IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04562129
Phase
PHASE2
Status
Recruiting
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Conditions

  • Inoperable Disease
  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interleukin-2 — DRUG
    High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)
  • Ipilimumab — DRUG
    Low dose Ipilimumab given at time of HD IL2 administration on day 1 of the first 2 cycles of each course.
  • Nivolumab — DRUG
    Nivolumab will be given at a dose of 480 mg IV week 7 of each course.

Study Details

The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.

Key Dates

Start date
Sep 24, 2020
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Nov 30, 2029

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    HD IL2 (600,000 units/kg/dose IV) will be given during week 1 of the 2 initial cycles or each course. Ipilimumab will be given concurrently at the low dose of 1 mg/kg during week one of the 2 initial cycles of each course for up to 2 doses, total. Nivolumab will be given on during week one of the 3rd cycle of each course. No systemic treatment will be administered during the 4th cycle. Patients without evidence of disease progression (RECIST v.1.1) or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses, total.

Primary Outcome Measure

Response Rate [ Time Frame: Up to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Leticia Tetteh
[email protected]
813-745-4617
Ahmad Tarhini, MD, PhD (PRINCIPAL_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Zeynep Eroglu, MD (SUB_INVESTIGATOR)
Nikhil Khushalani, MD (SUB_INVESTIGATOR)
Joseph Markowitz, MD, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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