IGNYTE-3 – A Phase 3 Study Evaluating RP1 (VO) and Nivolumab vs Physician’s Choice in Advanced Melanoma That Progressed on Anti-PD1 & Anti-CTLA-4 Drugs
For more information about the IGNYTE study, please see Clinical Trials.gov:
ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06264180
Identifier: NCT06264180
This is a randomized, controlled, multicenter, open-label Phase 3 clinical trial to study the
investigational oncolytic immunotherapy RP1 given in combination with nivolumab versus
Physician’s Choice treatment for patients with advanced melanoma.
Who is this study for?
The study is currently in Phase 3 and is for patients with a diagnosis of unresectable or metastatic Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti-PD1 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.
Key eligibility criteria
You may be eligible for this study if you meet the following conditions (note, full eligibility and exclusion criteria is available at clinicaltrials.gov):
- Are capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form.
- Are at least 12 years of age or older.
- Have at least 1 measurable and injectable tumor of ≥1 cm in longest diameter (or shortest diameter for lymph nodes).
- Have not received prior treatment with an oncolytic virus therapy or other therapy by intratumoral administration.
- Have not received more than two lines of prior treatment for advanced melanoma
- Have no acute or chronic active hepatitis B and C virus infection, no known history of hepatitis B, and no HIV infection.
- Have no systemic infection requiring intravenous (IV) antibiotics nor other serious infections within 14 days prior to dosing.
What to expect during the study
The study has three different phases. They are:
- Screening: Up to 28 days
- Treatment Period: Up to approximately 2 years
- Follow-up Period: Up to 3 years after treatment is completed
After the screening phase is completed, patients meeting all the inclusion criteria will be randomized into 1 of 2 treatment groups: RP1 + nivolumab or Physician’s Choice of treatment, which is an approved standard treatment for advanced melanoma.
Dosing of RP1 will start on Day 1 and will be administered directly into the tumor every 2 weeks for up to 8 cycles (approximately 4 months). After the first dose of RP1, dosing will be given with concurrent nivolumab infusion every 2 weeks followed by dosing every 4 weeks for up to an additional 20 months. Antitumor activity will be based on radiological and/or clinical evaluation and all patients will be assessed at Screening and once every 12 weeks.
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