Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Last updated: January 22, 2025
Sponsor: Replimune Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Melanoma

Skin Cancer

Treatment

nivolumab

RP1

Clinical Study ID

NCT03767348
RPL-001-16
  • Ages > 18
  • All Genders

Study Summary

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Eligibility Criteria

Inclusion

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 tumorsample 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-L1therapy.

  • Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that arenot considered treatable by surgery including basal cell carcinoma, cutaneoussquamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and othernon-melanoma skin cancers (per protocol). Patients must have received 8 weeks ofanti-PD1/PD-L1 as their last line of therapy and progressed while on treatment.

  • Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive diseasewhile 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, includingPD1/PD-L1 directed therapy administered either as monotherapy or in combination withplatinum-based chemotherapy or anti-CTLA-4. The most recent treatment given musthave included an anti-PD1/PD-L1 directed therapy with radiologic disease progressionon or after treatment.

Exclusion

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

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: nivolumab
Phase: 2
Study Start date:
September 20, 2017
Estimated Completion Date:
December 31, 2028

Study Description

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.

Connect with a study center

  • CHU Besancon - Hopital Jean Minjoz

    Besançon, 25000
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux, 33076
    France

    Site Not Available

  • CHU Dijon

    Dijon, 21079
    France

    Site Not Available

  • Centre Léon Bérard Lyon

    Lyon, 69373
    France

    Site Not Available

  • Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

    Marseille, 13005
    France

    Site Not Available

  • CHU de Nice Hôpital l'Archet

    Nice, 06200
    France

    Site Not Available

  • Hôpital Saint Louis APHP

    Paris, 75010
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

  • Charité (Campus Benjamin Franklin)

    Berlin, 12203
    Germany

    Site Not Available

  • University Hospital Essen, Klinik für Dermatologie

    Essen, 45147
    Germany

    Site Not Available

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

    Kiel, 24105
    Germany

    Site Not Available

  • Uniklinik Marburg

    Marburg, 35043
    Germany

    Site Not Available

  • Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Institut Catala D'Oncologia - Hospital Duran I

    Barcelona, 08908
    Spain

    Site Not Available

  • Clínica Universidad de Navarra (Madrid)

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • University of Leeds-

    Leeds, England LS97TF
    United Kingdom

    Site Not Available

  • University of Leeds- Teaching Hospital

    Leeds, England LS97TF
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Trust

    Oxford, Oxfordshire
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Center

    Glasgow, Scotland G12 0YN
    United Kingdom

    Site Not Available

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral CH634JY
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London,
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University of Birmingham Alabama

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Carti Cancer Center

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • UC San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Southern Californi

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of California, Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • University of California- San Francisco

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Yale School of Medicine- Smilow Cancer Center

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center- University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Iowa-Cancer Center Research

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • James Graham Brown Cancer Center- University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • New York University Clinical Cancer Center

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • MUSC Health

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • West Cancer Center

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Eccles Outpatient Care Center- Oncology Clinical Trials

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Intermountain Cancer Center- Saint George Cancer Center

    Saint George, Utah 84790
    United States

    Active - Recruiting

  • Seattle Cancer Care Alliance- University of Washington

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • University of Wisconsin-Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Medical College of Wisconsin- Cancer Center

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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