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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
CheckMate-6GE 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.Check my eligibility
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.See study design
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.
CheckMate-6GE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma was surgically removed with clear margins.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
CheckMate-6GE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with treatment-related AEs
+1 moreSecondary outcome measures
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 moreCheckMate-6GE 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
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,500 Total Patients Enrolled
177 Trials studying Melanoma
57,529 Patients Enrolled for Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all my pre-disease activities without restriction.I have an autoimmune disease.I have had melanoma in my eye or mucous membranes.I had surgery to remove my cancer within the last 12 weeks.I have not had any serious or uncontrolled health issues in the last 4 weeks.I have brain or spinal cord metastases that haven't been treated or removed.I have never received immunotherapy for any cancer.I have no active cancers besides early skin cancer or treated in situ cancers.My melanoma was surgically removed with clear margins.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Subcutaneous Nivolumab
- Group 2: Arm B: Intravenous Nivolumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Nivolumab/rHuPH20 for public use?
"Nivolumab/rHuPH20 is considered safe by our team at Power. This is a Phase 3 trial, so while there is only some data supporting efficacy, there are multiple rounds of data that support safety."
Answered by AI
Are there any volunteer openings left for this experiment?
"According to the website, this study is still looking for participants. The listing was created on September 2nd, 2020 and last updated on November 7th, 2020."
Answered by AI
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