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Treatment using RP1 alone and with nivolumab for advanced skin cancer

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

Phase 2 Interventional Replimune Inc. · NCT03767348

This study is testing a new treatment using a modified virus alone and with an immune booster to see if it helps adults with advanced skin cancer feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorReplimune Inc. Industry-sponsored
Drugs / interventionschemotherapy, nivolumab
Locations53 sites (Birmingham, Alabama and 52 other locations)
Trial IDNCT03767348 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of RP1, a genetically modified herpes simplex virus, both alone and in combination with nivolumab, an immune checkpoint inhibitor, in adults with advanced or refractory solid tumors, particularly melanoma and non-melanoma skin cancers. The study is structured in phases, starting with dose escalation to determine the maximum tolerated dose, followed by an expansion phase to assess the combination therapy's efficacy. Participants will be monitored for tumor response and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced melanoma or non-melanoma skin cancers who have progressed on prior anti-PD1/PD-L1 therapy.

Not a fit: Patients with tumors that are not advanced or those who have not previously received anti-PD1/PD-L1 therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced skin cancers that have not responded to previous therapies.

How similar studies have performed: Previous studies using oncolytic viruses and immune checkpoint inhibitors have shown promising results, indicating potential for success in this novel combination approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

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

Where this trial is running

Birmingham, Alabama and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CancerMelanomaMismatch Repair DeficiencyMicrosatellite InstabilityNon-melanoma Skin CancerCutaneous MelanomaNSCLCOncolytic virus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.