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    BIOMARKER:

    TMB-H

    i
    Related biomarkers:
    Expression
    Others
    Related tests:
    Apply
    Precision-Based Genomics in Prostate Cancer (NCT04706663)
    Phase N/A
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    09/14/2021
    Primary completion :
    06/30/2026
    Completion :
    06/30/2027
    TMB • RB1 • MLH1 • MSH6 • MSH2 • CDK12 • RAD51 • BRIP1 • RAD50 • SPOP • EPCAM
    |
    TMB-H
    Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations (NCT06043713)
    Phase 1
    Fred Hutchinson Cancer Center
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    12/15/2023
    Primary completion :
    12/31/2025
    Completion :
    02/09/2026
    HER-2 • KRAS • BRAF • ALK • TMB • MSI • NTRK
    |
    KRAS mutation • TMB-H • BRAF mutation • HER-2 amplification • ROS1 fusion • KRAS G12 • NTRK fusion
    |
    cyclophosphamide • bendamustine • fludarabine IV
    A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (NCT05904496)
    Phase 1
    BeiGene
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    07/19/2023
    Primary completion :
    12/01/2026
    Completion :
    12/01/2026
    TMB • MSI
    |
    TMB-H • MSI-H/dMMR
    |
    Tevimbra (tislelizumab-jsgr) • BGB-30813
    Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma (NCT02359565)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/03/2025
    Initiation :
    06/03/2015
    Primary completion :
    12/21/2025
    Completion :
    12/21/2025
    PD-L1 • TMB
    |
    TMB-H
    |
    Keytruda (pembrolizumab) • Pembroria (pembrolizumab biosimilar)
    A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants with Advanced Solid Tumors (START-001) (NCT05592626)
    Phase 1/2
    Marengo Therapeutics, Inc.
    Recruiting
    Last update posted :
    01/30/2025
    Initiation :
    01/04/2023
    Primary completion :
    10/01/2026
    Completion :
    10/01/2026
    KRAS • TMB • MSI • RAS
    |
    KRAS mutation • TMB-H • MSI-H/dMMR • RAS mutation • RAS wild-type
    |
    invikafusp alfa (STAR0602)
    A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H) (IMperator) (NCT06331598)
    Phase 2
    Hoffmann-La Roche
    Withdrawn
    Last update posted :
    12/24/2024
    Initiation :
    11/30/2024
    Primary completion :
    10/20/2028
    Completion :
    09/20/2029
    TMB • MSI
    |
    TMB-H • MSI-H/dMMR
    |
    Tecentriq (atezolizumab) • tiragolumab (RG6058)
    Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 (KEYNOTE-E64) (NCT04787042)
    Phase 1/2
    Simcha IL-18, Inc.
    Recruiting
    Last update posted :
    11/15/2024
    Initiation :
    08/06/2021
    Primary completion :
    06/30/2025
    Completion :
    12/31/2025
    ALK • TMB • MSI
    |
    TMB-H • MSI-H/dMMR • ALK positive • ALK mutation
    |
    Keytruda (pembrolizumab) • Gazyva (obinutuzumab) • vevoctadekin (ST-067)
    Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (KEYNOTE A99) (NCT04198766)
    Phase 1/2
    Inhibrx Biosciences, Inc
    Recruiting
    Last update posted :
    07/19/2024
    Initiation :
    12/10/2019
    Primary completion :
    02/02/2026
    Completion :
    05/15/2026
    EGFR • PD-L1 • ALK • TMB
    |
    EGFR mutation • TMB-H • MSI-H/dMMR • ALK rearrangement
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • INBRX-106
    Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (PNeoVCA) (NCT05269381)
    Phase 1/2
    Mayo Clinic
    Recruiting
    Last update posted :
    06/12/2024
    Initiation :
    03/31/2022
    Primary completion :
    02/24/2025
    Completion :
    02/24/2026
    KRAS • BRAF • ALK • TMB • MSI • ROS1 • NTRK
    |
    TMB-H
    |
    Keytruda (pembrolizumab) • cyclophosphamide • Leukine (sargramostim) • neoantigen peptide vaccine
    Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (NCT03493945)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    05/01/2018
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    TMB • BRCA1 • BRCA2 • MSI • HRD
    |
    TMB-H • MSI-H/dMMR
    |
    bintrafusp alfa (M7824) • epacadostat (INCB024360) • Anktiva (nogapendekin alfa inbakicept-pmln)
    Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors (NCT04087018)
    Phase 1
    Arcus Biosciences, Inc.
    Active, not recruiting
    Last update posted :
    05/24/2024
    Initiation :
    09/24/2019
    Primary completion :
    09/01/2024
    Completion :
    09/01/2024
    TMB
    |
    TMB-H
    |
    Yutuo (zimberelimab)
    A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) (NCT02332668)
    Phase 1/2
    Merck Sharp & Dohme LLC
    Recruiting
    Last update posted :
    05/22/2024
    Initiation :
    03/18/2015
    Primary completion :
    10/25/2027
    Completion :
    10/25/2027
    PD-L1 • MSI
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR
    |
    Keytruda (pembrolizumab)
    Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer (NCT05093231)
    Phase 2
    Cambridge University Hospitals NHS Foundation T...
    Not yet recruiting
    Last update posted :
    05/20/2024
    Initiation :
    06/17/2024
    Primary completion :
    12/31/2025
    Completion :
    05/04/2026
    TMB • MSI
    |
    TMB-H • MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    Study of NEO-201 in Solid Tumors Expansion Cohorts (QUILT-3.017) (NCT03476681)
    Phase 1/2
    Precision Biologics, Inc
    Recruiting
    Last update posted :
    05/15/2024
    Initiation :
    01/18/2019
    Primary completion :
    10/15/2025
    Completion :
    10/15/2026
    EGFR • PD-L1 • BRAF • TMB • MSI • ROS1 • ALK1
    |
    PD-L1 expression • BRAF V600E • TMB-H • MSI-H/dMMR • BRAF V600
    |
    Keytruda (pembrolizumab) • NEO-201
    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158) (NCT02628067)
    Phase 2
    Merck Sharp & Dohme LLC
    Recruiting
    Last update posted :
    05/10/2024
    Initiation :
    12/18/2015
    Primary completion :
    05/04/2027
    Completion :
    05/04/2027
    TMB • MSI
    |
    TMB-H • MSI-H/dMMR
    |
    Keytruda (pembrolizumab)
    A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial (NCT06069726)
    Phase 2
    Duke University
    Recruiting
    Last update posted :
    04/17/2024
    Initiation :
    03/21/2024
    Primary completion :
    01/01/2026
    Completion :
    01/01/2027
    TMB • CD4
    |
    TMB-H • IDH wild-type
    |
    Tecentriq (atezolizumab)
    Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer (INSPIRE) (NCT04717154)
    Phase 2
    Radboud University Medical Center
    Active, not recruiting
    Last update posted :
    04/16/2024
    Initiation :
    01/19/2021
    Primary completion :
    08/15/2024
    Completion :
    02/15/2026
    TMB • BRCA2 • CDK12
    |
    TMB-H
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors (NCT04891198)
    Phase 2
    3D Medicines (Sichuan) Co., Ltd.
    Recruiting
    Last update posted :
    04/03/2024
    Initiation :
    08/06/2021
    Primary completion :
    08/30/2027
    Completion :
    04/30/2028
    TMB
    |
    TMB-H
    |
    Enweida (envafolimab)
    Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen (NCT06036745)
    Phase 2
    Shanghai Minimally Invasive Surgery Center
    Recruiting
    Last update posted :
    03/07/2024
    Initiation :
    07/01/2022
    Primary completion :
    07/01/2023
    Completion :
    07/01/2026
    PD-L1 • TMB • MSI
    |
    TMB-H • MSI-H/dMMR • PD-L1 overexpression
    |
    Keytruda (pembrolizumab) • oxaliplatin
    XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT05005728)
    Phase 2
    Xencor, Inc.
