[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07223424":3,"trial-entities:NCT07223424":155,"trial-summary:NCT07223424":164},{"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":31,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":55,"secondary_outcomes":63,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":99,"eligibility_criteria":100,"std_ages":122,"locations":125,"central_contacts":148,"overall_officials":151,"references":153,"see_also_links":154},"NCT07223424","HCC 25-125","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","RECRUITING","2030-11-30","2026-04","2026-04-16","2025-11-04","Diwakar Davar","OTHER",true,"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.","The development of SC nivolumab and SC pembrolizumab was intended to provide patients, physicians and health care systems compelling advantages to reduce the burden associated with ICI administration. However, despite the results of CheckMate 76K, Hillman Cancer Center utilization of SC nivolumab is poor. This study aims to formally assess, from the patients' perspective, whether SC administration of ICI agents is preferable to IV administration. Key secondary objectives include physician experience with SC vs. IV administration, cancer-related efficacy endpoints, and safety. Patients who are pending initiation of nivolumab monotherapy or nivolumab-based chemotherapy or targeted therapy combinations (Cohort A-1) will be enrolled. However, patients who are already receiving nivolumab or other ICI but are willing to be switched to nivolumab monotherapy or nivolumab-based combinations may be eligible to enroll in a separate cohort (Cohort B-1). US FDA has accepted a Biologics License Application from Merck for SC pembrolizumab for an FDA action date of 9\u002F23\u002F2025. Should SC pembrolizumab achieve FDA approval, we will aim to open 2 separate cohorts to evaluate patient preference for SC vs. IV pembrolizumab.",[19,20,21,22,23,24,25,26,27,28,29,30],"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",[],"INTERVENTIONAL","TREATMENT",[35],"PHASE2",{"count":37,"type":38},880,"ESTIMATED",[40,49],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":47},"DRUG","nivolumab","IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)",[45,46],"IV to Subcutaneous","Subcutaneous to IV",[48],"OPDIVO®",{"type":41,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"pembrolizumab","IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)",[45,46],[54],"Keytruda®",[56,60],{"measure":57,"description":58,"timeFrame":59},"Preference for Subcutaneous Nivolumab Treatment","The proportion of patients with locally advanced or advanced\u002Fmetastatic solid tumors who prefer SC to IV nivolumab.","Up to 48 months",{"measure":61,"description":62,"timeFrame":59},"Preference for Subcutaneous Pembrolizumab Treatment","The proportion of patients with locally advanced or advanced\u002Fmetastatic solid tumors who prefer SC to IV pembrolizumab.",[64,67,69,73,76,78,82,85,86,87,90,93],{"measure":65,"description":66,"timeFrame":59},"Therapy Administration Satisfaction Questionnaire","Patient assessed satisfaction with SC vs. IV nivolumab (or pembrolizumab) using Therapy Administration Satisfaction Questionnaire (using TASQ-IV) in patients with locally advanced or advanced\u002Fmetastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations.",{"measure":65,"description":68,"timeFrame":59},"Patient assessed satisfaction with SC vs. IV nivolumab (or pembrolizumab) using Therapy Administration Satisfaction Questionnaire (using TASQ-SC) in patients with locally advanced or advanced\u002Fmetastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations.",{"measure":70,"description":71,"timeFrame":72},"Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30","Patient reported HRQoL scores using the EORTC QLQ-C30 instrument. The categories\u002Fdomains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale. Item scoring for functional items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores (all items) range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.","Screening Phase - Up to 28 days after signed consent",{"measure":70,"description":74,"timeFrame":75},"Patient reported HRQoL scores using the EORTC QLQ-C30 instrument (30 items). The categories\u002Fdomains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), and global health status and quality of life scale. Item scoring for functional and symptom items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.","At Day 1 of Treatment Cycle 3",{"measure":70,"description":74,"timeFrame":77},"At Day 1 of Treatment Cycle 6",{"measure":79,"description":80,"timeFrame":81},"Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30","Changes in patient reported HRQoL scores using the EORTC QLQ-C30 instrument. The categories\u002Fdomains include functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), and