MelanomaPhase 3CheckMate-6GENCT05297565
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
A Phase 3 study testing Nivolumab/rHuPH20 and Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 16 sites in 7 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Nivolumab/rHuPH20 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 2 Aug 2022to 8 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
- Complete resection performed within 12 weeks prior to randomization or treatment assignment
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Who cannot join
- History of uveal or mucosal melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Serious or uncontrolled medical disorder 4 weeks prior to screening
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
- Prior immunotherapy treatments for any prior malignancies are not permitted
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Spain5 sites
Local Institution - 0026
Barcelona, 08003
Local Institution - 0002
Madrid, 28036
Local Institution - 0043
Madrid, 28050
Local Institution - 0005
Seville, 41009
Local Institution - 0030
Valencia, 46014
Australia3 sites
Local Institution - 0008
Bendigo, Victoria, 3550
Local Institution - 0038
Coffs Harbour, New South Wales, 2450
Local Institution - 0003
Wollongong, New South Wales, 2500
United States2 sites
Local Institution - 0004
Fort Wayne, Indiana, 46804
Local Institution - 0044
Knoxville, Tennessee, 37920
Italy2 sites
Local Institution - 0016
Milan, 20141
Local Institution - 0015
Naples, 80131
Poland2 sites
Local Institution - 0036
Bydgoszcz, 85-796
Local Institution - 0034
Opole, Opole Voivodeship, 45-061
United Kingdom1 site
Local Institution - 0040
Leicester, Leicestershire, LE1 5WW
About this study
Official title: A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab/rHuPH20Biological
Also called BMS-986298
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Subcutaneous Nivolumab | Experimental | Not described Receives: Biological: Nivolumab/rHuPH20 |
| Arm B: Intravenous Nivolumab | Active comparator | Not described Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
- Results in death.
- Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
- Requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Treatment Related Adverse Events
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment.
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.
Measured: From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Treatment Related Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
- Results in death.
- Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
- Requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose to 100 days post last dose (Approximately up to 14 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start2 Aug 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297565
- Sponsor's protocol ID
- CA209-6GE
- Other IDs
- 2021-003208-42, U1111-1266-6116
- Acronym
- CheckMate-6GE
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2022
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
- ClinicalTrials.gov ID
- NCT05297565
- Acronym / sponsor ID
- CheckMate-6GE / CA209-6GE
- Conditions
- Melanoma
- Keywords
- Skin Cancer, rHuPH20, OPDIVO®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Subcutaneous Nivolumab | Experimental | Biological: Nivolumab/rHuPH20 |
| Arm B: Intravenous Nivolumab | Active comparator | Biological: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
- Complete resection performed within 12 weeks prior to randomization or treatment assignment
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Key exclusion criteria (7 listed)
- History of uveal or mucosal melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Serious or uncontrolled medical disorder 4 weeks prior to screening
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab/rHuPH20Also: BMS-986298Specified dose on specified days | Biological | Arm A: Subcutaneous Nivolumab |
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Biological | Arm B: Intravenous Nivolumab |
Primary outcome
Number of Participants With Adverse Events
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants With Serious Adverse Events
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.
Number of Participants With Treatment Related Adverse Events
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.
Number of Participants With Treatment Related Serious Adverse Events
Time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab/rHuPH20 and Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, Australia, United States, Italy, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From first dose to 100 days post last dose (Approximately up to 14 Months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.