Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
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UCRecruiting

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

Phase 2 · Testing nivolumab and pembrolizumab · 1 site · Diwakar Davar

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing nivolumab (a drug) and pembrolizumab (a drug) as a possible treatment. Condition(s) listed: Renal Cell Carcinoma, Non Small Cell Lung Cancer and Melanoma.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Some of the main requirements, copied from the record:

Plus 13 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhasePhase 2
Study typeInterventional
ConditionsRenal 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
Lead sponsorDiwakar Davar
Enrollment880 (estimated)
Start date2025-11-04
Primary completion (est.)2030-11-30
First posted2025-10-31
Last updated2026-04-16
Official titlePatient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)
ClinicalTrials.gov IDNCT07223424

Interventions

Full eligibility criteria (from the record)
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.

Locations (1)

SiteCityCountrySite status
UPMC Hillman Cancer CenterPittsburgh, PennsylvaniaUnited StatesRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.