Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- Diwakar Davar
- Study ID
- NCT07223424
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Cervical Cancer
- Colo-rectal Cancer (dMMR/MSI-H CRC)
- Esophageal Adenocarcinoma
- Esophageal Cancer
- Gastric/GEJ
- Gastro-Esophageal Adenocarcinoma
- Hepatocellular Carcinoma
- Melanoma
- Non Small Cell Lung Cancer
- Renal Cell Carcinoma
- Squamous Cell Carcinoma
- Ulcerative Colitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- nivolumab — DRUGIV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)
- pembrolizumab — DRUGIV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)
Study Details
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.
Key Dates
- First listed
- Oct 31, 2025
- Start date
- Nov 4, 2025
- Status verified
- Apr 2026
- Primary completion
- Nov 30, 2030
- Completion
- Nov 30, 2030
Study Design
- Enrollment
- 880 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Subcutaneous to IVSC nivolumab (or pembrolizumab) x3 cycles followed by IV nivolumab (or pembrolizumab) x3 cycles.
- Active Comparator: IV to SubcutaneousIV nivolumab (or pembrolizumab) x3 cycles followed by SC nivolumab (or pembrolizumab) x3 cycles
Primary Outcome Measure
Preference for Subcutaneous Nivolumab Treatment [ Time Frame: Up to 48 months ]
Central Contacts
- Danielle L Bednarz, RN4126231191
- Amy Rose, RN4126478587
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Diwakar J Davar, MD (PRINCIPAL_INVESTIGATOR) |
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