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
0 years, 6 months, 10 days
Research summary
Study CA209-8KX is a multicenter, randomized, open-label, phase 1/2 study evaluating the pharmacokinetics (primary objective) and safety profile of nivolumab (secondary objective) administered subcutaneously with or without recombinant human hyaluronidase PH20 (rHuPH20) in participants with one of the following advanced or metastatic tumour types: NSCLC, RCC, melanoma, HCC and MSI-H/dMMR CRC. In Part B, other tumour types may also be considered. rHuPH20 enhances permeation of subcutaneously administered fluid, allowing for improved administration times.
The study is divided into the following periods: Screening, Treatment consisting of Parts A, B, C and D and a safety follow-up period.
Part A is only open for enrolment in US. Parts B, C and D are open in the UK and other countries. After all participants in Parts A and B have been dosed with a single SC Nivolumab dose, they will switch to IV nivolumab until the dose of the SC nivolumab has been assessed based on PK and safety data collected from Parts A and B. Once done, Part A and B participants will switch to Part C with the assessed dose of nivolumab and rHuPH20. Part D will be open to patients who have not participated in any of the previous groups.
The patients will continue until disease progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment or study termination. For each participant who is unable to complete the planned Cycle 1 (SC study treatment) and/or Cycle 2 (IV nivolumab) treatments and PK sampling in Parts A or B, an additional participant will be randomized to study treatment.
The Clinical Follow-up visits will occur 30 and 100 days after the last dose of the study drug. After completion of the first two follow-up visits, subjects will be followed every 3 months for survival for up to 5 years.
REC name
Wales REC 2
REC reference
19/WA/0024
Date of REC Opinion
21 Feb 2019
REC opinion
Unfavourable Opinion