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    BIOMARKER:

    BRAF wild-type + NRAS wild-type

    i
    Other names: BRAF, B-raf proto-oncogene, B-raf proto-oncogene, Serine/threonine kinase, V-Raf murine sarcoma viral oncogene homolog B, Serine/threonine-protein kinase B-Raf, Proto-oncogene B-Raf, BRAF1, RAFB1, B-raf proto-oncogene Serine/threonine-protein kinase, Murine sarcoma viral (V-Raf) oncogene homolog B1, B-raf serine/threonine-protein, 94 KDa B-raf protein, B-RAF1, KRAS, KRAS proto-oncogene GTPase, KRAS1, KRAS2, NS, NS3, OES, CFC2, RALD, K-Ras, RASK2, KI-RAS, C-K-RAS, K-RAS2A, K-RAS2B, K-RAS4A, K-RAS4B, K-Ras 2, C-K-RAS, c-Ki-ras, c-Ki-ras2, Kirsten rat sarcoma viral oncogene homolog
    Entrez ID:
    673; 4893
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    over1year
    COLSTAR: Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov)
    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.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    KRAS wild-type • BRAF wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    Lonsurf (trifluridine/tipiracil) • futuximab/modotuximab (S95026)
    over2years
    COLSTAR: Randomized, open-label, multicentre, phase III study comparing futuximab/modotuximab plus trifluridine/tipiracil to trifluridine/tipiracil in KRAS/NRAS and BRAF wild type (wt) metastatic colorectal cancer (mCRC) previously treated with both standard and anti-EGFR treatment (ESMO 2022)
    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.
    Clinical • P3 data
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
    |
    BRAF V600E • KRAS wild-type • BRAF wild-type • NRAS wild-type • KRAS exon 2 mutation • BRAF V600 wild-type • BRAF wild-type + NRAS wild-type
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • Stivarga (regorafenib) • Cyramza (ramucirumab) • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • futuximab/modotuximab (S95026)
    over2years
    COLSTAR: Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=500, Recruiting, Institut de Recherches Internationales Servier | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    KRAS wild-type • BRAF wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    Lonsurf (trifluridine/tipiracil) • futuximab/modotuximab (S95026)
    over2years
    Leveraging personalized circulating tumor DNA (ctDNA) for detection and monitoring of molecular residual disease in high-risk melanoma. (ASCO 2022)
    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.
    Circulating tumor DNA
    |
    BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    RAS wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    RaDaR™ assay
    over2years
    Pembrolizumab and Disitamab Vedotin in HER2-expressing Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Shanghai Zhongshan Hospital
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    HER-2 expression • KRAS wild-type • BRAF wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    Keytruda (pembrolizumab) • Aidixi (disitamab vedotin)
    almost3years
    A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy (clinicaltrials.gov)
    P1b/2a, N=53, Completed, Green Cross Corporation | Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jan 2022
    Trial completion • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    EGFR expression • KRAS wild-type • BRAF wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    5-fluorouracil • irinotecan • leucovorin calcium • GC-1118A
    almost3years
    COLSTAR: Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Institut de Recherches Internationales Servier
    New P3 trial • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    KRAS wild-type • BRAF wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    Lonsurf (trifluridine/tipiracil) • futuximab/modotuximab (S95026)