Melanoma Clinical Trial

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

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.

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Full 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.

View Eligibility Criteria

Eligibility 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) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
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) for whom anti-PD1/PD-L1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
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: has confirmed progressive disease after no more than two prior systemic treatments including anti-PD1/PD-L1 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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT03767348

Recruitment Status:

Recruiting

Sponsor:

Replimune Inc.

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There are 50 Locations for this study

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University of Birmingham Alabama
Birmingham Alabama, 35294, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Jenesse Moffett
Contact
Jiaxin Niu, MD
Principal Investigator
Mayo Clinic
Phoenix Arizona, 85054, United States More Info
Aleksander Sekulic, MD
Principal Investigator
Carti Cancer Center
Little Rock Arkansas, 72205, United States More Info
Issam Makhoul, MD
Principal Investigator
UC San Diego
La Jolla California, 92093, United States More Info
Gregory Daniels, MD
Principal Investigator
University of Southern Californi
Los Angeles California, 90033, United States More Info
Gino In, MD
Contact
UCLA
Los Angeles California, 90095, United States More Info
Danell Johnson
Contact
Bartosz Chmielowski, MD
Principal Investigator
University of California, Irvine
Orange California, 92868, United States More Info
John Fruehauf, MD
Principal Investigator
University of California- San Francisco
San Francisco California, 94115, United States More Info
Melissa Chow
Contact
Katy Tsai, MD
Principal Investigator
Sylvester Comprehensive Cancer Center- University of Miami
Miami Florida, 33136, United States More Info
Estelamari Rodriguez, MD
Principal Investigator
University of Iowa-Cancer Center Research
Iowa City Iowa, 52242, United States More Info
Mariel McKay
Contact
Mohammed Milhem, MBBS
Principal Investigator
James Graham Brown Cancer Center- University of Louisville
Louisville Kentucky, 40202, United States More Info
Stacy Baum
Contact
Jason Chesney, MD
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Robert McWilliams, MD
Principal Investigator
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Eric Whitman, MD
Contact
New York University Clinical Cancer Center
New York New York, 10016, United States
Weill Cornell Medical College
New York New York, 10065, United States More Info
Anna Pavlick, DO
Principal Investigator
University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Delaney Dretto
Contact
Janice Cifelli
Contact
Rachael Turner, MD
Principal Investigator
Duke Cancer Center
Durham North Carolina, 27710, United States More Info
Georgia Beasley, MD
Contact
University of Cincinnati Medical Center
Cincinnati Ohio, 45267, United States More Info
Trisha Wise-Draper, MD
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States
MUSC Health
Charleston South Carolina, 29425, United States More Info
John Kaczmar, MD
Contact
West Cancer Center
Germantown Tennessee, 38138, United States More Info
Alisa Harber
Contact
Ari Vanderwalde, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Michael Wong, MD
Principal Investigator
Eccles Outpatient Care Center- Oncology Clinical Trials
Murray Utah, 84107, United States More Info
Tawnya Bowles
Contact
Tawnya Bowles, MD
Principal Investigator
Intermountain Cancer Center- Saint George Cancer Center
Saint George Utah, 84790, United States More Info
Angi Cox
Contact
Terence Rhodes, MD
Principal Investigator
Seattle Cancer Care Alliance- University of Washington
Seattle Washington, 98109, United States More Info
Katie Kim
Contact
Evan Hall, MD
Principal Investigator
University of Wisconsin-Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
Cancer Connect
Contact
Hamid Emamekhoo, MD
Principal Investigator
CHU Besancon - Hopital Jean Minjoz
Besançon , 25000, France More Info
Nardin Charlee, MD
Principal Investigator
Institut Bergonié
Bordeaux , 33076, France More Info
Antoine Italiano, MD
Principal Investigator
CHU Dijon
Dijon , 21079, France More Info
Sophie Dalac-Rat, MD
Principal Investigator
Centre Léon Bérard Lyon
Lyon , 69373, France More Info
Mona AMINI-ADLE, MD
Contact
Mona AMINI-ADLE, MD
Principal Investigator
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
Marseille , 13005, France More Info
Caroline Gaudy, MD
Principal Investigator
CHU de Nice Hôpital l'Archet
Nice , 06200, France More Info
Henri Montaudie, MD
Principal Investigator
Hôpital Saint Louis APHP
Paris , 75010, France More Info
Céleste Lebbe, MD
Principal Investigator
Institut Gustave Roussy
Villejuif , 94800, France More Info
Judith Michels, MD
Principal Investigator
Charité (Campus Benjamin Franklin)
Berlin , 12203, Germany More Info
Sebastian Ochsenreither, MD
Principal Investigator
University Hospital Essen, Klinik für Dermatologie
Essen , 45147, Germany More Info
Dirk Schadendorf, MD
Principal Investigator
University of Kiel (UKSH), Dep. of Dermatology
Kiel , 24105, Germany More Info
Katharina Kahler, MD
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain More Info
Eva Couselo Munoz, MD
Principal Investigator
Hospital Clinic Barcelona
Barcelona , 08036, Spain More Info
Ana Arance Fernández, MD
Principal Investigator
Institut Catala D'Oncologia - Hospital Duran I
Barcelona , 08908, Spain More Info
Juan Liberal Martin, MD
Principal Investigator
Clínica Universidad de Navarra (Madrid)
Madrid , 28027, Spain More Info
Miguel Fernández de Sanmamed
Principal Investigator
Hospital Universitario Virgen de la Arrixaca
Murcia , 30120, Spain More Info
Pablo Cerezuela, MD
Principal Investigator
Clinica Universitaria de Navarra
Pamplona , 31008, Spain More Info
Miguel Gutiérrez Sanmamed, MD
Principal Investigator
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain More Info
Mª Luisa (Maria Luisa) Mirón Limón, MD
Principal Investigator
Hospital General Universitario de Valencia
Valencia , 46014, Spain More Info
Alfonso Jaime Berrocal, MD
Principal Investigator
University of Leeds- Teaching Hospital
Leeds England, LS97T, United Kingdom More Info
Adel Samson, MD
Principal Investigator
Oxford University Hospitals NHS Trust
Oxford Oxfordshire, , United Kingdom More Info
Mark R Middleton, MD,PhD,FRCP
Principal Investigator
Beatson West of Scotland Cancer Center
Glasgow Scotland, G12 0, United Kingdom More Info
Patricia Roxburgh, MD
Principal Investigator
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington Wirral, CH634, United Kingdom More Info
Joseph Sacco, MRCP, PhD
Principal Investigator
Royal Marsden Hospital
London , , United Kingdom More Info
Kevin Harrington, BSc FRCP PhD
Principal Investigator
Southampton General Hospital
Southampton , SO16 , United Kingdom More Info
Ioannis Karydis, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

300

Study ID:

NCT03767348

Recruitment Status:

Recruiting

Sponsor:


Replimune Inc.

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