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.
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
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/or any of its excipients.
Has had an allogenic tissue/solid organ transplant.
Crossover
nivolumab
DrugIV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)
pembrolizumab
DrugIV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)
Preference for Subcutaneous Nivolumab Treatment
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV nivolumab.
Preference for Subcutaneous Pembrolizumab Treatment
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV pembrolizumab.
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/metastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations.
Therapy Administration Satisfaction Questionnaire
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/metastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations.
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Patient reported HRQoL scores using the EORTC QLQ-C30 instrument. The categories/domains 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.
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Patient reported HRQoL scores using the EORTC QLQ-C30 instrument (30 items). The categories/domains 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.
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Diwakar Davar
Lead sponsor
University of Pittsburgh
Sponsor institution
