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Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma

NCT01608594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and potential effectiveness of a new treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better understand this disease, how best to treat it and what patients should be treated with this combination.

Conditions

Interventions

DRUG

administration of ipilimumab10mg/kg

Ipilimumab IV infusion: * Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery * After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart * Dose continued 12 weeks later for 4 additional doses given 12 weeks apart Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks.

DRUG

administration of ipilimumab 3mg/kg + HDI

Ipilimumab IV infusion: * Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery * After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart * Dose continued 12 weeks later for 4 additional doses given 12 weeks apart Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks.

Sponsors & Collaborators

  • Diwakar Davar

    lead OTHER

Principal Investigators

  • Diwakar Davar, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-21
Primary Completion
2017-02-14
Completion
2017-02-27

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 NCT01608594 on ClinicalTrials.gov