global health status and quality of life scale. Item scoring for functional and symptom items is 1 (Not at all) to 4 (Very much); Item scoring for global health items is 1 (Very poor) to 7 (Excellent). Total scores range from 0 to 100. For functional and global quality of life scales higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.","Up to 48 nmonths",{"measure":83,"description":84,"timeFrame":72},"Health Related Quality of Life (HRQoL) - EQ-5D-5L","Patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.",{"measure":83,"description":84,"timeFrame":75},{"measure":83,"description":84,"timeFrame":77},{"measure":88,"description":89,"timeFrame":59},"Change Health Related Quality of Life (HRQoL) - EQ-5D-5L","Change in patient reported HRQoL scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.",{"measure":91,"description":92,"timeFrame":59},"Physician-defined TTNT","Physician-defined time to next therapy (TTNT) is defined as the period from the start of the treatment to the start of the next line of treatment.",{"measure":94,"description":95,"timeFrame":59},"Incidence of irAEs","Incidence of immune-related adverse events (irAEs) that result in a dose hold or delay in patients treated with either SC or IV nivolumab (or pembrolizumab) per Common Terminology Criteria for Adverse Events (CTCAE) guidelines v5","ALL","18 Years",null,false,{"inclusion":101,"exclusion":117,"raw_text":121},[102,103,104,105,106,107,108,109,110,111,112,113,114,115,116],"Able to understand and willing to sign a written informed consent document.","Able to read and write in English.","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.","Prior and concurrent therapy criteria","Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.","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).","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).","Cohort-specific criteria.","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.","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.","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.","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.","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.","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).","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.",[118,119,120],"Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.","Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.","Has had an allogenic tissue\u002Fsolid organ transplant.","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.",[123,124],"ADULT","OLDER_ADULT",[126],{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":131,"contacts":132,"geoPoint":145},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232","United States",[133,138,142],{"name":134,"role":135,"phone":136,"email":137},"Danielle L Bednarz, RN","CONTACT","4126231191","bednarzdl@upmc.edu",{"name":139,"role":135,"phone":140,"email":141},"Amy Rose, RN","4126478587","kennaj@upmc.edu",{"name":143,"role":144},"Diwakar J Davar, MD","PRINCIPAL_INVESTIGATOR",{"lat":146,"lon":147},40.44062,-79.99589,[149,150],{"name":134,"role":135,"phone":136,"email":137},{"name":139,"role":135,"phone":140,"email":141},[152],{"name":143,"affiliation":127,"role":144},[],[],{"nct_id":4,"conditions":156,"biomarkers":163},[157,158,30,159,160,23,161,21,19,162,26,24],"Cervical Carcinoma","Colorectal Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Lung Non-Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":165,"prompt_version":174},{"design":166,"status":167,"heading":6,"summary":168,"follow_up":169,"word_count":170,"commitments":171,"compensation":172,"drugs_mentioned":173},"This is an interventional study planning to enroll 880 participants. It will compare patient and healthcare professional preferences for subcutaneous versus intravenous administration of nivolumab or pembrolizumab.","completed","This study is looking at whether patients prefer receiving their immune therapy medication as an injection under the skin (subcutaneous, or SC) compared to through a vein (intravenous, or IV). The medications being studied are nivolumab and pembrolizumab, which are used to treat certain cancers like renal cell carcinoma (kidney cancer), non-small cell lung cancer, melanoma, and colorectal cancer. Researchers want to understand if patients find the SC method more convenient or comfortable. You might be able to join if you are 18 or older, can read and write in English, and are eligible to receive nivolumab or pembrolizumab for your cancer, either alone or with other approved treatments. The main goal is to see patient preference for SC nivolumab or pembrolizumab over a period of up to 48 months. The study is currently unclear on its recruitment status.","Patient preference will be measured for up to 48 months after starting treatment.",139,"Not specified in the trial record.","Not stated in the trial record.",[42,50],"v2"]