Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

NCT07223424 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCC 25-125
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Preference for Subcutaneous Nivolumab Treatment

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

  Up to 48 months

• Preference for Subcutaneous Pembrolizumab Treatment

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

  Up to 48 months

Secondary Outcomes (12)

• Therapy Administration Satisfaction Questionnaire

  Up to 48 months

• Therapy Administration Satisfaction Questionnaire

  Up to 48 months

• Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30

  Screening Phase - Up to 28 days after signed consent

• Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30

  At Day 1 of Treatment Cycle 3

• Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30

  At Day 1 of Treatment Cycle 6

Study Arms (2)

Subcutaneous to IV

ACTIVE COMPARATOR

SC nivolumab (or pembrolizumab) x3 cycles followed by IV nivolumab (or pembrolizumab) x3 cycles.

Drug: nivolumab; Drug: pembrolizumab

IV to Subcutaneous

ACTIVE COMPARATOR

IV nivolumab (or pembrolizumab) x3 cycles followed by SC nivolumab (or pembrolizumab) x3 cycles

Drug: nivolumab; Drug: pembrolizumab

Interventions

nivolumab DRUG

IV nivolumab (480mg Q4W), SC nivolumab (1200mg Q4W)

Also known as: OPDIVO®

IV to Subcutaneous; Subcutaneous to IV

pembrolizumab DRUG

IV pembrolizumab (400mg Q6W) or SC pembrolizumab (790mg Q6W)

Also known as: Keytruda®

IV to Subcutaneous; Subcutaneous to IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diwakar Davar: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Melanoma; Colonic Neoplasms; Carcinoma, Hepatocellular; Colitis, Ulcerative; Esophageal Neoplasms; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Nivolumab; pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Liver Neoplasms; Liver Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Diwakar J Davar, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle L Bednarz, RN

CONTACT

4126231191; bednarzdl@upmc.edu

Amy Rose, RN

CONTACT

4126478587; kennaj@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 31, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)