    Recruiting
    Last update posted :
    03/05/2024
    Initiation :
    10/22/2021
    Primary completion :
    03/31/2025
    Completion :
    09/30/2025
    TMB • MSI • HRD
    |
    TMB-H • MSI-H/dMMR
    |
    Lynparza (olaparib) • carboplatin • docetaxel • cabazitaxel • vudalimab (XmAb717)
    Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study (NCT04392505)
    Phase 2
    Oslo University Hospital
    Active, not recruiting
    Last update posted :
    02/29/2024
    Initiation :
    05/11/2020
    Primary completion :
    05/01/2025
    Completion :
    05/01/2033
    PD-L1 • TMB
    |
    TMB-H • TMB-L
    |
    Imfinzi (durvalumab)
    Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (NCT03809624)
    Phase 2
    Inhibrx, Inc.
    Recruiting
    Last update posted :
    02/21/2024
    Initiation :
    01/30/2019
    Primary completion :
    08/01/2025
    Completion :
    12/01/2025
    TMB
    |
    TMB-H
    |
    Keytruda (pembrolizumab) • enristomig (INBRX-105)
    Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden (NCT03671720)
    Phase 1
    Capital Medical University
    Withdrawn
    Last update posted :
    02/07/2024
    Initiation :
    09/11/2018
    Primary completion :
    12/30/2021
    Completion :
    12/30/2022
    TMB
    |
    TMB-H
    |
    cyclophosphamide
    BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer (NCT03083691)
    Phase 2
    Lung Cancer Group Cologne
    Completed
    Last update posted :
    01/17/2024
    Initiation :
    04/13/2017
    Primary completion :
    08/31/2022
    Completion :
    11/20/2023
    TMB
    |
    TMB-H
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition (NCT05770102)
    Phase 2/3
    Cancer Research UK
    Recruiting
    Last update posted :
    01/05/2024
    Initiation :
    10/25/2023
    Primary completion :
    10/01/2029
    Completion :
    10/01/2029
    TMB
    |
    TMB-H • MSI-H/dMMR
    |
    Tecentriq (atezolizumab)
    PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer (PCOX) (NCT03638297)
    Phase 2
    Sun Yat-sen University
    Recruiting
    Last update posted :
    10/17/2023
    Initiation :
    08/23/2018
    Primary completion :
    08/20/2022
    Completion :
    08/31/2025
    TMB • MSI
    |
    TMB-H • MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • BAT1306
    A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) (CheckMate 848) (NCT03668119)
    Phase 2
    Bristol-Myers Squibb
    Completed
    Last update posted :
    09/01/2023
    Initiation :
    10/31/2018
    Primary completion :
    05/03/2022
    Completion :
    08/02/2023
    TMB
    |
    TMB-H
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) (NCT05332561)
    Phase 2
    German Cancer Research Center
    Recruiting
    Last update posted :
    07/06/2023
    Initiation :
    06/29/2023
    Primary completion :
    03/01/2030
    Completion :
    12/01/2030
    HER-2 • PD-L1 • PIK3CA • TMB • BRCA1 • BRCA2 • PARP1 • TACSTD2
    |
    HER-2 positive • TMB-H • HR positive • MSI-H/dMMR • HER-2 negative • PIK3CA mutation • HER-2 exon 20 insertion • PALB2 mutation • HR positive + HER-2 negative • HER-2 exon 20 mutation
    |
    Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Perjeta (pertuzumab) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment. (NCT03156114)
    Phase 1
    Boehringer Ingelheim
    Completed
    Last update posted :
    06/29/2023
    Initiation :
    06/13/2017
    Primary completion :
    03/09/2023
    Completion :
    06/06/2023
    EGFR • ALK • TMB • MSI
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers (CHECKMATE 817) (NCT02869789)
    Phase 3b/4
    Bristol-Myers Squibb
    Completed
    Last update posted :
    06/14/2023
    Initiation :
    10/05/2016
    Primary completion :
