Trial results for the METIMMOX study (NCT03388190) investigating nivolumab in combination with FLOX for metastatic colorectal cancer were posted on ClinicalTrials.gov on 2026-02-13. The study showed a median duration of response of 15.0 months in the experimental arm compared to 9.0 months in the control arm, while progression-free survival was identical at 9.2 months for both arms.
Background
The METIMMOX study aimed to evaluate the efficacy, safety, and tolerability of sequentially adding immune-modulating therapy to standard-of-care therapy for microsatellite-stable (MSS)/mismatch repair-proficient (pMMR) metastatic colorectal cancer (mCRC).
Trial design
The METIMMOX study (NCT03388190) was a Phase 2, completed trial that enrolled 80 participants with metastatic colorectal cancer. The study investigated the sequential addition of nivolumab to FLOX (standard-of-care therapy). The primary outcome measured was Progression-free Survival (PFS).
Key results
Key results from the trial included:
- Progression-free Survival (PFS): The median PFS was 9.2 months for both the control arm and the experimental arm.
- Duration of Response (DOR): The median DOR was 9.0 months for the control arm and 15.0 months for the experimental arm.
- Objective Response Rate (ORR): 20 participants in the control arm achieved an objective response, compared to 17 participants in the experimental arm.
- Incidence of Treatment-related Adverse Events: For specific adverse event categories, the control arm reported 0, 26, and 10 participants, while the experimental arm reported 2, 37, and 11 participants, respectively.
What this means
The results indicate that while the addition of nivolumab to FLOX did not extend progression-free survival in this Phase 2 study for metastatic colorectal cancer, it was associated with a longer median duration of response. The safety data suggests a higher incidence of treatment-related adverse events in the experimental arm compared to the control arm.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03388190, titled "METIMMOX: Colorectal Cancer METastasis - Shaping Anti-tumor IMMunity by OXaliplatin," were posted on 2026-02-13 on clinicaltrials.gov.