Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone

Melanoma Clinical Trial

Official title: Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone in Patients With Locally/Regionally Advanced/Recurrent Melanoma: A Randomized Efficacy, Safety and Biomarker Study

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

The study has 2 study arms:

• Nivolumab alone (Arm A)

• Induction phase: nivolumab 3 mg/kg IV infusion every 2 weeks x3 doses. Followed by Definitive Surgery.

• Maintenance phase: nivolumab 3 mg/kg IV infusion every 3 weeks for up to one year from study treatment initiation.

• Ipilimumab + nivolumab (Arm B)

• Induction phase: Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV every 3 weeks x2. Followed by Definitive Surgery.

• Maintenance phase: nivolumab 3 mg/kg IV infusion every 2 weeks for up to one year from study treatment initiation.

Definitive Surgery consists of complete lymph node dissection/ lymphatic, cutaneous, subcutaneous or other distant disease resection (week 6-8+). ;

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT02736123
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: October 2016
• Completion date: February 9, 2017