Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma
NCT02626962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2022-03-22
Summary
This is a Phase 2, single-arm study of nivolumab combined with ipilimumab in subjects with previously untreated, unresectable or metastatic uveal melanoma. Previous studies with immunotherapy have shown promising results and this synergistic combination was very effective in other tumors. This study will allow for further characterization of the safety and clinical activity of nivolumab combined with ipilimumab in subjects with uveal melanoma.
Conditions
Interventions
- DRUG
-
Ipilimumab every 3 weeks for a total of four doses (Cycles 1 and 2)
- DRUG
-
Nivolumab every 3 weeks for a total of four doses (Cycles 1 and 2) followed by Nivolumab every 2 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
Grupo Español Multidisciplinar de Melanoma
lead OTHER
Principal Investigators
-
Josep Maria Piulats, MD · ICO Hospitalet
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2017-05-31
- Completion
- 2021-07-22
Countries
- Spain
Study Locations
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