Clinical trial NCT03026140: Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
Official title: Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)
Conditions: Colon Carcinoma
Summary: In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.
Interventions:
description: Nivolumab 3mg/kg (day 1 and day 15), administered neoadjuvant before surgery
name: Nivolumab
other_name: nivolumab (opdivo)
type: Drug
description: Ipilimumab 1 mg/kg (day 1) ,administered neoadjuvant before surgery
name: Ipilimumab
other_name: Ipilimumab (Yervoy)
type: Drug
description: celecoxib will be administered starting day 1 until 1 day before surgery daily (if patient is randomized to group 2 (only applicable for patients with a MSS tumor)
name: Celecoxib 200mg
other_name: Celebrex
type: Drug
description: BMS-986253 2400mg IV will be administered on day 1 and 15 (only applicable for patients with MSS tumors)
name: BMS-986253
other_name: Anti-IL8
type: Drug
description: Relatlimab will be administered IV, in cohort 5 240mg on day 1 and day 15, in cohort 6 480mg on day 1 and day 29, in cohort 7 160mg on day 1, day 29 and day 57
name: BMS-986016
other_name: Relatlimab
type: Drug
Study arms:
design_group_description: drug: ipilimumab 1 mg/kg day 1 (IV) drug: nivolumab 3 mg/kg on day 1 and day 15 (IV)
design_group_title: group 1 - closed
design_group_type: Experimental
design_group_description: drug: ipilimumab 1 mg/kg day 1 (IV) drug: nivolumab 3 mg/kg on day 1 and day 15 (IV) drug: celecoxib 200 mg daily (oral)
design_group_title: group 2 - closed
design_group_type: Experimental
design_group_description: drug: nivolumab 3 mg/kg day 1 and day 15 (IV) drug: BMS-986253 (anti-IL8) 2400mg on day 1 and day 15 (IV)
design_group_title: Anti-IL8 cohort 4 (pMMR/MSS tumors) - closed
design_group_type: Experimental
design_group_description: drug: nivolumab 240mg IV on day 1 and day 15 drug: relatlimab 240mg IV on day 1 and day 15
design_group_title: Relatlimab cohort 5 (pMMR/MSS tumors)
design_group_type: Experimental
design_group_description: drug: nivolumab 480mg IV on day 1 and day 29 drug: relatlimab 480mg IV on day 1 and day 29
design_group_title: Relatlimab cohort 6 (dMMR/MSI tumors) - closed
design_group_type: Experimental
design_group_description: Patients with dMMR tumors will be treated with 3 cycles of neoadjuvant nivolumab (480mg) + relatlimab (160mg) on day 1, day 29 and day 57 followed by surgery within 12 weeks and not earlier than 10 weeks from enrollment
design_group_title: Cohort 7 - dMMR - 3 cycles neoadjuvant nivolumab + relatlimab
design_group_type: Experimental
design_group_description: Patients with dMMR tumors will be treated with 3 cycles of neoadjuvant nivolumab (480mg) on day 1, day 29 and day 57 followed by surgery within 12 weeks and not earlier than 10 weeks from enrollment.
design_group_title: Cohort 8 - dMMR - 3 cycles neoadjuvant nivolumab - closed
design_group_type: Experimental
Sponsor: Netherlands Cancer Insitute
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: Adakitug
lang: EN
name: 瑞拉利单抗
lang: CN
name: Relatlimab
lang: EN
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP