Nivolumab Trial in MSI-H Colorectal Cancer Reports PFS Data

A Phase 3 study of nivolumab in metastatic colorectal cancer reached primary completion on 28 August 2024, according to ClinicalTrials.gov. The trial enrolled 839 participants with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) disease and reported progression-free survival (PFS) measurements and hazard-ratio analyses.

Background

The study evaluated nivolumab alone, nivolumab combined with ipilimumab, and investigator’s choice chemotherapy in participants with MSI-H or dMMR metastatic colorectal cancer. The registry’s listed chemotherapy interventions included oxaliplatin, leucovorin, fluorouracil, and irinotecan. Its stated aims were to compare clinical benefit using PFS, objective response rate, and overall survival, including comparisons between the nivolumab combination and chemotherapy.

Trial design

This was a Phase 3 study in metastatic colorectal cancer. The registry identified three treatment groups: Arm A, nivolumab monotherapy; Arm B, nivolumab plus ipilimumab; and Arm C, investigator’s choice chemotherapy. The study status was active, not recruiting at the time represented in the data. PFS was assessed by blinded independent review, with analyses covering all randomized participants, first-line participants, and centrally confirmed MSI-H/dMMR groups.

Key results

Among all randomized participants, median PFS was 18.43 months with nivolumab monotherapy and 54.08 months with nivolumab plus ipilimumab. In first-line randomized participants, median PFS was 44.85 months with nivolumab monotherapy and 6.21 months with investigator’s choice chemotherapy. Several other median estimates were listed as NA, indicating that a median was not available in the supplied record.

The registry also reported hazard-ratio analyses. Two log-rank analyses listed hazard ratios of 0.62, with a 95% confidence interval of 0.48 to 0.81 and p=0.0003, and 0.21, with a 95% confidence interval of 0.14 to 0.32 and p=0.0001. Additional reported hazard ratios were 0.64 (95% confidence interval, 0.52 to 0.79), 0.32 (0.23 to 0.46), 0.60 (0.45 to 0.80), and 0.63 (0.48 to 0.83). The supplied data do not identify the comparison attached to each additional analysis.

What this means

The registry record provides PFS results from a three-arm Phase 3 evaluation of nivolumab-based treatment in MSI-H or dMMR metastatic colorectal cancer. The reported medians and hazard ratios describe longer PFS for some nivolumab comparisons, but the supplied data do not provide outcome labels for every hazard-ratio analysis. No adverse-event summary was included, and the record alone does not establish a new regulatory approval.

Source

Source: ClinicalTrials.gov, trial record for NCT04008030, with the primary-completion event dated 28 August 2024. The registry record is available at clinicaltrials.gov/study/NCT04008030.