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Checkpoint Inhibitor

Subcutaneous vs Intravenous Nivolumab for Melanoma (CheckMate-6GE Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IIIA/B/C/D or Stage IV melanoma with histologically confirmed completely surgically resected melanoma with negative margins
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Must not have
History of uveal or mucosal melanoma
Untreated/unresected CNS metastases or leptomeningeal metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares levels of a melanoma drug when given subcutaneously (under the skin) versus intravenously (into a vein).

Who is the study for?
This trial is for individuals who have had surgery to remove Stage IIIA/B/C/D or Stage IV melanoma and are in good physical condition (ECOG ≤ 1). They must have had the surgery within the last 12 weeks. People with a history of certain types of melanoma, untreated brain metastases, active autoimmune diseases, serious medical conditions, or other cancers treated within the last two years cannot join.
What is being tested?
The study is testing how safe and tolerable it is to receive Nivolumab through a shot under the skin compared to getting it through an IV. This involves people who've just had their melanoma surgically removed and aims to see which method works best following resection.
What are the potential side effects?
Nivolumab can cause immune-related side effects such as inflammation in various organs like lungs or intestines, skin rash, hormone gland problems (like thyroid), fatigue, infusion reactions if given intravenously, and potential injection site reactions if given subcutaneously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma was surgically removed with clear margins.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had melanoma in my eye or mucous membranes.
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I have brain or spinal cord metastases that haven't been treated or removed.
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I have an autoimmune disease.
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I have never received immunotherapy for any cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Maximum nivolumab serum concentration after the first dose (Cmax1)
Maximum nivolumab serum concentration at steady-state (Cmaxss)
Mean CTSQ Satisfaction domain score change from baseline at each assessment time point
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Subcutaneous NivolumabExperimental Treatment1 Intervention
Group II: Arm B: Intravenous NivolumabActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab/rHuPH20
2022
Completed Phase 3
~20

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,999 Total Patients Enrolled
179 Trials studying Melanoma
57,701 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05297565 — Phase 3
Melanoma Research Study Groups: Arm A: Subcutaneous Nivolumab, Arm B: Intravenous Nivolumab
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05297565 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05297565 — Phase 3
~4 spots leftby Nov 2025
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