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    BIOMARKER:

    TP53 mutation

    i
    Entrez ID:
    7157
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Apply
    Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study (NCT04269902)
    Phase 3
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    03/02/2021
    Primary completion :
    10/01/2028
    Completion :
    10/01/2028
    TP53 • IGH
    |
    TP53 mutation • IGH mutation
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab)
    Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (NCT03041688)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    02/08/2018
    Primary completion :
    06/30/2026
    Completion :
    06/30/2026
    TP53 • CD4
    |
    TP53 mutation • Chr del(17p) • TP53 wild-type
    |
    Venclexta (venetoclax) • azacitidine • decitabine • navtemadlin (KRT-232)
    Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease (NCT06023641)
    Phase 1/2
    St. Jude Children's Research Hospital
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    03/13/2024
    Primary completion :
    10/01/2034
    Completion :
    10/01/2037
    TP53 • FOXO1 • MYOD1
    |
    TP53 mutation
    |
    temozolomide • cyclophosphamide • vincristine • vinorelbine tartrate • dactinomycin • Onivyde (nanoliposomal irinotecan) • Navelbine oral (vinorelbine tartrate oral) • Neupogen (filgrastim)
    A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (SUMIT-BC) (NCT05963984)
    Phase 2
    Carrick Therapeutics Limited
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    12/14/2023
    Primary completion :
    06/30/2025
    Completion :
    12/31/2025
    HER-2 • ER • TP53 • CDK4
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    fulvestrant • samuraciclib (CT7001)
    Clinical and Genetic Studies of Li-Fraumeni Syndrome (NCT01443468)
    Phase N/A
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    01/17/2012
    TP53
    |
    TP53 mutation
    Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer (NCT05941520)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    08/23/2024
    Primary completion :
    08/23/2027
    Completion :
    09/01/2028
    TP53 • PTEN • ATM • NF1 • MSH6 • CDH1 • CHEK2 • BRIP1 • RAD51C • RAD51D • BARD1 • NBN • AGR2
    |
    TP53 mutation • ATM mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • RAD51D mutation • BARD1 mutation
    |
    tamoxifen • acolbifene
    A Study of Samuraciclib and Elacestrant in Participants with Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (SUMIT-ELA) (NCT05963997)
    Phase 1/2
    Carrick Therapeutics Limited
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    10/09/2023
    Primary completion :
    12/23/2025
    Completion :
    12/23/2025
    HER-2 • ER • TP53 • CDK4
    |
    TP53 mutation • ER positive • HER-2 negative • HER-2 negative + ER positive • HER-2 negative + ER positive + ESR1 mutation
    |
    Orserdu (elacestrant) • samuraciclib (CT7001)
    A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (NT-175-201) (NCT05877599)
    Phase 1
    AstraZeneca
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    07/12/2023
    Primary completion :
    09/01/2028
    Completion :
    08/01/2039
    TP53 • HLA-A
    |
    TP53 mutation • HLA-A*02:01
    |
    cyclophosphamide • fludarabine IV • NT-175
    Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) (NCT05554393)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    09/13/2024
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    TP53 • FLT3 • NPM1 • RUNX1 • ASXL1 • RARA • RUNX1T1 • PML • CEBPA
    |
    TP53 mutation • FLT3-ITD mutation • NPM1 mutation • RUNX1 mutation • ASXL1 mutation • FLT3-TKD mutation
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • Starasid (cytarabine ocfosfate)
    Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial (NCT04704661)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    08/09/2021
    Primary completion :
    03/31/2026
    Completion :
    03/31/2026
    HER-2 • TP53 • ATM • RAS • CD4
    |
    HER-2 positive • TP53 mutation • HER-2 amplification • HER-2 expression • RAS mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • ceralasertib (AZD6738)
    P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT03113487)
    Phase 2
    City of Hope Medical Center
    Active, not recruiting
    Last update posted :
    02/19/2025
    Initiation :
    02/01/2018
    Primary completion :
    08/26/2022
    Completion :
    06/03/2025
    PD-L1 • TP53 • MUC16
    |
    TP53 mutation
    |
    Keytruda (pembrolizumab) • p53MVA
    Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS (NCT04708054)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    10/21/2021
    Primary completion :
    12/31/2027
    Completion :
    12/31/2027
    KRAS • NRAS • DNMT3A • NF1 • RUNX1 • ASXL1 • PTPN1
    |
    TP53 mutation • KRAS mutation • NRAS mutation • RAS mutation
    |
    Venclexta (venetoclax) • cladribine • fludarabine IV • thiotepa • busulfan
    Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) (NCT04634877)
    Phase 3
    Merck Sharp & Dohme LLC
    Active, not recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/10/2021
    Primary completion :
    05/31/2026
    Completion :
    05/31/2026
    TP53
    |
    TP53 mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • paclitaxel • docetaxel
    A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden (NCT04145115)
    Phase 2
    National Cancer Institute (NCI)
    Suspended
    Last update posted :
    02/17/2025
    Initiation :
    12/24/2020
    Primary completion :
    05/31/2025
    Completion :
    05/31/2025
    EGFR • TP53 • CDKN2A • TERT • CDKN2B • ATRX
    |
    TP53 mutation • EGFR mutation • EGFR amplification • CDKN2A deletion • IDH wild-type
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ABP 206 (nivolumab biosimilar)
    Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (NCT03772925)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/14/2025
    Initiation :
    06/20/2019
    Primary completion :
    06/16/2025
    Completion :
    06/16/2025
    BCL2 • CD4
    |
    TP53 mutation • FLT3 mutation
    |
    pevonedistat (MLN4924) • Beleodaq (belinostat)
    Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia (NCT06311227)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    05/15/2025
    Primary completion :
    05/20/2027
    Completion :
    05/20/2027
    BRAF • TP53
    |
    TP53 mutation
    |
    Venclexta (venetoclax)
    CLL Therapy Approaches in Russia (CLL registry) (NCT05140369)
    Phase N/A
    AstraZeneca
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    10/29/2021
    Primary completion :
    12/31/2027
    Completion :
    12/31/2027
    TP53 • IGH
    |
    TP53 mutation
    A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). (NCT05947851)
    Phase 3
    Merck Sharp & Dohme LLC
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    08/08/2023
    Primary completion :
    06/27/2033
    Completion :
    06/27/2033
    TP53 • BTK • IGH
    |
    TP53 mutation • IGH mutation
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • nemtabrutinib (MK-1026)
    Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma (Window-2) (NCT03710772)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    02/11/2025
    Initiation :
    05/01/2019
    Primary completion :
    05/22/2025
    Completion :
    05/22/2025
    TP53 • CD20 • NSD2
    |
    TP53 mutation • CD20 positive
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • vincristine • dexamethasone • Truxima (rituximab-abbs) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Novex (rituximab biosimilar) • SIBP-02 (rituximab biosimilar) • Starasid (cytarabine ocfosfate) • cyclophosphamide intravenous • dexamethasone injection • methotrexate IV
    Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects with MDS or AML (SL03-OHD-104) (NCT05275439)
    Phase 1
    Shattuck Labs, Inc.
