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Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone

NCT02736123 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-09-20

No results posted yet for this study

Summary

This study plans to test the pathologic complete response (pCR) rate of the combination biotherapy regimen consisting of nivolumab plus ipilimumab versus nivolumab alone in patients with advanced but operable melanoma. Evaluation of the presence of tumor-infiltrating CD8+ T cells as well as that of PDL1 expression and IDO expression will be associated with clinical response (pathologic and/or radiologic). The study will test the radiologic/clinical preoperative response rate, recurrence free survival (RFS) and overall survival (OS). It will evaluate the safety of neoadjuvant nivolumab and neoadjuvant nivolumab-ipilimumab. Up to 66 patients will be randomized in 1:1 ratio.

Conditions

Interventions

DRUG

Nivolumab - Arm A

Nivolumab will be given during the induction phase of the study for 6 weeks. This is followed by surgery. Then maintenance therapy (after recovery from surgery).

DRUG

Nivolumab + Ipilimumab - Arm B

Nivolumab + ipilimumab during the induction phase of the study for 6 weeks. This is followed by surgery (week 6-8+). Then maintenance therapy will be initiated for up to one year from study drug initial administration ((after recovery from surgery).

Sponsors & Collaborators

Principal Investigators

  • Ahmad Tarhini, MD, PhD · 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
2016-10-31
Primary Completion
2017-02-09
Completion
2017-02-09

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02736123 on ClinicalTrials.gov