ARRAY-162-202 Phase 1b/2 in patients with Metastatic Colorectal Cancer
Research type
Research Study
Full title
An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination with Nivolumab or Nivolumab Plus Ipilimumab in Patients with Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer with RAS Mutation
IRAS ID
235154
Contact name
Mark Middleton
Contact email
Sponsor organisation
Array BioPharma Inc.
Eudract number
2017-003464-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 27 days
Research summary
Research Summary
This is a multicenter, open-label Phase 1b/2 study to determine the maximum tolerated dose and recommended Phase 2 dose and schedule of binimetinib, and to assess the safety, efficacy and pharmacokinetic(s) of binimetinib administered in combination with nivolumab or nivolumab plus ipilimumab in patients with previously treated microsatellite stable metastatic colorectal cancer who has a mutated gene called RAS. The study will include a dose-finding period in Phase 1b followed by a randomised Phase 2 period.
Phase 1: Arm 1A:
Nivolumab every 4 weeks as a 30 minute infusion and binimetinib. If dose level of binimetinib has unacceptable side effects, then lower dose levels of binimetinib may be tested.Arm 1B
Binimetinib in the recommend dose identified from Arm 1A ; with nivolumab every 4 weeks as a 30 minute IV infusion, and ipilimumab every 8 weeks in a 30 minute IV infusion. Other lower doses of binimetinib may be used.After the main purpose of 1B is reached,Phase 2 begins and patients will be randomly (like flipping a coin) assigned to either arm 2A or 2B.
Phase 2:Arm 2A
Nivolumab every 4 weeks as a 30-minute IV infusion on Day 1 of each treatment cycle and the recommended dose of binimetinib in Arm 1A of Phase 1.Arm 2B
Nivolumab every 4 weeks as a 30-minute IV infusion on Day 1 of each treatment cycle, ipilimumab in a 30-minute IV infusion every 8 weeks and the recommended dose of binimetinib in Arm 1B of Phase 1.Study procedures include medical history, physical examination, vital signs, blood and urine sample collection, CT or MRI scans, ECG and cardiac review.
Array BioPharma Inc. is sponsoring this trial and it is expected that approximately 90 patients will take part from ?? sites worldwide. The study is expected to last 2 years.
Summary of Results
: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVtiUO83io7x4WP0JR0wpUEUa9LVIjzct2HBfE00rQsxW5neFFW1bQaPSm58PYp3GRVzcZNqJx99p6mVnI4xDgUX-2B5etu5u-2Bunf6XVYi-2BQSKbNPAti5hbEegsSxtjyI0yliyZUQd1NVaGSCciaxpAPdBmiLJZ0q7YZZfwC3b5-2BTSaK8G_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLN2aZsW-2FXk2r2TaHeS4-2BjrMIaVaVV9EBEQjeuIZs3-2FMM70LozpiLwMHmHJwQALDYqj1Y5MDGA1AG1FeNey9aCqHuFS7BfmdyI9sRICfTPxeEtG1P-2Fe4gN3rUd9eFWAoeXDfYO-2BeFjWkxjUHq3jJEw5WvgnSk47AD3o9ypil4ubiw-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Cd62bc4330641491449e708da1c71529d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637853570282762962%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=z5F4aZ1FhEY9eI7u%2FA6eHBaSOX4iFPJfqFOh9wosGss%3D&reserved=0
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0439
Date of REC Opinion
8 Jan 2018
REC opinion
Further Information Favourable Opinion