Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Melanoma

IL-21/Ipilimumab Combination for Melanoma
A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma
Status Conditions Phase Study ID
Closed Melanoma Phase I NCT01489059
Summary

The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone.


Investigator
Shailender Bhatia, M.D.
Location    
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Unresectable Stage III or Stage IV melanoma
  • Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
  • Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Normal liver function tests
Exclusions (conditions that would prevent participation in this study)
  • Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
  • Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
  • Autoimmune disease
Last Updated
December 26, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.