CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Aldesleukin +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02500576
NCT02500576Phase 2Completed

Phase II Study of MK-3475 in Conjunction With Lymphodepletion, TIL, and High or Low Dose IL-2 in Patients With Metastatic Melanoma

M.D. Anderson Cancer Center·interventional·Posted Jul 16, 2015·Updated Jan 15, 2025

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Cyclophosphamide, and 5 other interventions for Metastatic Melanoma and 3 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 16, 2015
Enrollment StartAug 7, 2015
Primary CompletionOct 12, 2022
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 11.0 years ago

Interventions

Aldesleukinbiological

Given IV or SC

Cyclophosphamidedrug

Given IV

Fludarabine Phosphatedrug

Given IVPB

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Therapeutic Tumor Infiltrating Lymphocytesbiological

Given IV