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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004548-12 | EudraCT Number | ||
| 2024-511728-15-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The Phase 2 study is a multicenter, open-label study of RP1 to further investigate safety and to estimate the efficacy of RP1 at the RP2D in combination with nivolumab in patients with Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors | Experimental | anti-PD-1 monoclonal antibody |
|
| Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors | Experimental | Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors |
|
| Dose expansion of RP1 and nivolumab (IV) in superficial tumors | Experimental | Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors |
|
| Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors | Experimental | Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV) |
|
| RP1 (IT) and nivolumab (IV) in melanoma | Experimental | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP1 | Biological | Genetically modified herpes simplex type 1 virus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse events (AEs) | Percentage of subjects with adverse events (AEs) | 26 months |
| Percentage of serious adverse events (SAEs) | Percentage of subjects with serious adverse events (SAEs) | 26 months |
| Percentage of dose limiting toxicities (DLTs) | Percentage of subjects with dose limiting toxicities (DLTs) | 26 months |
| Percentage of overall response rate (ORR) | Percentage of overall response rate (ORR) for all participants | 26 months |
| 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 | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of biologic activity | Percentage of subjects with biological activity determined by tumor biopsies and biomarker data | 20 weeks |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannie Hou, MD | Replimune, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Birmingham Alabama | Birmingham | Alabama | 35294 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40627813 | Derived | 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. | |
| 31399043 |
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| RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors | Experimental | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors |
|
| RP1 (IT) and nivolumab (IV) in NMSC | Experimental | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer |
|
| RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma | Experimental | 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(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC | Experimental | 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(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC | Experimental | 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 |
|
| nivolumab | Biological | anti-PD-1 monoclonal antibody |
|
|
| 20 weeks |
| Percentage of complete response (CR) | Percentage of subjects with a complete response (CR) | 26 months |
| Median duration of response | Median duration of response of subjects | 26 months |
| Median progression-free survival | Median duration of progression-free survival of subjects | 26 months |
| Median overall survival | Median overall survival rate of subjects | 26 months |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
| Carti Cancer Center | Little Rock | Arkansas | 72205 | United States |
| UC San Diego | La Jolla | California | 92093 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| UCLA | Los Angeles | California | 90095 | United States |
| University of California, Irvine | Orange | California | 92868 | United States |
| University of California- San Francisco | San Francisco | California | 94115 | United States |
| Sylvester Comprehensive Cancer Center- University of Miami | Miami | Florida | 33136 | United States |
| University of Iowa-Cancer Center Research | Iowa City | Iowa | 52242 | United States |
| James Graham Brown Cancer Center- University of Louisville | Louisville | Kentucky | 40202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| New York University Clinical Cancer Center | New York | New York | 10016 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| MUSC Health | Charleston | South Carolina | 29425 | United States |
| West Cancer Center | Germantown | Tennessee | 38138 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Eccles Outpatient Care Center- Oncology Clinical Trials | Murray | Utah | 84107 | United States |
| Intermountain Cancer Center- Saint George Cancer Center | St. George | Utah | 84790 | United States |
| Seattle Cancer Care Alliance- University of Washington | Seattle | Washington | 98109 | United States |
| University of Wisconsin-Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| CHU Besancon - Hopital Jean Minjoz | Besançon | 25000 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| CHU Dijon | Dijon | 21079 | France |
| Centre Léon Bérard Lyon | Lyon | 69373 | France |
| Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone | Marseille | 13005 | France |
| CHU de Nice Hôpital l'Archet | Nice | 06200 | France |
| Hôpital Saint Louis APHP | Paris | 75010 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| Charité (Campus Benjamin Franklin) | Berlin | 12203 | Germany |
| University Hospital Essen, Klinik für Dermatologie | Essen | 45147 | Germany |
| University of Kiel (UKSH), Dep. of Dermatology | Kiel | 24105 | Germany |
| Uniklinik Marburg | Marburg | 35043 | Germany |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Clínica Universidad de Navarra (Madrid) | Madrid | 28027 | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Clinica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| University of Leeds- Teaching Hospital | Leeds | England | LS97TF | United Kingdom |
| Oxford University Hospitals NHS Trust | Oxford | Oxfordshire | United Kingdom |
| Beatson West of Scotland Cancer Center | Glasgow | Scotland | G12 0YN | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Bebington | Wirral | CH634JY | United Kingdom |
| Royal Marsden Hospital | London | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| C536928 | Turcot syndrome |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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