Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Yana Najjar
Study ID
NCT04493203
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Melanoma
  • Unresectable Melanoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
  • Axitinib — DRUG
    Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)

Study Details

This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.

Key Dates

Start date
Dec 18, 2020
Status verified
Jun 2025
Primary completion
Apr 15, 2024
Completion
Apr 12, 2025

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab plus Axitinib
    Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 12 weeks from baseline (after treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

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By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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