Completed
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
What is being tested
BMS-982470 (recombinant interleukin-21)
+ Ipilimumab
Biological
Who is being recruted
Melanoma+9
+ Neoplasms
+ Neoplasms by Histologic Type
Over 18 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: December 2011
Summary
Principal SponsorBristol-Myers Squibb
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2011
Actual date on which the first participant was enrolled.Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
Official TitleA 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
Principal SponsorBristol-Myers Squibb
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors
Criteria
3 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDose Escalation
Group II
ExperimentalDose Escalation
Group III
ExperimentalCohort Expansion
Group IV
ExperimentalCohort Expansion
Group 5
Active ComparatorCohort Expansion
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Suspended
Oncology Research Associates, Pllc D/B/A
Scottsdale, United StatesOpen Oncology Research Associates, Pllc D/B/A in Google MapsSuspended
Ucla Hematology/Oncology.
Los Angeles, United StatesSuspended
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, United StatesSuspended
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, United StatesCompleted9 Study Centers