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Checkpoint Inhibitor

Health services research (in-clinic and at-home nivolumab) for Colorectal Cancer

Phase 2

Recruiting

Led By Roxana S Dronca

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently FDA approved and recommended by treating oncologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year post study completion

Awards & highlights

Study Summary

This trial compares giving a drug called nivolumab under the skin in a home setting versus in a clinic for cancer patients. Patients often have to spend a lot of time away from home for treatment

Who is the study for?

This trial is for patients with various cancers, including kidney, skin, lung, and others. It's designed for those who may benefit from receiving treatment at home due to difficulties traveling to medical facilities or a preference for the comfort of their own environment.Check my eligibility

What is being tested?

The study compares subcutaneous Nivolumab administration at home versus in a clinic setting. The focus is on how this affects cancer care quality and patient quality of life. It's a phase II trial that explores whether home treatment can be as safe and effective as clinic-based care.See study design

What are the potential side effects?

While specific side effects are not listed here, Nivolumab generally can cause immune-related reactions affecting different organs, fatigue, rash, infusion-related reactions and potential complications from injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer type is approved for nivolumab treatment by the FDA.

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I am willing to switch to injections for my treatment.

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I am moving to nivolumab alone after finishing treatment with both Ipilimumab and nivolumab.

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I am fully active or can carry out light work.

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My kidney function, measured by creatinine, is within normal limits.

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I live within 35 miles of the clinic or in its service area.

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I am not pregnant and will use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year post study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year post study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year post study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks

Secondary outcome measures

Emergency room visits and hospitalizations

Incidence of Adverse Events (AEs)

Overall survival (OS)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Health services research (in-clinic and at-home nivolumab)Experimental Treatment4 Interventions

Patients receive nivolumab SC on day 1 of each cycle. Cycles repeat every 28 days in clinic for 2 cycles, then at home by a HHNP for 4 cycles, followed by either in-clinic or at-home administration for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive in-home visits by a home health nurse and undergo remote patient monitoring including vital sign measurements and condition-specific symptom assessments throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Patient Monitoring

2019

N/A

~10

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,238 Total Patients Enrolled

Roxana S DroncaPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

12 Total Patients Enrolled

Roxana S. Dronca, M.D.Principal InvestigatorMayo Clinic

2 Previous Clinical Trials

212 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this research study?

"Per the data on clinicaltrials.gov, recruitment for this study is currently closed. The trial was initially listed on February 15th, 2024 and last updated on February 9th, 2024. Despite its closure to new participants, there are a staggering total of 6676 other active trials seeking enrollees at present."

Answered by AI

Has the FDA granted approval for health services research involving nivolumab administered both in clinical settings and at home?

"The safety evaluation conducted by our team at Power for the health services research involving in-clinic and at-home administration of nivolumab resulted in a rating of 2. This assessment is due to the trial being categorized as Phase 2, where there exists preliminary data supporting safety measures but no evidence yet backing its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program

2024. "Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265285.