Clinical Evaluation of Yervoy in Combination With Adoptive T Cell Transfer for Metastatic Melanoma Patients
- Sponsor
- Sheba Medical Center
- Study ID
- NCT01988077
- Phase
- PHASE2
- Status
- Terminated
Conditions
- A Combination of Adoptive T Cell Therapy and Ipilimumab Could Increase the Proportion of CR Patients, and Durability of Response
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adoptive cell transfer — BIOLOGICALAdoptive cell transfer
- Ipilimumab 5 MG/ML Injection [Yervoy] — DRUG2 treatments of Ipilimumab before transfer of TIL and 2 treatments of Ipilimumab after TIL
Study Details
A rationally designed combination of adoptive T cell therapy and ipilimumab could strongly increase the proportion of CR patients, as well as the durability of response, as compared to ipilimumab or TIL alone. The investigators hypothesize that the combination of those two important modalities could result in a durable (≥ 1 year) complete response rate of 30% in stage IV melanoma patients.
Key Dates
- Start date
- Oct 31, 2013
- Status verified
- Apr 2019
- Primary completion
- May 20, 2016
- Completion
- Oct 25, 2018
Study Design
- Enrollment
- 2 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Adoptive cell transfer combined with IpilimumabAdoptive cell transfer combined with Ipilimumab
Primary Outcome Measure
Determine the response rate of the combination of ipilimumab with young TIL protocol and the CR rate of this combination according to modified RECIST 1.1. [ Time Frame: October 2017 ]