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A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

NCT03999749 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-03-09

Study results available
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Summary

This is a Phase II, open-label, single arm study. The study will consist of an assessment of the safety and tolerability of tocilizumab administered concurrently at 4 mg/kg every 6 weeks for 5 doses in combination with ipilimumab and nivolumab for four induction doses to week 12, then maintenance nivolumab alone up to one year to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will inform the use of this 3-drug combination for further phase II and/or phase III clinical testing. The trial will include an assessment of the pharmacodynamic activity of tocilizumab administered in combination with ipilimumab and nivolumab.

Conditions

Interventions

DRUG

Ipilimumab

4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval

DRUG

Nivolumab

Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years

DRUG

Tocilizumab

Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg

Sponsors & Collaborators

Principal Investigators

  • Janice Mehnert, MD · New York Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2023-07-01
Completion
2030-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03999749 on ClinicalTrials.gov