Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full description
Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
42 participants in 5 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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