ArticleESMO gastrointestinal oncology2026
Predictive biomarkers for cetuximab-based rechallenge therapy in metastatic colorectal cancer: a pooled analysis of the CAVE and CAVE-2 GOIM studies.
Article in ESMO gastrointestinal oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CAVE (Cetuximab-AVElumab) mCRC: A Single Arm Phase II Clinical Study of the Combination of Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer Patients
CAVE-2 (Cetuximab-AVElumab) mCRC: A Phase II Randomized Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy in Pre-treated RAS/BRAF Wild Type Metastatic Colorectal Cancer Patients.
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Abstract
Background: Anti-epidermal growth factor receptor (EGFR) therapy is a therapeutic option in patients with molecularly selected metastatic colorectal cancer (mCRC). However, the identification of predictive factors represents an unmet need. Patients and methods: We conducted a pooled analysis of individual patient data from the CAVE-GOIM (NCT04561336) and CAVE-2 GOIM (NCT05291156) studies to investigate the impact of several clinical variables on rechallenge with cetuximab with and without avelumab in circulating tumor DNA Results: Overall, 180 patients met the eligibility criteria: 136 received cetuximab-avelumab and 44 cetuximab. In patients receiving cetuximab monotherapy, median progression-free survival (mPFS) was 4.80 months [95% confidence interval (CI) 3.90-5.90] and median overall survival (mOS) 12.9 months (95% CI 11.1-not evaluable). Cetuximab activity was retained regardless of clinical factors. Patients treated with cetuximab-avelumab showed an mPFS of 5.00 months (95% CI 4.30-5.90) and mOS of 15.7 months (95% CI 13.0-19.9). In univariable analysis, a shorter progression-free survival was observed in patients with liver involvement [hazard ratio (HR) 2.19, 95% CI 1.51-3.20, Conclusions: Single-agent cetuximab activity is not influenced by clinical factors. In cetuximab-avelumab therapy, the absence of liver metastases and longer anti-EGFR-free interval might represent potential biomarkers.
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