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Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

NCT02748564 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-03

Study results available
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Summary

This study will evaluate the safety and tolerability of IL-2 when given in combination with pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more tumor cells.

There are two parts to this study:

* Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in combination with pembrolizumab
* Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients will be treated to determine if it is effective against the cancer.

Conditions

  • Metastatic Melanoma
  • Stage III Mucosal Melanoma of the Head and Neck
  • Stage IIIA Skin Melanoma
  • Stage IIIB Skin Melanoma
  • Stage IIIC Skin Melanoma
  • Stage IV Skin Melanoma
  • Stage IVA Mucosal Melanoma of the Head and Neck
  • Stage IVB Mucosal Melanoma of the Head and Neck
  • Stage IVC Mucosal Melanoma of the Head and Neck

Interventions

BIOLOGICAL

Aldesleukin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Adam Berger, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2018-10-18
Completion
2023-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02748564 on ClinicalTrials.gov