MedTrace Logo

Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

NCT03528408 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-04-11

No results posted yet for this study

Summary

This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab

Conditions

Interventions

DRUG

Nivolumab

Nivolumab 240 mg IV over 30 minutes given Day 1, 15 and 29 of each Cycle

DRUG

Ipilimumab

Ipilimumab 1 mg/kg IV over 60 minutes given Day 1 of each Cycle

Sponsors & Collaborators

Principal Investigators

  • Suthee Rapisuwon, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2023-05-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03528408 on ClinicalTrials.gov