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Checkpoint Inhibitor

Nivolumab for 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

Must not have

Co-morbid systemic illnesses or severe concurrent disease

Uncontrolled intercurrent illness including infections, heart failure, unstable angina, cardiac arrhythmia, recent myocardial infarction, wound healing disorder, psychiatric illness/social situations affecting compliance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year post study completion

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses besides my current condition.

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I do not have any severe illnesses or social situations that could affect my treatment.

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I do not have any other cancers needing treatment or any active within the last 2 years.

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I have had an organ transplant or received stem cells or bone marrow from a donor.

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I expect to have major surgery while on the study treatment.

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I am on steroids or immunosuppressants for my condition.

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I need help all day with my daily activities.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Emergency room visits and hospitalizations

Incidence of Adverse Events (AEs)

Overall survival (OS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010

Patient Monitoring

2019

N/A

~10