Subcutaneous versus intravenous immune therapy: which do patients prefer?
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)
This project will test whether patients with advanced cancers prefer subcutaneous (under‑the‑skin) versus intravenous nivolumab or, if available, pembrolizumab.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 880 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, ipilimumab, chemotherapy, immunotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07223424 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional effort compares patient- and clinician-reported preference for subcutaneous (SC) versus intravenous (IV) administration of anti–PD‑1 antibodies, using nivolumab now and planning cohorts for pembrolizumab if its SC formulation is approved. Participants will be enrolled into cohorts for ICI‑naïve patients starting nivolumab (Cohort A‑1) and patients already on PD-(L)1 therapy who may switch to nivolumab (Cohort B‑1), with analogous cohorts planned for pembrolizumab pending FDA action. The primary outcome is patient preference between SC and IV delivery, with key secondary endpoints including physician experience, safety, and cancer-related efficacy measures. Procedures follow standard-of-care dosing with informed consent, administration of the assigned formulation, and follow-up for adverse events and treatment outcomes.
Who should consider this trial
Good fit: Adults with locally advanced or metastatic cancers for which nivolumab or pembrolizumab is on-label who can consent, read English, and are either ICI‑naïve or currently receiving PD-(L)1 therapy and willing to switch are ideal candidates.
Not a fit: Patients who are not eligible for nivolumab/pembrolizumab, cannot receive subcutaneous injections for medical reasons, are unable to travel to the Pittsburgh site, or cannot read English are unlikely to benefit.
Why it matters
Potential benefit: If successful, SC dosing could shorten clinic visits, reduce infusion-related burden, and improve convenience for patients and health systems.
How similar studies have performed: Prior work such as CheckMate 76K showed promising results for SC nivolumab but real-world uptake has been limited, and SC pembrolizumab remains pending FDA approval.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand and willing to sign a written informed consent document. * Able to read and write in English. * Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator. * Prior and concurrent therapy criteria o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2). * Locally advanced or advanced/metastatic solid tumor for which nivolumab OR pembrolizumab is on-label. * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR/MSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric/GEJ). * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR/MSI-H CRC, HCC, esophageal cancer, gastric/GEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC). * Cohort-specific criteria. * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll. * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer. * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll. * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer. * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced/metastatic melanoma, ccRCC, MSI-H/dMMR mCRC. * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA). * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate. Exclusion Criteria: * Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients. * Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and/or any of its excipients. * Has had an allogenic tissue/solid organ transplant.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Diwakar J Davar, MD — UPMC Hillman Cancer Center
- Study coordinator: Danielle L Bednarz, RN
- Email: bednarzdl@upmc.edu
- Phone: 4126231191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.