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Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

NCT03241186 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-12-09

No results posted yet for this study

Summary

This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.

Conditions

  • Mucosal Melanoma

Interventions

DRUG

Ipilimumab

1mg/kg

DRUG

Nivolumab

3mg/kg

DRUG

Nivolumab

480mg

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Robert R. McWilliams, MD

    lead OTHER

Principal Investigators

  • Robert R. McWilliams, MD · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2022-09-15
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03241186 on ClinicalTrials.gov