# CheckMate 9DW

Source: https://onco.cc/trials/checkmate-9dw/  
OnCo record `checkmate-9dw` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Dual immune checkpoint blockade gave the longest median survival yet seen in a first-line liver cancer trial.

## Summary

CheckMate 9DW, trial NCT04039607 sponsored by Bristol Myers Squibb and reported in 2024, showed that dual checkpoint blockade with nivolumab plus ipilimumab gives the longest median survival yet seen in a first-line liver cancer trial. It randomised 668 patients with unresectable hepatocellular carcinoma to the combination or to lenvatinib or sorafenib, met its primary overall survival endpoint, and produced a much higher response rate with far more durable responses, leading to FDA approval in April 2025, at the cost of more immune-related toxicity than single-agent regimens. OnCo links it to PD-1 and CTLA-4 as targets and to nivolumab and ipilimumab. Whether the extra toxicity is worth it for all patients, or whether a biomarker could pick those who need the CTLA-4 component, is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04039607
- Phase: 3
- Setting: First-line unresectable HCC: nivolumab + ipilimumab vs lenvatinib or sorafenib
- Sponsor: BMS
- Enrolled: 732
- Result: OS 23.7 vs 20.6 months, HR 0.79; ORR 36% vs 13%.
- Outcomes: Overall survival: Nivolumab + ipilimumab 23.7 months vs Lenvatinib or sorafenib 20.6 months, HR 0.79; Objective response rate: Nivolumab + ipilimumab 36% vs Lenvatinib or sorafenib 13%

## Sources

- ClinicalTrials.gov NCT04039607: https://clinicaltrials.gov/study/NCT04039607
- Lancet 2025: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00403-9/fulltext

## Connected records

- cancers: [Advanced hepatocellular carcinoma (BCLC C)](https://onco.cc/cancers/hcc-advanced/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- ideas: [Immunotherapy downstaging to transplant with a safe washout](https://onco.cc/ideas/idea-hcc-io-before-transplant/)

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JSON: https://onco.cc/api/v1/entities/checkmate-9dw.json