At a glance
ClinicalIndex Comparison Record- ✓Histologically verified colorectal adenocarcinoma (including mucinous and signet-ring cell variants)
- ✓ECOG performance status 0 or 1
- ✓Radiologically measurable metastatic disease
- ✓Intra-abdominal metastatic lesion amenable to biopsy
- ✕Initially resectable metastatic disease where neoadjuvant therapy is deemed unnecessary
- ✕Lung metastases as sole site of metastatic disease
- ✕Untreated or symptomatic brain metastases (must be symptom-free without corticosteroids)
- ✕Less than 6 months since discontinuation of adjuvant oxaliplatin-containing chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
METIMMOX: Colorectal Cancer METastasis - Shaping Anti-tumor IMMunity by OXaliplatin
In Brief
A Phase 2 clinical trial evaluating Nivolumab and FLOX for Colorectal Cancer Metastatic. Completed, enrolled 80 participants across 5 sites.
Detailed Summary
This study aims to determine the efficacy, safety, and tolerability of the sequential addition of immune-modulating therapy to standard-of-care therapy of microsatellite-stable (MSS)/mismatch repair-proficient (pMMR) metastatic colorectal cancer (mCRC).
Study Details
Timeline
Interventions
FLOX: Intravenous oxaliplatin 85 mg/m2 on day 1; bolus 5-fluorouracil 500 mg/m2 and bolus Leucovorin on days 1 and 2; IV administration every 2 weeks. Nivolumab: 240 mg flat dose; IV administration every 2 weeks.
FLOX: Intravenous oxaliplatin 85 mg/m2 on day 1; bolus 5-fluorouracil 500 mg/m2 and bolus Leucovorin on days 1 and 2; IV administration every 2 weeks.