[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06887348":3,"trial-entities:NCT06887348":101,"trial-summary:NCT06887348":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":36,"interventions":39,"primary_outcomes":48,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":34,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":92,"overall_officials":98,"references":99,"see_also_links":100},"NCT06887348","RPL-123-01","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","RECRUITING","2035-12","2026-01","2026-01-12","2025-12-12","Replimune, Inc.","INDUSTRY",false,"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.","Long-term outcomes include detection of delayed adverse event(s) for any new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorder, rheumatologic or other autoimmune disorder, hematologic disorder, new incidence of infection related to RPx product and new incidence of herpetic-like infection. Patients with a suspected herpetic infection will be asked to provide a sample of the area of the suspected infection (using a swab), and also may be asked to provide additional biological samples (eg, a blood or urine sample to determine presence of RPx.) No study interventions will be administered in this observational study. Patients will be contacted by telephone every 3 months (Q3M) for 5 years from enrollment on this study. Participant visits may occur in person, over the phone, by video conference, or other technology.",[19,20,21,22],"Melanoma","Metastatic Melanoma","Advanced Solid Tumor","Hepatocellular Carcinoma",[24,25,26,27,28,22,29,30,31,32],"Advanced solid tumors","Immunotherapy","Immuno-oncology","Oncolytic virus","Oncolytic immuno-gene therapy","Cutaneous Melanoma","Anti-PD1 failed","Non-melanoma Skin Cancer","Melanoma (skin)","OBSERVATIONAL",null,[],{"count":37,"type":38},50,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"OTHER","Observational study with no interventions","This is an observational study and there will be no clinical interventions.",[45],"Patients who received at least 1 dose of an RPx [RP1, RP2, RP3]",[47],"Observational Study",[49,52,54],{"measure":50,"timeFrame":51},"Evaluate the long-term safety of patients treated with an RPx product","Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks",{"measure":53,"timeFrame":51},"Identify any delayed adverse event(s) related to treatment with an RPx product",{"measure":55,"timeFrame":51},"Identify systemic HSV-1 infection related to treatment with an RPx product",[],"ALL","18 Years",{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"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.",[64,65],"ADULT","OLDER_ADULT",[67,80],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":77},"UC San Diego Moores Cancer Center","La Jolla","California","92093-0698","United States",[74],{"name":75,"role":76},"Soo Park, MD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},32.84727,-117.2742,{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":89},"Tasman Oncology Research","Southport","Queensland","4215","Australia",[87],{"name":88,"role":76},"Andrew Hill, MD",{"lat":90,"lon":91},-27.96724,153.39796,[93],{"name":94,"role":95,"phone":96,"email":97},"Clinical Trials at Replimune","CONTACT","1-781-222-9570","Clinicaltrials@replimune.com",[],[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[22,19,103],"Solid Neoplasm",[],{"nct_id":4,"found":106,"summary":107,"prompt_version":117},true,{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an observational study with no specified phase, planning to enroll 50 participants. It is not randomized or blinded.","completed","Long-term Safety Study of RP1, RP2, or RP3","This study is looking at the long-term safety of treatments called RP1, RP2, or RP3. It's for people who have already received at least one dose of one of these treatments in a previous study. The study aims to see if there are any delayed side effects, including new cancers, nerve problems, autoimmune disorders, blood problems, or infections related to the treatment, over a period of five years. This is an observational study, meaning you won't receive any new treatments. The study is currently unclear on its recruitment status and plans to include about 50 participants.","Participants will be followed for five years from enrollment to assess potential delayed risks.",96,"You will be contacted by telephone every three months for five years. These contacts may also occur in person, by video conference, or other technology.","Not stated in the trial record.",[],"v2"]