Clinical Trials

Clinical Trial Detail

Return to search results.

Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

Complete title: A Phase 1 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

Research Study Number       20111942
    
Principal Investigator       Shailender Bhatia, MD
    
Phase       I

Look up trial at NIH

Research Study Description

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

Eligibility Criteria (must meet the following to participate in this study)

- Ages Eligible for Study: 18 Years and older

- Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

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

Other exclusion criteria may apply.



Research Study Number       20111942
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
    

Keywords
Eye Cancer; Melanoma; Skin Cancer; Solid Tumors

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.

Subscribe to an RSS feed of all trials

Fred Hutchinson Cancer Research Center is a world leader in research to prevent, detect and treat cancer and other life-threatening diseases.