes (TIL), and aldesleukin works in treating patients with melanoma that has spread to other areas of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab,...
What is the current status of trial NCT02500576?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2015-08-07. Estimated completion is 2022-10-12.
What conditions does trial NCT02500576 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT02500576?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Aldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT02500576?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02500576 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02500576's enrollment target sits among peer trials
18 71st of 91 higher than 18 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
RECRUITING · Phase 2
-
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
RECRUITING · Phase 2
-
Cryoablation+Ipilimumab+Nivolumab in Melanoma
RECRUITING · Phase 2
-
Mirdametinib in Patients With Advanced NF1-mutant Melanoma
RECRUITING · Phase 2
-
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
RECRUITING · Phase 2
-
Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI