[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Replimune, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,74,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100536388","phase-3-vo-and-nivolumab-vs-physicians-choice-in-advanced-melanoma-that-progressed-on-anti-pd-1--anti-ctla-4-drugs-ignyte-3-100536388",false,"NCT06264180","VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]","Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]","Key Inclusion Criteria:\n\nI 1. Male or female who is 12 years of age or older at the time of signed informed consent.\n\nI 2. Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV\u002FM1a through M1d cutaneous melanoma, as per AJCC staging system, 8th edition).\n\nI 3. Confirmed disease progression (PD) on an anti-PD-1 antibody treatment and an anti-CTLA-4 antibody treatment, administered as either a combination regimen (eg, nivolumab + ipilimumab) or in sequence.\n\n1. Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks (note: treatment with prior pembrolizumab therapy when administered every 6 weeks must have continued for a minimum of 12 weeks \\[ie, 2 treatment cycles\\]). Any number of doses of prior anti-CTLA-4 therapy may have been administered in combination with an anti-PD-1. The anti-PD-1-containing therapy must be the immediate prior line of treatment before randomization (for patients with BRAF mutation, see I 4).\n2. Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody (eg, due to documented clinically significant comorbidities or history of immune-related adverse events) are eligible for the study if they have confirmed PD on an anti-PD-1 antibody (including unresectable disease relapse during adjuvant therapy or \\\u003C 6 months from completion of adjuvant therapy).\n3. Disease progression must have been confirmed and documented using clinical or radiological assessment by 2 assessments at least 4 weeks apart while being treated with an anti-PD-1 antibody and an anti-CTLA-4 antibody. Radiological confirmation of PD can occur during the Screening period for this study. Treatment with prior anti-PD-1 therapy must have continued from the time of initial tumor progression until confirmation of PD (ie, such that no doses of anti-PD-1 therapy were missed).\n\nNote: If radiographic progression at the initial scan where PD was documented is accompanied by clear clinical progression, defined as a decline in performance status directly attributed to disease or increased disease-related symptoms, anti-PD-1 therapy does not need to continue. For patients with documented PD while on adjuvant therapy with an anti-PD-1 therapy, a confirmatory biopsy can be used in place of a confirmatory scan.\n\nI 4. Has documented BRAF V600 mutation status or must consent to BRAF V600 mutation testing per local institutional standards during the Screening period. Patients with BRAF mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to randomization, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition or prior toxicity.\n\nNote: Prior exposure to BRAF-directed therapy (with or without a MEK inhibitor) includes treatment in the adjuvant setting. One line of BRAF-directed therapy (with or without a MEK inhibitor) can be the most recent systemic treatment administered before randomization.\n\nI 5. Has least 1 measurable tumor of ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes) and injectable lesion(s) of at least 1 cm in longest diameter.\n\nI 6. Has adequate hematologic function, including:\n\n1. White blood cell (WBC) count ≥ 2.0 × 109\u002FL\n2. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n3. Platelet count ≥ 75 × 109\u002FL\n4. Hemoglobin ≥ 8 g\u002FdL (without packed red blood cell \\[RBC\\] transfusion within 2 weeks of dosing)\n\nI 7. Has adequate hepatic function, including:\n\n1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN; \\\u003C 2.0 × ULN for patients with known Gilbert syndrome or liver metastases)\n2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × ULN (or ≤ 5.0 × ULN, if liver metastases are present)\n3. Alkaline phosphatase (ALP) ≤ 2.5 × ULN (or ≤ 5.0 × ULN, if liver or bone metastases are present) I 8. Has adequate renal function, defined as serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 3 0 mL\u002Fminute\u002F1.73 m2 (measured using Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula).\n\nI 9. Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \\[INR\\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Note: Patients who are on chronic anticoagulant therapy may be randomized if the target INR is ≤ 2.5. For patients requiring deep injection of VO, the INR must be \\\u003C1.5 at the time of injection.\n\nI 10. ECOG performance status (PS) 0 to 1 for patients 18 and older or a Lansky PS ≥ 80 for patients 12 to 17 years of age.\n\nI 11. Life expectancy of at least 3 months. I 12. Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception requirements during the treatment period and for at least 6 months after the last dose of any study treatment.\n\nI 13. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU\u002FL or equivalent units or β hCG within 7 days before the first dose of study treatment.\n\nI 14. Capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form (ICF)\n\nKey Exclusion Criteria:\n\nE 1. Primary mucosal or uveal melanoma. E 2. More than 2 lines of systemic therapy for advanced melanoma. Note: One additional line of anti-PD-1 therapy in the adjuvant or neoadjuvant setting is allowed if the patient was free of treatment and of PD for at least 6 months and subsequently had confirmed PD on an anti-PD-1 and an anti-CTLA-4 antibody therapy administered in the advanced setting.\n\nE 3. Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known acute or chronic hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected).\n\nNote: Patients who have been effectively treated are eligible for randomization. Patients must be negative for HBsAg and HCV RNA.\n\nE 4. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.\n\nE 5. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).\n\nNote: Patients with sporadic cold sores may be randomized if no active cold sores are present at the time of first dose of study treatment.\n\nE 6. Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to the first dose.\n\nE 7. Evidence of spinal cord compression or at high risk of spinal cord compression.\n\nE 8. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis at time of screening. Patients with known central nervous system metastases are eligible if they have received standard-of-care therapy for central nervous system disease (such as stereotactic radiosurgery or radical surgical resection followed by radiotherapy) and have evidence of disease stability on 2 subsequent scans performed at least at a 4-week interval.\n\nE 9. Serum lactate dehydrogenase (LDH) \\> 2 × ULN. E 10. Major surgery ≤ 2 weeks prior to starting study treatment. Note: Patients must have recovered adequately from all acute complications of all previous procedures prior to randomization.\n\nE 11. Prior malignancy active within the previous 3 years, except for locally curable cancers that have apparently been cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ (without invasive component) of the prostate, cervix, or breast.\n\nE 12. History of significant cardiac disease including myocarditis or congestive heart failure (defined as New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, cerebral vascular accident, or myocardial infarction within 6 months from first dose of VO.\n\nE 13. History of life-threatening toxicity related to prior immune therapy except those that are unlikely to recur with standard countermeasures (eg, hormone replacement after adrenal crisis).\n\nE 14. History or evidence of psychiatric, substance abuse (including IV substance abuse), or any other clinically significant disorder, condition, or disease (with the exception of those described above) that, in the opinion of the Investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.\n\nE 15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n\nE 16. Active, known, or suspected autoimmune disease requiring systemic treatment.\n\nE 17. History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.\n\nE 18. Prior oncolytic virus therapy or other therapy given by intratumoral administration.\n\nE 19. Requires chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).\n\nE 20. Has received a live vaccine within 28 days prior to the first dose of study treatment.\n\nE 21. Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.\n\nE 22. Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment.\n\nE 23. Has received prior radiotherapy within 2 weeks of start of study treatment or has not recovered from radiotherapy.\n\nE 24. Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy 14 days before randomization.\n\nNote: Patients who require a brief course (≤ 7 days) or corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic corticosteroids are permitted, only if the dose does not exceed 10 mg\u002Fday prednisone equivalent.\n\nE 25. History of allergy or sensitivity to study drug components (VO, nivolumab, pembrolizumab, or relatlimab) or to cisplatin or carboplatin or paclitaxel (dependent on cohort) or prior monoclonal antibody treatment.\n\nE 26. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to treatment.\n\nE 27. Is a person who is deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.","ALL","12 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.",[26],"Advanced Melanoma","RECRUITING","2026-05-14",{"date":30,"type":31},"2026-05-15","ACTUAL",{"date":33,"type":31},"2024-07-11",{"date":35,"type":20},"2034-08-31",{"name":37,"class":38},"Replimune, Inc.","INDUSTRY",81,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100560765","phase-2-a-randomized-phase-23-study-to-investigate-the-efficacy-and-safety-of-rp2-in-combination-with-nivolumab-in-immune-checkpoint-inhibitor-nave-adult-patients-with-metastatic-uveal-melanoma-100560765","NCT06581406","A Randomized, Phase 2\u002F3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma","A Randomized, Phase 2\u002F3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma","Key Inclusion Criteria:\n\n* Patients who are 18 years of age or older at the time of signed informed consent.\n* Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.\n* Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \\[LN\\]) that is amenable to serial RP2 injections.\n* Must be willing to provide tumor biopsy samples.\n* LDH ≤ 2 × upper limit of normal (ULN).\n* Has adequate hematologic, hepatic and renal function\n* Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \\[INR\\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n* Life expectancy of \\> 6 months as estimated by the Investigator.\n\nKey Exclusion Criteria:\n\n* Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.\n* Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.\n* Current active significant herpetic infections or prior complications of HSV-1 infection.\n* Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.\n* Major surgery ≤ 2 weeks prior to the first dose of study intervention.\n* Any bleeding, thrombotic and\u002For other event that places the patient at an unacceptable risk of complications of intratumoral therapy.\n* Active, known, or suspected autoimmune disease requiring systemic treatment.\n* Prior treatment with an oncolytic virus.\n* Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).\n* Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.\n* Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.\n* Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.\n\nAdditional inclusion\u002F exclusion criteria are outlined in the study protocol",{"count":48,"type":20},280,[50,23],"PHASE2","The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.",[53],"Metastatic Uveal Melanoma",[55,56,57,58,59,60,61,62,63,64],"Metastatic","Uveal","Melanoma","Nivolumab","Ipilimumab","Randomized","Immune checkpoint inhibitor-naïve","RP2","Oncolytic viruses","HSV-1","2026-03-31",{"date":67,"type":31},"2026-04-02",{"date":69,"type":31},"2024-12-17",{"date":71,"type":20},"2031-10",{"name":37,"class":38},33,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100495622","phase-2-study-of-rp2-in-combination-with-second-line-therapy-in-patients-with-locally-advanced-or-metastatic-hcc-100495622","NCT05733598","Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC","A Phase 2, Open-label, Multicenter Study Investigating RP2 Oncolytic Immunotherapy in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable, Recurrent and\u002For Metastatic Hepatocellular Carcinoma","Key Inclusion Criteria:\n\nI 1. Male or female ≥ 18 years of age. I 2. (HCC only) Has locally advanced unresectable, recurrent, and\u002For metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features or imaging criteria (using LI-RADS v2018; \\[Chernyak 2018\\]) according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis (Marrero 2018). Sites should select lesions that are either \"probable HCC - LIRADS 4\" or \"definite HCC - LIRADS 5\".\n\nI 3. (HCC only) Must have progressed while on first and only systemic therapy, which must have included anti PD-1 or anti-PD-L1 therapy (eg, atezolizumab plus bevacizumab combination, durvalumab plus tremelimumab combination, durvalumab, pembrolizumab, or nivolumab monotherapy or nivolumab in combination with ipilimumab) as their immediate prior treatment regimen.\n\nI 4. (HCC only) Child-Pugh A, determined within 14 days before first study treatment.\n\nI 5. Has at least 1 measurable tumor of ≥ 1 cm in longest diameter (or ≥ 1.5 cm shortest diameter for lymph nodes) as defined by RECIST 1.1.\n\nI 6. Has injectable tumor(s), which alone or in aggregate, total at least 1 cm in diameter.\n\nI 7. Must be willing to consent to provide fresh tumor biopsy sample or archival tumor biopsy sample obtained within 90 days before the first dose of study treatment.\n\nI 8. Has adequate hematologic function, including: White blood cell (WBC) count ≥ 2.0 × 109\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (without granulocyte-colony stimulating factor support); platelet count ≥ 75 × 109\u002FL (without transfusion); hemoglobin ≥ 8.5 g\u002FdL (may have received transfusions; however, patient must not be transfusion-dependent).\n\nI 9. Has adequate hepatic function including: total bilirubin ≤ 3.0 × upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 5.0 × ULN.\n\nI 10. Has adequate renal function, defined as serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL\u002Fminute (measured using Cockcroft-Gault formula).\n\nI 11. Serum albumin ≥ 2.8 g\u002FdL. I 12. Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \\[INR\\] ≤ 1.7) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n\nI 13. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\nI 14. Female and male patients who meet the following criteria:\n\n1. Female patients are eligible if not pregnant (see IC #15) or breastfeeding and if one of the following applies 1) is a woman of non-childbearing potential (WNCBP) OR 2) is a woman of childbearing potential and must agree to use a highly effective contraception method during the treatment period, and for at least (a) 90 days after the last dose of RP2 or (b) 5 months after the last dose of atezolizumab, or (c) 6 months after the last dose of bevacizumab, or (d) 90 days after the last dose of durvalumab, whichever is longer.\n2. Male patients are eligible to participate if they agree to the following during the study treatment period, and for at least 90 days after the last dose of RP2: refrain from donating fresh unwashed sperm plus either be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) OR must agree to use an external condom and also should advise their partner to use a highly effective method of contraception as a condom may break or leak.\n\nI 15. Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of β hCG within 72 hours before the first dose and a negative urine pregnancy test on Dose 1 Day 1.\n\nI 16. Capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form and in this protocol.\n\nI 17. (BTC only) Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma whose disease has not progressed following the concurrent treatment with gemcitabine, platinum containing chemotherapy, and checkpoint inhibitors.\n\nPatients must be on combination treatment with gemcitabine, platinum containing chemotherapy, and a checkpoint inhibitor for a minimum of 12 weeksand maximum of 24 weeks. After the last combination chemotherapy treatment (gemcitabine plus platinum chemotherapy), checkpoint inhibitor treatment must be limited to 2 doses (8 weeks).\n\nNote: Patients who develop toxicity and discontinue platinum containing chemotherapy per treating physicians may enroll into the trial as long as they receive gemcitabine and durvalumab for 12 weeks. SD or PR must be documented on at least 2 scans while on prior combination treatment; the second scan can be the same as the baseline scan.\n\nKey Exclusion Criteria:\n\nE 1. (HCC only) Child-Pugh B or C. E 2. (HCC only) Patients with untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high-risk for bleeding.\n\nNote: Note: All patients in Cohort 1a and 1b must undergo an esophagogastroduodenoscopy (EGD), and all varices (irrespective of size) must be assessed and treated regardless of grade before enrollment. Patients who have undergone endoscopic treatment of all known varices 90 days before initiation of study treatment do not need to repeat the procedure.\n\nNote: EGD is not required for patients in Cohort 2 (RP2 monotherapy). E 3. Significant bleeding event within the last 12 months that places the patient at unjustifiable risk for bleeding from intratumoral injection procedures, based on Investigator or interventional radiologist assessment.\n\nE 4. (HCC only) Macroscopic intravascular invasion into the hepatic and\u002For portal vein(s) (ie, no Vp4), , vena cava, and\u002For other major blood vessel, or into the common bile duct(s).\n\nE 5. (HCC only) Histologic evidence of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma with HCC, or other rare HCC variants.\n\nE 6. History of medically refractory hepatic encephalopathy and\u002For hepato-renal syndrome.\n\nE 7. Disease that is amenable to curative surgical and\u002For locoregional therapies.\n\nE 8. Presence of liver tumors that are estimated to invade more than one-third of the liver.\n\nE 9. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage within 7 days before enrollment.\n\nE 10. Hepatitis B virus (HBV) DNA \\> 500 IU\u002FmL obtained within 28 days prior to initiation of study treatment. Co-infection of HBV and hepatitis C virus (HCV) is not allowed.\n\nNote: Patients with HBV DNA ≤ 500 U\u002FmL are eligible to enroll in the study. Patients must be on anti-HBV treatment (per local standard care that do not have activity with HSV. Entecavir, tenofovir, telbivudine, lamivudine can be used. Anti-HBV treatment must be given for a minimum of 14 days prior to Week 1 Day 1 and must continue antiviral treatment for the length of the study.\n\nE 11. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.\n\nE 12. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).\n\nNote: Patients with sporadic cold sores may be enrolled if no active cold sores are present at the time of Dose 1 Day 1.\n\nE 13. Systemic infection requiring IV antibiotics or other serious infection within 14 days before dosing.\n\nE 14. Received a live vaccine within 28 days before the first dose of study treatment.\n\nE 15. Known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\nE 16. Prior malignancy, other than HCC and BTC, active within the previous 3 years, except for localized cancers that have apparently been cured or only required surveillance (eg. basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n\nE 17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment.\n\nNote: Patients who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent.\n\nE 18. Systemic anticancer therapies within 4 weeks of the first dose of study drug.