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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase:
Randomized


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab

Outcome Description:

Based on the dose-limiting toxicity (DLT) rate

Outcome Time Frame:

Within the first 63 days

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA220-007

NCT ID:

NCT01489059

Start Date:

December 2011

Completion Date:

November 2014

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Seattle Cancer Care Alliance Seattle, Washington  98109
Oncology Research Associates, Pllc D/B/A Scottsdale, Arizona  85258
Portland Providence Medical Center Portland, Oregon  97213
H. Lee Moffitt Cancer Center & Research Inst, Inc Tampa, Florida  33612
University Of Louisville Medical Center, Inc., Dba Louisville, Kentucky  40202
Md Anderson Can Cnt Houston, Texas  77030-4009