Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Feb 13, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Replimune, Inc.
- Interventions being studied
- Biological: RP1; Biological: nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * At least one measurable and injectable lesion * Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy * Have a predicted life expectancy of ≥ 3 months * Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria * Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) who has progressed on prior anti-PD1/PD-L1 therapy. * Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol). Patients must have received 8 weeks of anti-PD1/PD-L1 as their last line of therapy and progressed while on treatment. * Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status * Subjects with anti-PD1 failed NSCLC: must have failed prior treatment, including PD1/PD-L1 directed therapy administered either as monotherapy or in combination with platinum-based chemotherapy or anti-CTLA-4. The most recent treatment given must have included an anti-PD1/PD-L1 directed therapy with radiologic disease progression on or after treatment. Key Exclusion Criteria: * Prior treatment with an oncolytic therapy * History of viral infections according to the protocol * Prior complications with herpes infections * Chronic use of anti-virals * Uncontrolled/untreated brain metastasis * History of interstitial lung disease * History of non-infectious pneumonitis * History of clinically significant cardiovascular disease
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Birmingham AlabamaBirmingham, Alabama
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Mayo ClinicPhoenix, Arizona
- Carti Cancer CenterLittle Rock, Arkansas
- UC San DiegoLa Jolla, California
- University of Southern CaliforniaLos Angeles, California
- UCLALos Angeles, California
- University of California, IrvineOrange, California
- University of California- San FranciscoSan Francisco, California
- Sylvester Comprehensive Cancer Center- University of MiamiMiami, Florida
- University of Iowa-Cancer Center ResearchIowa City, Iowa
- James Graham Brown Cancer Center- University of LouisvilleLouisville, Kentucky
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2026. Always confirm current availability with the study team.