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A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (CheckMate-6GE)

Primary Purpose

Melanoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab/rHuPH20
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Skin Cancer, rHuPH20, OPDIVO®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Local Institution - 0004
  • Local Institution - 0044
  • Local Institution - 0038
  • Local Institution - 0003
  • Local Institution - 0008
  • Local Institution - 0029
  • Local Institution - 0016
  • Local Institution - 0015
  • Local Institution - 0034
  • Local Institution - 0036
  • Local Institution - 0026
  • Local Institution - 0002
  • Local Institution - 0043
  • Local Institution - 0005
  • Local Institution - 0030
  • Local Institution - 0040

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Subcutaneous Nivolumab

Arm B: Intravenous Nivolumab

Arm Description

Outcomes

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
Number of participants with treatment-related SAEs

Secondary Outcome Measures

Full Information

First Posted
March 17, 2022
Last Updated
August 18, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05297565
Brief Title
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Acronym
CheckMate-6GE
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Skin Cancer, rHuPH20, OPDIVO®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Subcutaneous Nivolumab
Arm Type
Experimental
Arm Title
Arm B: Intravenous Nivolumab
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Nivolumab/rHuPH20
Other Intervention Name(s)
BMS-986298
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 15 months
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 15 months
Title
Number of participants with treatment-related AEs
Time Frame
Up to 15 months
Title
Number of participants with treatment-related SAEs
Time Frame
Up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0004
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Local Institution - 0044
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Local Institution - 0038
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Local Institution - 0003
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Local Institution - 0008
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
Local Institution - 0029
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0016
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution - 0015
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0034
City
Opole
State/Province
Opolskie
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Local Institution - 0036
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0026
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution - 0002
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Local Institution - 0043
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Local Institution - 0005
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Local Institution - 0030
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution - 0040
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

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