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Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

Primary Purpose

Cancer, Melanoma (Skin), Mismatch Repair Deficiency

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RP1
nivolumab
Sponsored by
Replimune Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Oncolytic virus, Oncolytic Immuno-gene therapy, Non-melanoma Skin Cancer, Cutaneous Melanoma, Anti-PD1 failed, Melanoma (skin)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Birmingham Alabama
  • Banner MD Anderson Cancer CenterRecruiting
  • Mayo ClinicRecruiting
  • Carti Cancer CenterRecruiting
  • UC San Diego
  • University of Southern CaliforniaRecruiting
  • UCLARecruiting
  • University of California, IrvineRecruiting
  • University of California- San FranciscoRecruiting
  • Sylvester Comprehensive Cancer Center- University of MiamiRecruiting
  • University of Iowa-Cancer Center ResearchRecruiting
  • James Graham Brown Cancer Center- University of LouisvilleRecruiting
  • Mayo ClinicRecruiting
  • Atlantic Health SystemRecruiting
  • New York University Clinical Cancer Center
  • Weill Cornell Medical CollegeRecruiting
  • University of Rochester Medical CenterRecruiting
  • Duke Cancer CenterRecruiting
  • University of Cincinnati Medical CenterRecruiting
  • Providence Portland Medical Center
  • MUSC HealthRecruiting
  • West Cancer CenterRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Eccles Outpatient Care Center- Oncology Clinical TrialsRecruiting
  • Intermountain Cancer Center- Saint George Cancer CenterRecruiting
  • Seattle Cancer Care Alliance- University of WashingtonRecruiting
  • University of Wisconsin-Carbone Cancer Center
  • CHU Besancon - Hopital Jean MinjozRecruiting
  • Institut BergoniéRecruiting
  • CHU DijonRecruiting
  • Centre Léon Bérard LyonRecruiting
  • Service de Dermatologie et Cancerologie Cutanee Hopital de la TimoneRecruiting
  • CHU de Nice Hôpital l'ArchetRecruiting
  • Hôpital Saint Louis APHPRecruiting
  • Institut Gustave RoussyRecruiting
  • Charité (Campus Benjamin Franklin)Recruiting
  • University Hospital Essen, Klinik für DermatologieRecruiting
  • University of Kiel (UKSH), Dep. of DermatologyRecruiting
  • Uniklinik MarburgRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Institut Catala D'Oncologia - Hospital Duran IRecruiting
  • Clínica Universidad de Navarra (Madrid)Recruiting
  • Hospital Universitario Virgen de la ArrixacaRecruiting
  • Clinica Universitaria de NavarraRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • University of Leeds- Teaching HospitalRecruiting
  • Oxford University Hospitals NHS TrustRecruiting
  • Beatson West of Scotland Cancer CenterRecruiting
  • The Clatterbridge Cancer Centre NHS Foundation TrustRecruiting
  • Royal Marsden HospitalRecruiting
  • Southampton General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors

Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors

Dose expansion of RP1 and nivolumab (IV) in superficial tumors

Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors

RP1 (IT) and nivolumab (IV) in melanoma

RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors

RP1 (IT) and nivolumab (IV) in NMSC

RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma

RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC

RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC

Arm Description

Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors

Dose escalation of RP1 alone in 3 cohorts with IT injections in deep/visceral tumors

Doses of RP1 (IT) in superficial tumors with nivolumab (IV)

Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy

Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy

Outcomes

Primary Outcome Measures

Percentage of adverse events (AEs)
Percentage of subjects with adverse events (AEs)
Percentage of serious adverse events (SAEs)
Percentage of subjects with serious adverse events (SAEs)
Percentage of dose limiting toxicities (DLTs)
Percentage of subjects with dose limiting toxicities (DLTs)
Percentage of overall response rate (ORR)
Percentage of overall response rate (ORR) for all participants
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation

Secondary Outcome Measures

Percentage of biologic activity
Percentage of subjects with biological activity determined by tumor biopsies and biomarker data
Percentage subjects with detectable RP1
Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP1
Percentage of complete response (CR)
Percentage of subjects with a complete response (CR)
Median duration of response
Median duration of response of subjects
Median progression-free survival
Median duration of progression-free survival of subjects
Median overall survival
Median overall survival rate of subjects

