Actively Recruiting
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
Led by Diwakar Davar · Updated on 2026-04-16
880
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign a written informed consent document.
- Able to read and write in English.
- Eligible to receive nivolumab or pembrolizumab alone or with other FDA-approved therapies as per investigator judgment.
- Patients must be either immune checkpoint inhibitor (ICI) naive or currently receiving PD-(L)1 based therapy alone or in combination with other FDA-approved agents.
- Have locally advanced or metastatic solid tumor for which nivolumab or pembrolizumab is FDA-approved.
- Cohort A-1: Treatment-naive patients planning to start nivolumab.
- Cohort B-1: Patients currently on or willing to switch to nivolumab monotherapy or combinations if on-label.
- Cohort A-2: Treatment-naive patients planning to start pembrolizumab.
- Cohort B-2: Patients currently on or willing to switch to pembrolizumab monotherapy or combinations if on-label.
- Patients receiving nivolumab plus ipilimumab combination as induction may enroll in Cohort B-1 during maintenance.
- Patients planned for nivolumab plus ipilimumab maintenance are not eligible.
- Patients planned for anti-PD-1 neoadjuvant therapy are not eligible but may enroll at adjuvant therapy start.
You will not qualify if you...
- Unable to receive nivolumab or pembrolizumab due to prior allergic reactions to these drugs or their ingredients.
- Experienced severe hypersensitivity (Grade 3 or higher) to nivolumab or pembrolizumab or any excipients.
- History of allogenic tissue or solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Danielle L Bednarz, RN
CONTACT
A
Amy Rose, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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