Trials / Completed
CompletedNCT01585194
Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma
Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with uveal melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed description
PRIMARY OBJECTIVES: I. Overall response rate. SECONDARY OBJECTIVES: I. Progression-free survival. II. Median overall survival. III. One-year overall survival. EXPLORATORY OBJECTIVES: I. Tissue and blood correlates to define immune infiltration and signatures as a result of treatment with nivolumab plus ipilimumab. OUTLINE: INDUCTION PHASE: Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 60 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ipilimumab | Given IV |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| BIOLOGICAL | Nivolumab | Given IV |
Timeline
- Start date
- 2012-11-29
- Primary completion
- 2019-12-02
- Completion
- 2024-05-14
- First posted
- 2012-04-25
- Last updated
- 2024-07-09
- Results posted
- 2020-12-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01585194. Inclusion in this directory is not an endorsement.