A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma
- Sponsor
- Italian Network for Tumor Biotherapy
- Study ID
- NCT01654692
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Malignant Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab and Fotemustine — DRUGIpilimumab: 10 mg/kg q3 weeks for 4 doses, q12 weeks starting at Week 24 Fotemustine: 100 mg/m2 q1 week for 3 doses, q3 weeks starting at Week 9
Study Details
This study is designed to assess the safety and efficacy of a combination of ipilimumab and fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma.
Key Dates
- Start date
- Jun 30, 2010
- Status verified
- May 2015
- Primary completion
- May 31, 2012
- Completion
- Sep 30, 2014
Study Design
- Enrollment
- 86 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single arm of ipilimumab and fotemustineIpilimumab in combination with Fotemustine
Primary Outcome Measure
The immune response disease control rate (irDCR) using the immune-related (ir) tumor response criteria of the combination of ipilimumab and fotemustine in patients with unresectable locally advanced or metastatic melanoma. [ Time Frame: Weeks 24 ]