Thinking of joining a study?

Register your interest

Become a volunteer?

NCT03767348 | RECRUITING | Cancer

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
Sponsor:

Replimune Inc.

Brief 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.

Condition or disease

Cancer

Melanoma (Skin)

Mismatch Repair Deficiency

Microsatellite Instability

Non-melanoma Skin Cancer

Cutaneous Melanoma

NSCLC

Intervention/treatment

RP1

nivolumab

Phase

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 340 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2017-09-20
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

Location Details

NCT03767348

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

United States, Albama

University of Birmingham Alabama

Birmingham, Albama, United States, 35294

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

RECRUITING

United States, Arizona

Mayo Clinic

Phoenix, Arizona, United States, 85054

RECRUITING

United States, Arkansa

Cancer Center books

Little Rock, Arkansa, United States, 72205

ACTIVE NOT RECRUITING

United States, California

UC San Diego

THE JOLLA, California, United States, 92093

RECRUITING

United States, California

University of Southern California

Los Angeles, California, United States, 90033

RECRUITING

United States, California

UCLA

Los Angeles, California, United States, 90095

RECRUITING

United States, California

University of California, Irvine

Orange, California, United States, 92868

RECRUITING

United States, California

University of California- San Francisco

San Francisco, California, United States, 94115

ACTIVE NOT RECRUITING

United States, Florida

Sylvester Comprehensive Cancer Center- University of Miami

Miami, Florida, United States, 33136

RECRUITING

United States, Iowa

University of Iowa-Cancer Center Research

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Kentucky

James Graham Brown Cancer Center- University of Louisville

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New Jersey

Atlantic Health System

Morristown, New Jersey, United States, 07960

ACTIVE NOT RECRUITING

United States, New York

New York University Clinical Cancer Center

New York, New York, United States, 10016

RECRUITING

United States, New York

Weill Cornell Medical College

New York, New York, United States, 10065

RECRUITING

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642

RECRUITING

United States, North Carolina

Duke Cancer Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45267

ACTIVE NOT RECRUITING

United States, Oregon

Providence Portland Medical Center

Portland, Oregon, United States, 97213

RECRUITING

United States, South Carolina

MUSC Health

Charleston, South Carolina, United States, 29425

RECRUITING

United States, Tennessee

West Cancer Center

Germantown, Tennessee, United States, 38138

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

Eccles Outpatient Care Center- Oncology Clinical Trials

Murray, Utah, United States, 84107

RECRUITING

United States, Utah

Intermountain Cancer Center- Saint George Cancer Center

Saint George, Utah, United States, 84790

RECRUITING

United States, Washington

Seattle Cancer Care Alliance- University of Washington

Seattle, Washington, United States, 98109

ACTIVE NOT RECRUITING

United States, Wisconsin

University of Wisconsin-Carbone Cancer Center

Madison, Wisconsin, United States, 53792

ACTIVE NOT RECRUITING

France,

CHU BESANCON - HOPITAL Jean Minjoz

Besançon, France, 25000

ACTIVE NOT RECRUITING

France,

Institute of Bergonié

Bordeaux, France, 33076

ACTIVE NOT RECRUITING

France,

Chu Dijon

Dijon, France, 21079

ACTIVE NOT RECRUITING

France,

Center Léon Bérard Lyon

Lyon, France, 69373

ACTIVE NOT RECRUITING

France,

DERMATOLOGY AND CANCEROLOGY SEAR

Marseille, France, 13005

ACTIVE NOT RECRUITING

France,

CHU of Nice Hospital L'Archet

Nice, France, 06200

ACTIVE NOT RECRUITING

France,

Saint Louis APHP Hospital

Paris, France, 75010

ACTIVE NOT RECRUITING

France,

Gustave Roussy Institute

Villejuif, France, 94800

ACTIVE NOT RECRUITING

Germany,

Charity (Campus Benjamin Franklin)

Berlin, Germany, 12203

ACTIVE NOT RECRUITING

Germany,

University Hospital Essen, Clinic for Dermatology

Essen, Germany, 45147

ACTIVE NOT RECRUITING

Germany,

University of Kiel (UKSH), Dep. of Dermatology

As, Germany, 24105

ACTIVE NOT RECRUITING

Germany,

University Hospital Marburg

Marburg, Germany, 35043

ACTIVE NOT RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

ACTIVE NOT RECRUITING

Spain,

Hospital Clinic Barcelona

Barcelona, Spain, 08036

ACTIVE NOT RECRUITING

Spain,

Institute Catalan Of Oncology - Duran Hospital I

Barcelona, Spain, 08908

ACTIVE NOT RECRUITING

Spain,

Clinic University of Navarra (Madrid)

Madrid, Spain, 28027

ACTIVE NOT RECRUITING

Spain,

Virgen de la Arrixaca University Hospital

Murcia, Spain, 30120

ACTIVE NOT RECRUITING

Spain,

University Clinic of Navarra

Pamplona, Spain, 31008

ACTIVE NOT RECRUITING

Spain,

Virgen del Rocio University Hospital

Sevilla, Spain, 41013

ACTIVE NOT RECRUITING

Spain,

General University Hospital of Valencia

Valencia, Spain, 46014

ACTIVE NOT RECRUITING

United Kingdom, England

University of Leeds- Teaching Hospital

Leeds, England, United Kingdom, LS97TF

ACTIVE NOT RECRUITING

United Kingdom, Oxfordshire

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, United Kingdom,

ACTIVE NOT RECRUITING

United Kingdom, Scotland

Beatson West of Scotland Cancer Center

Glasgow, Scotland, United Kingdom, G12 0yn

ACTIVE NOT RECRUITING

United Kingdom, Wirral

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, United Kingdom, Sitting 4G

ACTIVE NOT RECRUITING

United Kingdom,

Royal Marsden Hospital

London, United Kingdom,

ACTIVE NOT RECRUITING

United Kingdom,

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD