Axitinib + Ipilimumab in Advanced Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04996823
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.
  • Axitinib — DRUG
    Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)

Study Details

The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.

Key Dates

Start date
Aug 4, 2021
Status verified
Dec 2025
Primary completion
Aug 20, 2026
Completion
Mar 29, 2027

Study Design

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

Arms

  • Experimental: Ipilimumab + Axtinib
    Participants will receive treatment with ipilimumab 3 mg/kg IV q3 weeks x 4 doses and axitinib at 5 mg by mouth twice daily. Each cycle is 3 weeks/21 days

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Zeynep Eroglu, MD (PRINCIPAL_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Nikhil Khushalani, MD (SUB_INVESTIGATOR)
Joseph Markowitz, MD, PhD (SUB_INVESTIGATOR)

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