CheckMate-6GE: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 6GE
Research type
Research Study
Full title
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants with Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
IRAS ID
1004989
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2021-003208-42
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to compare Nivolumab administered subcutaneously (under the skin) through a device called an autoinjector (Nivo SC AI) versus Nivolumab administered via infusion into a vein (Nivo IV). The duration of the study is about 3 years. The study will determine how the drug is absorbed, distributed, metabolised and eliminated from the body and also see how well the drug works, if the drug is safe and it can be tolerated.
Nivolumab is a human monoclonal antibody. An antibody is a type of protein that your immune system uses to find and destroy infections and potentially harmful cells (e.g cancer cells).
This clinical trial is the first study to explore the use of the autoinjector device called the YpsoMate 2.25 mL AI to deliver a cancer treatment (Nivo SC AI, as the investigational study treatment) to patients with cancer. The Nivo SC AI is a single use autoinjector that allows for self-injection of the study treatment.
Nivo IV will be given for up to 52 weeks (1 year) in the absence of disease recurrence, based on disease assessments or if participants are having side effects that make them unable to tolerate their assigned study medication. The number of visits to the study center will depend on the group participants are assigned to (Part 1 Arm A, Part 1 Arm B or Part 2), as well as how long their participation lasts. There is a Screening Period, the Treatment Period, and 2 Follow-up Visits. After that, participants will go to the clinic or the study staff will call them on the phone to assess how the participant is doing every 3 months until participation in the study ends.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0303
Date of REC Opinion
29 Jun 2022
REC opinion
Further Information Favourable Opinion