[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":67,"collaborators":43,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":43,"enrollmentInfo":81,"targetDuration":43,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":43,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Subcutaneous to IV","ACTIVE_COMPARATOR","SC nivolumab (or pembrolizumab) x3 cycles followed by IV nivolumab (or pembrolizumab) x3 cycles.",[13,14],"Drug: nivolumab","Drug: pembrolizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"IV to Subcutaneous","IV nivolumab (or pembrolizumab) x3 cycles followed by SC nivolumab (or pembrolizumab) x3 cycles",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","nivolumab","IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)",[16,9],[26],"OPDIVO®",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"pembrolizumab","IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)",[16,9],[32],"Keytruda®",[34],{"name":35,"affiliation":36,"role":37},"Diwakar J Davar, MD","UPMC Hillman Cancer Center","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Danielle L Bednarz, RN","CONTACT","4126231191",null,"bednarzdl@upmc.edu",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Amy Rose, RN","4126478587","kennaj@upmc.edu",[50],{"facility":36,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Pittsburgh","Pennsylvania","15232","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-79.99589,40.44062,{"lat":61,"lon":60},[64,65,66],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},{"name":35,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Diwakar Davar","Associate Professor of Medicine","100610118","phase-2-patient-preference-for-subcutaneous-vs-intravenous-immune-therapy-100610118",false,"NCT07223424","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","PSI-Immune","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document.\n* Able to read and write in English.\n* Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.\n* Prior and concurrent therapy criteria\n\n  o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).\n* Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.\n\n  * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric\u002FGEJ).\n  * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, gastric\u002FGEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).\n* Cohort-specific criteria.\n\n  * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.\n  * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.\n  * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced\u002Fmetastatic melanoma, ccRCC, MSI-H\u002FdMMR mCRC.\n  * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).\n  * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.\n\nExclusion Criteria:\n\n* Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":82,"type":83},880,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.",[89,90,91,92,93,94,95,96,97,98,99,100],"Renal Cell Carcinoma","Non Small Cell Lung Cancer","Melanoma","Colo-rectal Cancer (dMMR\u002FMSI-H CRC)","Hepatocellular Carcinoma","Ulcerative Colitis","Esophageal Cancer","Squamous Cell Carcinoma","Gastric\u002FGEJ","Cervical Cancer","Gastro-Esophageal Adenocarcinoma","Esophageal Adenocarcinoma","2026-04-13",{"date":103,"type":104},"2026-04-16","ACTUAL",{"date":106,"type":104},"2025-11-04",{"date":108,"type":83},"2030-11-30",{"name":69,"class":6},1]