CA209-8KX: subcutaneous nivolumab monotherapy in multiple tumor types
Research type
Research Study
Full title
Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy
IRAS ID
258172
Contact name
Robert Hugh Jones
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-001585-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 7 months, 6 days
Research summary
This is an early phase trial in patients with advanced cancer subtypes within the lung, kidneys, skin, liver, colon or rectum.
This study will use a drug called Nivolumab which is known to have anticancer activity in these cancers. This study will investigate a different route of administration: delivery of nivolumab under the skin (also known as subcutaneous administration) works as well as how it is normally delivered through the vein. This study will identify the dose required (with or without a protein (called ENHANZE® Drug Product) that assists delivery of drug under the skin). It will also assess safety.
The study is divided into the following periods: Screening, Treatment (consisting of Parts A, B, C and D) and a safety follow-up period.
All patients in Parts A and B will be given a single dose of nivolumab under the skin at the first visit. For visits after the first dose, patients will be given nivolumab through the vein. Once the dose of the nivolumab given under the skin has been identified based on safety data collected from Parts A and B, patients will switch to Part C. Part C will involve patients being treated with the identified dose of nivolumab plus the protein ENHANZE. Part D will be open to patients who have not yet participated in the study.
Patients will continue until completion of the study (104 weeks of treatment) unless one of the following occurs: their disease progresses, they experience unacceptable side effects, they choose to withdraw or the study is stopped.
Patients will have to attend follow up visits at the hospital at 30 and 100 days after the last dose. After completion of the first two follow-up visits, patients on the trial will be followed by telephone every 3 months for up to 5 years.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0232
Date of REC Opinion
22 Aug 2019
REC opinion
Further Information Favourable Opinion