PVSRIPO in Combination With Nivolumab in Melanoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Darell Bigner
Study ID
NCT04125719
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • PVSRIPO — BIOLOGICAL
    Intralesional injection of PVSRIPO
  • Nivolumab — DRUG
    Nivolumab infusion

Study Details

In this study, patients with metastatic melanoma who have at least one injectable lesion that has been refractory to PD-1 therapy (n=30 patients) will be enrolled. Cohort 1 will include 15 patients who progressed within 3 months (primary resistance) of starting PD-1 therapy and cohort 2 will be patients who progressed after at least 3 months of PD-1 therapy. Patients will receive up to 7 injections of PVSRIPO intra-lesionally in combination with Nivolumab. Nivolumab will be administered according to the FDA-approved dosing schedule of 480 mg intravenously every 4 weeks, beginning \~10 days after the first PVSRIPO infusion and will continue for 4 cycles. Nivolumab may be continued up to 2 years per standard of care after the completion of the PVSRIPO injections.

Key Dates

Start date
Jun 1, 2020
Status verified
Feb 2020
Primary completion
Oct 1, 2024
Completion
Oct 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Primay PD-1 resistance
    Cohort 1 will include 15 patients who progressed within 3 months (primary resistance) of starting PD-1 therapy
  • Experimental: Secondary PD-1 resistance
    Cohort 2 will include 15 patients who progressed after at least 3 months of PD-1 therapy

Primary Outcome Measure

Assess the percent of adverse events related to the combination of PVSRIPO + nivolumab in the treatment of patients with recurrent melanoma. [ Time Frame: 36 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Duke University Medical Center· Durham, NC

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