TAK-659 in Combination With Nivolumab in Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1b Study to Evaluate TAK-659 in Combination With Nivolumab in Patients With Advanced Solid Tumors
IRAS ID
216108
Contact name
Alastair Greystoke
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
Eudract number
2016-000853-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 26 days
Research summary
This is a phase 1b study is to investigate a new medicine called TAK-659 (“the Takeda Study Medication”) used in combination with nivolumab as a possible treatment for patients with cancer (advanced solid tumours).
The use of TAK-659 is experimental meaning it has not been yet approved by regulatory authorities. Nivolumab has been approved by regulatory authorities to treat advanced melanoma (an aggressive form of skin cancer), advanced non-small cell lung cancer and advanced kidney cancer. Individuals enrolled in this study will be the first participants to receive TAK-659 in combination with nivolumab.
The study will include a dose escalation phase (Part 1) and a dose expansion phase (Part 2).
The study will enroll approximately 120 participants, approximately 9-12 in the dose escalation phase and approximately 36 in each of the 3 dose expansion cohorts. Participants will be assigned to 1 of the 4 treatment groups:
· Part 1: Advanced Solid Tumours
· Part 2: Metastatic triple-negative breast cancer
· Part 2: Metastatic non-small cell lung cancer
· Part 2: Metastatic head and neck squamous cell carcinomaAll participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study. Participants will also receive intravenous infusion of nivolumab (within 30 minutes after the TAK-650 dose) once every 2 weeks.
Approximately 25 study centres in North America and Europe will take part in this study. Participants may receive study medicine for up to 12 months (unless their doctor believes they would benefit from continued treatment longer than 12 months), and up to an additional 12 months for follow up.
Participants will undergo procedures including medical history, physical exam, height, weight, blood pressure, temperature, heart rate, rate of breathing, ECG (recording of the heart), blood tests, urine test, eye tests, tumour biopsies, CT scan, MRI.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0137
Date of REC Opinion
12 May 2017
REC opinion
Further Information Favourable Opinion