Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV Melanoma
- Sponsor
- Jewish General Hospital
- Study ID
- NCT01676649
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Untreated Stage III Melanoma or Stage IV Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — BIOLOGICAL3 mg/kg
- Carboplatin — DRUGAUC = 6
- Paclitaxel — DRUG175 mg/m2
Study Details
The safety of the combination of ipilimumab with carboplatin/paclitaxel treatment with two different dosing schedules will be investigated in patients with metastatic melanoma. This protocol will also investigate both the clinical benefit of this combination and the features of the host immune system that may predict response to ipilimumab with chemotherapy in patients with unresectable Stage III and Stage IV melanoma.
Key Dates
- Start date
- Nov 30, 2012
- Status verified
- Feb 2021
- Primary completion
- Feb 28, 2017
- Completion
- May 31, 2026
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: AArm A: Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 4, week 7, week 10, and week 13)
- Experimental: BCarboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 5, week 8, week 11, and week 14)
Primary Outcome Measure
Safety: Incidence of adverse events [ Time Frame: 24 months ]