MedTrace Logo

A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study

NCT02796352 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-04-20

Study results available
· View outcomes & findings →

Summary

This study is for patients with advanced stage III or stage IV melanoma not adequately treated by surgery who have progressed after treatment with nivolumab or pembrolizumab. The purpose of this study is to see if giving high dose interleukin-2 (IL-2) after progression on nivolumab or pembrolizumab is effective in treating metastatic melanoma. This study is also being done to look at the severity of side effects of IL-2 in patients.

IL-2 is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma.

Conditions

Interventions

DRUG

High dose bolus interleukin-2 (HD IL2)

Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle). The planned treatment consists of 3 courses (6 cycles) of HD IL-2.

Sponsors & Collaborators

  • Prometheus Laboratories

    collaborator INDUSTRY

  • Ahmad Tarhini

    lead OTHER

Principal Investigators

  • Ahmad Tarhini, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-02-16
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796352 on ClinicalTrials.gov