Study Comparing In-Home and In-Clinic Administration of Nivolumab for Cancer Patients

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06265285

Provider View

This clinical trial is exploring whether receiving the cancer treatment nivolumab at home is as effective and comfortable as receiving it in a clinic. The study aims to see if home treatment can improve quality of life by reducing the burden of travel and time spent away from home.

Patient Parameters

Program Overview

This study is investigating the effects of administering the cancer drug nivolumab at home compared to in a clinic. The goal is to see if home treatment can be as safe and effective as clinic treatment while improving the quality of life for patients by allowing them to stay in their familiar home environment. This could be especially beneficial for patients who live far from treatment centers or have difficulty traveling.

Description

Primary Objective:

  • To compare patient experiences with cancer care when receiving nivolumab at home versus in a clinic over an 8-week period.

Secondary Objectives:

  • To find out if patients prefer receiving treatment at home or in a clinic.
  • To track changes in patients' health and quality of life over time.
  • To monitor any symptoms reported by patients.
  • To ensure the safety of home-administered treatment with remote monitoring.
  • To record any emergency room visits or hospital stays during the study.
  • To track overall survival rates for up to one year.

Tertiary Objective:

  • To evaluate the costs associated with receiving treatment at home versus in a clinic.

Study Outline:

Participants will receive nivolumab injections every 28 days. Initially, treatment will be given in a clinic for two cycles, then at home for four cycles, and finally, patients can choose to continue treatment either at home or in the clinic for up to one year, as long as the cancer does not progress and side effects are manageable. Home treatments will be supported by a nurse and remote monitoring of vital signs and symptoms. After completing the study treatment, follow-up visits will occur at 30 and 100 days, then every three months for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed cancer diagnosis for which nivolumab is approved and recommended by a doctor.
  • Willing to switch from intravenous to subcutaneous nivolumab.
  • Have recovered from previous cancer treatments.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Meet specific blood test criteria for liver and kidney function.
  • Live within 35 miles of the clinic or within the service area.
  • Have Wi-Fi at home for remote monitoring.
  • Agree to participate and follow study procedures.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.

Exclusion Criteria

  • Receiving other cancer treatments not part of the study.
  • Require constant assistance with daily activities.
  • Have severe health conditions that could interfere with the study.
  • Have uncontrolled illnesses or infections.
  • Have active autoimmune diseases requiring treatment.
  • Have another active cancer or history of cancer within the last two years, except for certain skin cancers.
  • Have had organ or stem cell transplants.
  • Have active brain metastases, unless stable and treated.
  • Pregnant or breastfeeding.
  • Have received live vaccines recently.
  • Have certain viral infections like active hepatitis B or C, or uncontrolled HIV.
  • Have allergies to study drug components.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.