NCT07223424

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Diwakar Davar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma
• Non Small Cell Lung Cancer
• Melanoma
• Colo-rectal Cancer (dMMR/MSI-H CRC)
• Hepatocellular Carcinoma
• Ulcerative Colitis
• Esophageal Cancer
• Squamous Cell Carcinoma
• Gastric/GEJ
• Cervical Cancer
• Gastro-Esophageal Adenocarcinoma
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	nivolumab	IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)
DRUG	pembrolizumab	IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)

Timeline

• Start date: 2025-11-04
• Primary completion: 2030-11-30
• Completion: 2030-11-30
• First posted: 2025-10-31
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study