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NCT02506153 · ClinicalTrials.gov registry record · Phase 3

Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery

A Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
1,301
Enrollment target
20
Study locations

NCT02506153 is a Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 1,301 participants, above the 111-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (1072% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT02506153, a Phase 3 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,301 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.

Conditions Studied

Clinical Stage IV Cutaneous Melanoma AJCC v8 Clinical Stage III Cutaneous Melanoma AJCC v8 Metastatic Cutaneous Melanoma Metastatic Mucosal Melanoma Recurrent Cutaneous Melanoma Non-Cutaneous Melanoma Metastatic Non-Cutaneous Melanoma Recurrent Mucosal Melanoma Recurrent Non-Cutaneous Melanoma

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Ipilimumab

Study Locations (20)

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Sutter Auburn Faith Hospital - Auburn
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • UC Irvine Health Cancer Center-Newport - Costa Mesa
  • City of Hope Comprehensive Cancer Center - Duarte
  • Kaiser Permanente-Fontana - Fontana
  • Kaiser Permanente-Fremont - Fremont
  • Palo Alto Medical Foundation-Fremont - Fremont
  • Kaiser Permanente-Fresno - Fresno
  • Kaiser Permanente South Bay - Harbor City
  • Kaiser Permanente-Irvine - Irvine
  • UC San Diego Moores Cancer Center - La Jolla

Arizona

  • Cancer Center at Saint Joseph's - Phoenix
  • Virginia G Piper Cancer Care-Del Camino - Scottsdale
  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock
  • Highlands Oncology Group - Rogers - Rogers

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Trial Details

FieldValue
Enrollment Target 1,301 participants
Start Date 2015-11-10
Est. Completion 2027-01-23
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02506153

The ClinicalTrials.gov registry entry for NCT02506153 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,301 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 111-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (1072% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT02506153 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT02506153 about?

NCT02506153 is a clinical study titled "Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery". This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely t...

What is the current status of trial NCT02506153?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,301 participants. The study started on 2015-11-10. Estimated completion is 2027-01-23.

What conditions does trial NCT02506153 study?

This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma, Recurrent Cutaneous Melanoma.

What interventions are being tested in trial NCT02506153?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02506153?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02506153 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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