Study on Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

Sponsor: Diwakar Davar

Sponsor score: 0

ClinicalTrials ID:NCT07223424

Provider View

This study is exploring whether patients and healthcare professionals prefer immune therapy given as a shot under the skin (subcutaneous) or through a vein (intravenous) for the drugs nivolumab and pembrolizumab.

Patient Parameters

Program Overview

The study aims to find out if patients and healthcare providers prefer immune therapy drugs, nivolumab and pembrolizumab, to be given as a subcutaneous injection (under the skin) rather than the traditional intravenous (IV) method (through a vein). This could make treatment easier and less time-consuming for patients. The study will also look at doctors' experiences with both methods, how well the treatments work, and their safety. Patients who are about to start treatment with nivolumab or are willing to switch to it may join the study. If pembrolizumab gets approved for subcutaneous use, the study will also include patients using this drug.

Description

The study is designed to see if patients prefer receiving their immune therapy drugs, nivolumab and pembrolizumab, as a quick shot under the skin instead of through an IV drip. This could make treatment more convenient and less burdensome. The study will also gather feedback from doctors about their experiences with both methods and evaluate how effective and safe the treatments are.

Patients who are about to start treatment with nivolumab or are willing to switch to it can participate. If pembrolizumab is approved for subcutaneous use, patients using this drug will also be included. The study will have different groups for patients starting treatment and those already on treatment but willing to switch.

The U.S. FDA is reviewing an application for subcutaneous pembrolizumab, with a decision expected by September 23, 2025. If approved, the study will expand to include patients using pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and willing to sign a consent form.
  • Can read and write in English.
  • Eligible to receive nivolumab or pembrolizumab alone or with other approved treatments, as decided by the doctor.
  • Patients should either be new to immune therapy or currently receiving it and willing to switch to nivolumab or pembrolizumab.
  • Have a locally advanced or advanced/metastatic solid tumor for which nivolumab or pembrolizumab is approved.
  • Specific criteria for different groups:
    • Group A-1: New patients planning to start nivolumab.
    • Group B-1: Patients already on nivolumab or another immune therapy willing to switch to nivolumab.
    • Group A-2: New patients planning to start pembrolizumab.
    • Group B-2: Patients already on pembrolizumab or another immune therapy willing to switch to pembrolizumab.
    • Note: Patients on nivolumab + ipilimumab may join Group B-1 after initial treatment, except for certain conditions.
    • Note: Patients planning to use immune therapy before surgery are not eligible but may join after starting post-surgery treatment.

Exclusion Criteria

  • Cannot receive nivolumab or pembrolizumab due to past allergic reactions to these drugs or their ingredients.
  • Have had a severe allergic reaction (Grade 3 or higher) to nivolumab or pembrolizumab.
  • Have had a tissue or organ transplant from another person.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center15232PittsburghPennsylvania

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