Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)
NCT ID: NCT03767348
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
340 participants
INTERVENTIONAL
2017-09-20
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors
anti-PD-1 monoclonal antibody
RP1
Genetically modified herpes simplex type 1 virus
Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors
Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
RP1
Genetically modified herpes simplex type 1 virus
Dose expansion of RP1 and nivolumab (IV) in superficial tumors
Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors
Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
RP1 (IT) and nivolumab (IV) in melanoma
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
RP1 (IT) and nivolumab (IV) in NMSC
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma
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
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC
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
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC
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
RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
Interventions
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RP1
Genetically modified herpes simplex type 1 virus
nivolumab
anti-PD-1 monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Replimune Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeannie Hou, MD
Role: STUDY_DIRECTOR
Replimune Inc.
Locations
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University of Birmingham Alabama
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Carti Cancer Center
Little Rock, Arkansas, United States
UC San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of California- San Francisco
San Francisco, California, United States
Sylvester Comprehensive Cancer Center- University of Miami
Miami, Florida, United States
University of Iowa-Cancer Center Research
Iowa City, Iowa, United States
James Graham Brown Cancer Center- University of Louisville
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
New York University Clinical Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
MUSC Health
Charleston, South Carolina, United States
West Cancer Center
Germantown, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Eccles Outpatient Care Center- Oncology Clinical Trials
Murray, Utah, United States
Intermountain Cancer Center- Saint George Cancer Center
St. George, Utah, United States
Seattle Cancer Care Alliance- University of Washington
Seattle, Washington, United States
University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, United States
CHU Besancon - Hopital Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
CHU Dijon
Dijon, , France
Centre Léon Bérard Lyon
Lyon, , France
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone
Marseille, , France
CHU de Nice Hôpital l'Archet
Nice, , France
Hôpital Saint Louis APHP
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Charité (Campus Benjamin Franklin)
Berlin, , Germany
University Hospital Essen, Klinik für Dermatologie
Essen, , Germany
University of Kiel (UKSH), Dep. of Dermatology
Kiel, , Germany
Uniklinik Marburg
Marburg, , Germany
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Clínica Universidad de Navarra (Madrid)
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
University of Leeds- Teaching Hospital
Leeds, England, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom
Beatson West of Scotland Cancer Center
Glasgow, Scotland, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Wong MK, Milhem MM, Sacco JJ, Michels J, In GK, Munoz Couselo E, Schadendorf D, Beasley GM, Niu J, Chmielowski B, Wise-Draper TM, Bowles TL, Tsai KK, Lebbe C, Gaudy-Marqueste C, Middleton MR, Skolariki A, Samson A, Chesney JA, VanderWalde AM, Zakharia Y, Harrington KJ, Appleton E, Bommareddy PK, Zhu J, Viana M, Hou JW, Coffin RS, Robert C. RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE). J Clin Oncol. 2025 Nov 20;43(33):3589-3599. doi: 10.1200/JCO-25-01346. Epub 2025 Jul 8.
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.
Other Identifiers
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2016-004548-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511728-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
RPL-001-16
Identifier Type: -
Identifier Source: org_study_id