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Cancer-Killing virus combined with immunotherapy shows promise in advanced tumors

NCT ID NCT03767348

Disease control Sponsor: Replimune, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests a genetically modified herpes virus (RP1) alone or with the immunotherapy drug nivolumab in people with advanced solid tumors, including melanoma, non-small cell lung cancer, and certain skin cancers. The study aims to see if the combination is safe and can shrink tumors. About 340 participants are enrolled across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RP1 (a genetically modified herpes simplex virus) and nivolumab (Opdivo, an immunotherapy drug)
What this could lead to
If successful, this combination could offer a new treatment option for several advanced solid tumors that are hard to treat.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply broadly. The virus-based therapy can cause side effects like flu-like symptoms and injection site reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma mismatch repair cancer syndrome 1 non-small cell lung carcinoma skin carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous melanoma Microsatellite instability-high (msi-H) Non-melanoma skin cancer (NMSC) Non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beatson West of Scotland Cancer Center

    Glasgow, Scotland, G12 0YN, United Kingdom

  • CHU Besancon - Hopital Jean Minjoz

    Besançon, 25000, France

  • CHU Dijon

    Dijon, 21079, France

  • CHU de Nice Hôpital l'Archet

    Nice, 06200, France

  • Carti Cancer Center

    Little Rock, Arkansas, 72205, United States

  • Centre Léon Bérard Lyon

    Lyon, 69373, France

  • Charité (Campus Benjamin Franklin)

    Berlin, 12203, Germany

  • Clinica Universitaria de Navarra

    Pamplona, 31008, Spain

  • Clínica Universidad de Navarra (Madrid)

    Madrid, 28027, Spain

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Eccles Outpatient Care Center- Oncology Clinical Trials

    Murray, Utah, 84107, United States

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hôpital Saint Louis APHP

    Paris, 75010, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Intermountain Cancer Center- Saint George Cancer Center

    St. George, Utah, 84790, United States

  • James Graham Brown Cancer Center- University of Louisville

    Louisville, Kentucky, 40202, United States

  • MUSC Health

    Charleston, South Carolina, 29425, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • New York University Clinical Cancer Center

    New York, New York, 10016, United States

  • Oxford University Hospitals NHS Trust

    Oxford, Oxfordshire, United Kingdom

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Royal Marsden Hospital

    London, United Kingdom

  • Seattle Cancer Care Alliance- University of Washington

    Seattle, Washington, 98109, United States

  • Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

    Marseille, 13005, France

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Sylvester Comprehensive Cancer Center- University of Miami

    Miami, Florida, 33136, United States

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH634JY, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UC San Diego

    La Jolla, California, 92093, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • Uniklinik Marburg

    Marburg, 35043, Germany

  • University Hospital Essen, Klinik für Dermatologie

    Essen, 45147, Germany

  • University of Birmingham Alabama

    Birmingham, Alabama, 35294, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of California- San Francisco

    San Francisco, California, 94115, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Iowa-Cancer Center Research

    Iowa City, Iowa, 52242, United States

  • University of Kiel (UKSH), Dep. of Dermatology

    Kiel, 24105, Germany

  • University of Leeds- Teaching Hospital

    Leeds, England, LS97TF, United Kingdom

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Wisconsin-Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • West Cancer Center

    Germantown, Tennessee, 38138, United States

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