VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)
12 Years and older, Male and Female
RP1-104 (primary)
NCI-2024-04401
Summary
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study
comparing VO in combination with nivolumab versus Physician's Choice treatment for
patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on
an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination
regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4
therapy.
Eligibility
- Male or female who is 12 years of age or older at the time of signed informed consent.
- Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma.
- Confirmed disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence.
- Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks
- Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody are eligible
- Has documented BRAF V600 mutation status. Patients with BRAF mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition or prior toxicity.
- Has at least 1 measurable and injectable tumor of =1 cm in longest diameter (or shortest diameter for lymph nodes).
- Has adequate hematologic function.
- Has adequate hepatic function.
- Has adequate renal function.
- Prothrombin time (PT) =1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =1.5 × ULN
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 for patients 18 years and older or a Lansky performance score (PSc) =80 for patients 12 to 17 years of age.
- Life expectancy of at least 3 months.
- Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirements during the treatment period and for at least 6 months after the last dose of study treatment.
- Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) test within 72 hours before the first dose of study treatment. Key
Treatment Sites in Georgia
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