    05/13/2022
    Completion :
    05/13/2022
    PD-L1 • TMB
    |
    TMB-H
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    Phase Ib of L-NMMA and Pembrolizumab (NCT03236935)
    Phase 1
    The Methodist Hospital Research Institute
    Active, not recruiting
    Last update posted :
    05/04/2023
    Initiation :
    08/03/2018
    Primary completion :
    10/31/2021
    Completion :
    12/28/2023
    PD-L1 • BRAF • TMB • MSI
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • BRAF mutation
    |
    Keytruda (pembrolizumab) • tilarginine (L-NMMA)
    Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (CheckMate 568) (NCT02659059)
    Phase 2
    Bristol-Myers Squibb
    Completed
    Last update posted :
    04/05/2023
    Initiation :
    02/15/2016
    Primary completion :
    06/22/2018
    Completion :
    03/07/2022
    PD-L1 • TMB
    |
    PD-L1 expression • TMB-H • PD-L1 negative • TMB-L
    |
    Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
    An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate 498) (NCT02617589)
    Phase 3
    Bristol-Myers Squibb
    Completed
    Last update posted :
    03/28/2023
    Initiation :
    03/01/2016
    Primary completion :
    01/17/2019
    Completion :
    03/04/2022
    TMB • MGMT
    |
    TMB-H
    |
    Opdivo (nivolumab) • temozolomide
    A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE) (NCT03475953)
    Phase 1/2
    Institut Bergonié
    Recruiting
    Last update posted :
    03/03/2023
    Initiation :
    05/04/2018
    Primary completion :
    12/31/2024
    Completion :
    12/31/2025
    PD-L1 • BRAF • ALK • TMB • MSI • ROS1 • CTLA4
    |
    TMB-H • ALK positive • ALK mutation • ROS1 positive
    |
    Bavencio (avelumab) • Stivarga (regorafenib)
    Evaluation of Blood TMB for the Efficacy of Atezolizumab [BUDDY] (NCT04059887)
    Phase 4
    Chonnam National University Hospital
    Completed
    Last update posted :
    02/08/2023
    Initiation :
    12/18/2019
    Primary completion :
    12/31/2021
    Completion :
    06/30/2022
    EGFR • ALK • TMB • PD-1
    |
    TMB-H
    |
    Tecentriq (atezolizumab)
    Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (YBL006C101) (NCT04450901)
    Phase 1/2
    Y Biologics Inc.
    Active, not recruiting
    Last update posted :
    12/05/2022
    Initiation :
    07/01/2020
    Primary completion :
    03/31/2023
    Completion :
    03/31/2023
    EGFR • PD-L1 • ALK • TMB • MSI
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • ALK translocation
    |
    acrixolimab (YBL-006)
    Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma (NCT02968940)
    Phase 2
    NYU Langone Health
    Completed
    Last update posted :
    06/29/2022
    Initiation :
    03/17/2017
    Primary completion :
    08/29/2019
    Completion :
    08/29/2019
    TMB • MSI • IDH1 • IDH2 • POLE • MLH1 • MSH6 • POLD1
    |
    TMB-H • IDH2 mutation
    |
    Bavencio (avelumab)
    IBI308 in Subjects With Advanced/Metastatic Solid Malignancies (NCT03568539)
    Phase 1b
    Innovent Biologics (Suzhou) Co. Ltd.
    Completed
    Last update posted :
    06/01/2021
    Initiation :
    06/27/2018
    Primary completion :
    11/09/2020
    Completion :
    12/07/2020
    ALK • TMB • ROS1
    |
    EGFR mutation • TMB-H • ALK rearrangement • ROS1 positive
    |
    Tyvyt (sintilimab)
    A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers (NCT04603040)
    Phase 2
    Shanghai Junshi Bioscience Co., Ltd.
    Recruiting
    Last update posted :
    10/26/2020
    Initiation :
    09/28/2020
    Primary completion :
    12/31/2022
    Completion :
    03/31/2023
    PD-L1 • TMB • MSI
    |
    PD-L1 expression • HER-2 positive • TMB-H • MSI-H/dMMR
    |
    Loqtorzi (toripalimab-tpzi)