BRAF wild-type + NRAS wild-type

P3, N=7, Terminated, Institut de Recherches Internationales Servier | N=500 --> 7 | Trial completion date: Oct 2026 --> Jun 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2026 --> Jun 2023; Decision based on strategic reasons related to limited development options left in metastatic colorectal cancer.

Main eligibility criteria include KRAS/NRAS (exons 2, 3 and 4) and BRAF wt (V600E mutation) (double negative; DN) assessed by centralized analysis of ctDNA at screening, and previous treatment with at least 2 regimens including fluoropyrimidine, irinotecan, oxaliplatin, at least one anti-VEGF (bevacizumab, aflibercept, ramucirumab, regorafenib) and at least one anti-EGFR mAb (cetuximab or panitumumab) for ≥4 months. The key secondary endpoint is OS in the triple-negative (KRAS/NRAS, BRAF, and EGFR-ECD wt) population (part 2). A group sequential design with 3 interim analyses (IA) will allow to stop the trial prematurely for futility at each IA as well as for efficacy at last IA.

P3, N=500, Recruiting, Institut de Recherches Internationales Servier | Not yet recruiting --> Recruiting

Personalized ctDNA analysis with RaDaR may improve risk of death stratification and selection of pts who could benefit from adjuvant treatment. Detection of ctDNA may precede rPD. Follow-up will continue in pts with rising ctDNA who have not yet had rPD.

P2, N=30, Not yet recruiting, Shanghai Zhongshan Hospital

P1b/2a, N=53, Completed, Green Cross Corporation | Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jan 2022

P3, N=500, Not yet recruiting, Institut de Recherches Internationales Servier