RightFit
RecruitingPhase 2

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study asks patients and health care staff whether they prefer immune therapy as a shot under the skin or through a vein (IV). It is for people with advanced solid tumors who can receive nivolumab or pembrolizumab.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can understand and agree to sign a form giving consent to join the study.
  • Can read and write in English.
  • Have a solid tumor that has grown nearby or spread to other parts of the body. Nivolumab or pembrolizumab must be approved for your cancer.
  • The study doctor must decide you can receive nivolumab or pembrolizumab, alone or with other approved cancer drugs.
  • Are new to this type of immune therapy, or are already getting it as your first treatment or as treatment after surgery.
  • If new to treatment, plan to start nivolumab or pembrolizumab. If already on treatment, receive one of these drugs or be willing to switch from a similar immune therapy.
  • If getting nivolumab with ipilimumab as your starting treatment, you may join after that phase. You cannot join if both drugs are planned together for ongoing treatment.
  • Cannot join while this immune therapy is planned before surgery. You may be considered when starting pembrolizumab treatment after surgery.

Who can't join

  • Cannot receive nivolumab or pembrolizumab because of a past allergic reaction to the drug or its ingredients.
  • Have had a severe allergic reaction to nivolumab, pembrolizumab, or their ingredients.
  • Have had a tissue or solid organ transplant from another person.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

PA