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Recruiting Phase 2

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

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About this study

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.

Condition
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
Tested
nivolumab, pembrolizumab
Sponsor
Diwakar Davar

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 18

  • Minimum age: 18 years
  • Study condition: 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
  • 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 3

  • 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

1 site, 1 recruiting

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.