Full Information

First Posted
December 5, 2018
Last Updated
August 1, 2023
Sponsor
Replimune Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03767348
Brief Title
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
Acronym
IGNYTE
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Replimune Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Melanoma (Skin), Mismatch Repair Deficiency, Microsatellite Instability, Non-melanoma Skin Cancer, Cutaneous Melanoma, NSCLC
Keywords
Oncolytic virus, Oncolytic Immuno-gene therapy, Non-melanoma Skin Cancer, Cutaneous Melanoma, Anti-PD1 failed, Melanoma (skin)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors
Arm Type
Experimental
Arm Description
Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
Arm Title
Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors
Arm Type
Experimental
Arm Description
Dose escalation of RP1 alone in 3 cohorts with IT injections in deep/visceral tumors
Arm Title
Dose expansion of RP1 and nivolumab (IV) in superficial tumors
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial tumors with nivolumab (IV)
Arm Title
Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)
Arm Title
RP1 (IT) and nivolumab (IV) in melanoma
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma
Arm Title
RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors
Arm Title
RP1 (IT) and nivolumab (IV) in NMSC
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer
Arm Title
RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy
Arm Title
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy
Arm Title
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC
Arm Type
Experimental
Arm Description
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy
Intervention Type
Biological
Intervention Name(s)
RP1
Intervention Description
Genetically modified herpes simplex type 1 virus
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
anti-PD-1 monoclonal antibody
Primary Outcome Measure Information:
Title
Percentage of adverse events (AEs)
Description
Percentage of subjects with adverse events (AEs)
Time Frame
26 months
Title
Percentage of serious adverse events (SAEs)
Description
Percentage of subjects with serious adverse events (SAEs)
Time Frame
26 months
Title
Percentage of dose limiting toxicities (DLTs)
Description
Percentage of subjects with dose limiting toxicities (DLTs)
Time Frame
26 months
Title
Percentage of overall response rate (ORR)
Description
Percentage of overall response rate (ORR) for all participants
Time Frame
26 months
Title
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
Description
Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Percentage of biologic activity
Description
Percentage of subjects with biological activity determined by tumor biopsies and biomarker data
Time Frame
20 weeks
Title
Percentage subjects with detectable RP1
Description
Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP1
Time Frame
20 weeks
Title
Percentage of complete response (CR)
Description
Percentage of subjects with a complete response (CR)
Time Frame
26 months
Title
Median duration of response
Description
Median duration of response of subjects
Time Frame
26 months
Title
Median progression-free survival
Description
Median duration of progression-free survival of subjects
Time Frame
26 months
Title
Median overall survival
Description
Median overall survival rate of subjects
Time Frame
26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials at Replimune
Phone
1-781-222-9570
Email
Clinicaltrials@replimune.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie Hou, MD
Organizational Affiliation
Replimune Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Birmingham Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenesse Moffett
First Name & Middle Initial & Last Name & Degree
Jiaxin Niu, MD
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahesh Seetharam, MD
Facility Name
Carti Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Issam Makhoul, MD
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gino In, MD
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danell Johnson
First Name & Middle Initial & Last Name & Degree
Bartosz Chmielowski, MD
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Fruehauf, MD
Facility Name
University of California- San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Chow
First Name & Middle Initial & Last Name & Degree
Katy Tsai, MD
Facility Name
Sylvester Comprehensive Cancer Center- University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelamari Rodriguez, MD
Facility Name
University of Iowa-Cancer Center Research
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariel McKay
First Name & Middle Initial & Last Name & Degree
Mohammed Milhem, MBBS
Facility Name
James Graham Brown Cancer Center- University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Baum
First Name & Middle Initial & Last Name & Degree
Jason Chesney, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert McWilliams, MD
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Whitman, MD
Facility Name
New York University Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pavlick, DO
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delaney Dretto
First Name & Middle Initial & Last Name & Degree
Janice Cifelli
First Name & Middle Initial & Last Name & Degree
Rachael Turner, MD
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Beasley, MD
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MUSC Health
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kaczmar, MD
Facility Name
West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisa Harber
First Name & Middle Initial & Last Name & Degree
Ari Vanderwalde, MD
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Wong, MD
Facility Name
Eccles Outpatient Care Center- Oncology Clinical Trials
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tawnya Bowles
First Name & Middle Initial & Last Name & Degree
Tawnya Bowles, MD
Facility Name
Intermountain Cancer Center- Saint George Cancer Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angi Cox
First Name & Middle Initial & Last Name & Degree
Terence Rhodes, MD
Facility Name
Seattle Cancer Care Alliance- University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Kim
First Name & Middle Initial & Last Name & Degree
Evan Hall, MD
Facility Name
University of Wisconsin-Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
CHU Besancon - Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nardin Charlee, MD
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Italiano, MD
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Dalac-Rat, MD
Facility Name
Centre Léon Bérard Lyon
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona AMINI-ADLE, MD
First Name & Middle Initial & Last Name & Degree
Mona AMINI-ADLE, MD
Facility Name
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Gaudy, MD
Facility Name
CHU de Nice Hôpital l'Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri Montaudie, MD
Facility Name
Hôpital Saint Louis APHP
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céleste Lebbe, MD
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Michels, MD
Facility Name
Charité (Campus Benjamin Franklin)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Ochsenreither, MD
Facility Name
University Hospital Essen, Klinik für Dermatologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Schadendorf, MD
Facility Name
University of Kiel (UKSH), Dep. of Dermatology
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Kahler, MD
Facility Name
Uniklinik Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gschnell, MD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Couselo Munoz, MD
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Arance Fernández, MD
Facility Name
Institut Catala D'Oncologia - Hospital Duran I
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Liberal Martin, MD
Facility Name
Clínica Universidad de Navarra (Madrid)
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Fernández de Sanmamed
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Cerezuela, MD
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Gutiérrez Sanmamed, MD
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Gill, MD
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Jaime Berrocal, MD
Facility Name
University of Leeds- Teaching Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS97TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adel Samson, MD
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark R Middleton, MD,PhD,FRCP
Facility Name
Beatson West of Scotland Cancer Center
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Roxburgh, MD
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH634JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Sacco, MRCP, PhD
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Harrington, BSc FRCP PhD
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Karydis, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31399043
Citation
Thomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer. 2019 Aug 10;7(1):214. doi: 10.1186/s40425-019-0682-1.
Results Reference
derived

Learn more about this trial

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

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