Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)
Summary
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.
Detailed description
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 9/23/2025. Should SC pembrolizumab achieve FDA approval, we will aim to open 2 separate cohorts to evaluate patient preference for SC vs. IV pembrolizumab.
Arms & interventions
- Drugnivolumab
IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)
- Drugpembrolizumab
IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)
Outcome measures
Primary
Preference for Subcutaneous Nivolumab Treatment
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV nivolumab.
Time frame: Up to 48 months
Preference for Subcutaneous Pembrolizumab Treatment
The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV pembrolizumab.
Time frame: Up to 48 months
Secondary
Therapy Administration Satisfaction Questionnaire
Time frame: Up to 48 months
Therapy Administration Satisfaction Questionnaire
Time frame: Up to 48 months
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: Screening Phase - Up to 28 days after signed consent
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: At Day 1 of Treatment Cycle 3
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: At Day 1 of Treatment Cycle 6
Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Time frame: Up to 48 nmonths
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: Screening Phase - Up to 28 days after signed consent
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: At Day 1 of Treatment Cycle 3
Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: At Day 1 of Treatment Cycle 6
Change Health Related Quality of Life (HRQoL) - EQ-5D-5L
Time frame: Up to 48 months
Physician-defined TTNT
Time frame: Up to 48 months
Incidence of irAEs
Time frame: Up to 48 months
Eligibility criteria
Study locations (1)
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232