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Adding a PD-L1 antibody to an EGFR antibody given a second time helped most in patients whose blood showed no resistance mutations, a seven-month difference in survival between the two groups.
CAVE enrolled 77 patients with pretreated RAS wild-type metastatic colorectal cancer, 71 of them microsatellite-stable, and gave cetuximab rechallenge with avelumab. The trial met its primary endpoint with a median overall survival of 11.6 months (95% CI 8.4 to 14.8) and median progression-free survival of 3.6 months. Baseline circulating tumour DNA for KRAS, NRAS, BRAF and EGFR S492R was analysable in 67 of 77 (87 percent); 48 patients were wild-type in plasma and 19 mutated. Median overall survival was 17.3 months in the plasma wild-type group against 10.4 months in the mutated group (hazard ratio 0.49, 95% CI 0.27 to 0.90, p=0.02), and progression-free survival 4.1 against 3.0 months (hazard ratio 0.42, 0.23 to 0.75, p=0.004). Grade 3 cutaneous eruption affected 14 percent. A later pooled analysis of 180 patients found that the absence of liver metastases and a longer anti-EGFR-free interval mark out who benefits. Like CHRONOS, CAVE is single-arm: it establishes that plasma RAS status selects for rechallenge benefit, not that rechallenge beats standard later-line treatment.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
77 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Cetuximab rechallenge plus avelumab | 77 | 11.6 months | - | - | link |
| Overall survival by baseline plasma RAS and BRAF status | Plasma wild-type | 48 | 17.3 months | 0.49 (0.27 to 0.9) | 0.02 | link |
| Plasma mutated | 19 | 10.4 months |
Shares Cetuximab, Circulating tumour DNA (ctDNA), EGFR, Liquid biopsy (ctDNA).
Shares Cetuximab, EGFR, Liquid biopsy (ctDNA), Colorectal cancer.
Shares Cetuximab, Monoclonal antibodies, Immune checkpoint inhibitors, Colorectal cancer.
Shares Cetuximab, EGFR, Monoclonal antibodies, Colorectal cancer.
Shares Cetuximab, Monoclonal antibodies, Colorectal cancer.
Shares Cetuximab, Monoclonal antibodies, Colorectal cancer.
Shares Cetuximab, EGFR, Monoclonal antibodies, Colorectal cancer.
Shares Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Circulating tumour DNA (ctDNA), Immune checkpoint inhibitors, Colorectal cancer.