\n\nNote: Patients must have recovered (to Grade ≤ 1 or baseline) from all AEs due to previous therapies. Patients with Grade ≤ 2 neuropathy may be eligible if approved by the Medical Monitor.\n\nE 19. Received radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities (except for radiation-induced xerostomia), not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.\n\nE 20. Received prior treatment with an oncolytic virus therapy. E 21. History of significant cardiac disease including myocarditis or congestive heart failure (defined as New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months of enrollment.\n\nE 22. Uncontrolled infection requiring intravenous antibiotics. E 23. History of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), non-infectious pneumonitis that required steroids, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\nNote: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\nE 24. Active tuberculosis. E 25. History or evidence of psychiatric, substance abuse, or any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.\n\nE 26. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.\n\nE 27. Active, known, or suspected autoimmune disease requiring systemic treatment.\n\nNote: Patients with type 1 diabetes mellitus and\u002For hypothyroidism requiring only hormone replacement, and\u002For with autoimmune skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, and\u002For prior non-serious autoimmune conditions not expected to recur are permitted to enroll.\n\nE 28. Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids within 14 days before Dose 1 Day 1.\n\nNote: Patients who require a brief course (≤ 7 days) of corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic corticosteroids are permitted, only if the dose does not exceed 10 mg\u002Fday prednisone equivalent.\n\nE 29. Sensitivity to any of the study interventions, or components or thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n\nE 30. History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T lymphocyte antigen 4 or anti-PD-1\u002Fanti-PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways \\[eg, CD40, 4 1BB\\]) except those that are unlikely to recur or are expected to be manageable with standard countermeasures (eg, hormone replacement after adrenal crisis). Individual cases should be discussed with Medical Monitor if needed.\n\nE 31. (HCC only) Current or recent (within 10 days of first dose of study treatment) use of aspirin or treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose.\n\nNote: Prophylactic anticoagulation for the patency of venous access devices is allowed.\n\nE 32. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks before treatment.\n\nE 33. Prior organ transplantation including allogeneic stem-cell transplantation.\n\nE 34. (HCC only) Major surgery within 28 days before starting bevacizumab or anticipated major surgery while on study.\n\nNote: If a patient received major surgery, they must have recovered adequately from the intervention before starting study treatment and must have adequate wound healing, based on Investigator's assessment or surgeon's assessment, before starting bevacizumab.\n\nE 35. (BTC only) Ampullary carcinoma or mixed cholangiocarcinoma with HCC. E 36. (BTC only) Patients with mismatch repair deficiency and microsatellite instability-high are excluded.","18 Years",{"count":83,"type":20},60,[50],"The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and\u002For metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC.",[87,88],"Hepatocellular Carcinoma","Biliary Tract Cancer",[90,87,91,88,92],"Oncolytic virus","HCC","BTC",{"date":67,"type":31},{"date":95,"type":31},"2024-08-01",{"date":97,"type":20},"2028-07-01",{"name":37,"class":38},12,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100584285","a-study-to-assess-the-long-term-safety-outcomes-in-patients-previously-treated-with-rp1-rp2-or-rp3-100584285","NCT06887348","A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3","Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products","RPx","Inclusion Criteria:\n\nPatients are eligible for inclusion in the study only if they meet all of the following criteria:\n\n1. Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.\n2. Patient or patient's legal guardian has provided signed informed consent (or assent) as , which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\nPatients are excluded from the study if the following criterion applies:\n\n1\\. Cannot comply with the requirements of the study.",{"count":109,"type":20},50,"OBSERVATIONAL","This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.",[57,113,114,87],"Metastatic Melanoma","Advanced Solid Tumor",[116,117,118,90,119,87,120,121,122,123],"Advanced solid tumors","Immunotherapy","Immuno-oncology","Oncolytic immuno-gene therapy","Cutaneous Melanoma","Anti-PD1 failed","Non-melanoma Skin Cancer","Melanoma (skin)","2026-01-09",{"date":126,"type":31},"2026-01-12",{"date":128,"type":31},"2025-12-12",{"date":130,"type":20},"2035-12",{"name":37,"class":38},2,""]