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Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

This study is looking at whether patients prefer receiving their immune therapy medication as an injection under the skin (subcutaneous, or SC) compared to through a vein (intravenous, or IV). The medications being studied are nivolumab and pembrolizumab, which are used to treat certain cancers like renal cell carcinoma (kidney cancer), non-small cell lung cancer, melanoma, and colorectal cancer. Researchers want to understand if patients find the SC method more convenient or comfortable. You might be able to join if you are 18 or older, can read and write in English, and are eligible to receive nivolumab or pembrolizumab for your cancer, either alone or with other approved treatments. The main goal is to see patient preference for SC nivolumab or pembrolizumab over a period of up to 48 months. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 880 participants. It will compare patient and healthcare professional preferences for subcutaneous versus intravenous administration of nivolumab or pembrolizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Patient preference will be measured for up to 48 months after starting treatment.

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NCT07223424

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Diwakar Davar
~880 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:nivolumabpembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Preference for Subcutaneous Nivolumab Treatment
Measured over Up to 48 months
+1 more outcome measured

Conditions

Renal 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

Explore related trials

Cervical CarcinomaColorectal CarcinomaEsophageal AdenocarcinomaEsophageal CarcinomaGastric CarcinomaHepatocellular CarcinomaLung Non-Small Cell CarcinomaMelanomaRenal Cell CarcinomaSolid NeoplasmSquamous Cell CarcinomaUlcerative Colitis

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Diwakar J Davar, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Danielle L Bednarz, RN
[email protected]
4126231191
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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • Preference for Subcutaneous Nivolumab TreatmentUp to 48 months

    The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV nivolumab.

  • Preference for Subcutaneous Pembrolizumab TreatmentUp to 48 months

    The proportion of patients with locally advanced or advanced/metastatic solid tumors who prefer SC to IV pembrolizumab.