    Completed
    Last update posted :
    02/11/2025
    Initiation :
    03/17/2022
    Primary completion :
    02/06/2025
    Completion :
    02/06/2025
    TP53
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • azacitidine • SL-172154
    Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT04169737)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    07/29/2020
    Primary completion :
    07/09/2026
    Completion :
    07/09/2026
    TP53 • IGH
    |
    TP53 mutation • Chr del(11q)
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (NCI-2018-01789) (NCT03661307)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    10/31/2018
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    TP53 • FLT3
    |
    TP53 mutation • FLT3-ITD mutation • FLT3 mutation • TP53 deletion
    |
    Venclexta (venetoclax) • azacitidine • Vanflyta (quizartinib) • decitabine
    Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia (NCI-2020-04163) (NCT04435691)
    Phase 1/2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    07/28/2020
    Primary completion :
    02/28/2026
    Completion :
    02/28/2026
    TP53
    |
    TP53 mutation • TP53 deletion
    |
    Venclexta (venetoclax) • azacitidine • magrolimab (ONO-7913)
    Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer (NCT02642042)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    07/18/2016
    Primary completion :
    05/15/2019
    Completion :
    03/05/2025
    KRAS • TP53 • STK11
    |
    TP53 mutation • KRAS mutation
    |
    Mekinist (trametinib) • docetaxel • omipalisib (GSK2126458)
    Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (NCT04599634)
    Phase 1
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    02/04/2025
    Initiation :
    12/16/2021
    Primary completion :
    03/29/2024
    Completion :
    06/20/2024
    TP53 • BCL2
    |
    TP53 mutation • CD20 positive
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • magrolimab (ONO-7913) • methylprednisolone acetate • methylprednisolone sodium succinate
    A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma (NCT05156268)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    01/27/2022
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    TP53 • MSI • POLE
    |
    TP53 mutation • MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia (NCI-2016-00797) (NCT02756897)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    01/31/2025
    Initiation :
    07/07/2016
    Primary completion :
    07/01/2025
    Completion :
    07/01/2025
    TP53 • IGH
    |
    TP53 mutation • Chr del(11q)
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib)
    Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL (15-H-0016) (NCT02337829)
    Phase 2
    Acerta Pharma BV
    Active, not recruiting
    Last update posted :
    01/30/2025
    Initiation :
    01/12/2015
    Primary completion :
    06/26/2020
    Completion :
    04/01/2026
    TP53
    |
    TP53 mutation
    |
    Calquence (acalabrutinib)
    Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT) (ACALLO) (NCT04716075)
    Phase 2
    Polish Lymphoma Research Group
    Completed
    Last update posted :
    01/16/2025
    Initiation :
    08/19/2019
    Primary completion :
    06/30/2024
    Completion :
    07/30/2024
    TP53
    |
    TP53 mutation
    |
    Calquence (acalabrutinib)
    Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer (NCT03715946)
    Phase 2
    Robert L. Ferris, MD, PhD
    Completed
    Last update posted :
    01/13/2025
    Initiation :
    11/16/2018
    Primary completion :
    03/31/2023
    Completion :
    03/31/2024
    TP53
    |
    TP53 mutation
    |
    Opdivo (nivolumab)
    A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients with High Risk CLL (CLL16) (NCT05197192)
    Phase 3
    German CLL Study Group
    Recruiting
    Last update posted :
    12/30/2024
    Initiation :
    04/19/2022
    Primary completion :
    05/01/2028
    Completion :
    05/01/2028
    TP53 • BCL2
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) (NCT04585750)
    Phase 1/2
    PMV Pharmaceuticals, Inc
    Recruiting
    Last update posted :
    12/04/2024
    Initiation :
    10/29/2020
    Primary completion :
    03/17/2026
    Completion :
    07/14/2026
    TP53
    |
    TP53 mutation • TP53 Y220C
    |
    Keytruda (pembrolizumab) • rezatapopt (PC14586)
    18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients with EGFR Activated Recurrent Glioblastoma (NCI-2018-02010) (NCT03732352)
    Phase 2
    Jonsson Comprehensive Cancer Center
    Completed
    Last update posted :
    11/12/2024
    Initiation :
    11/28/2018
    Primary completion :
    01/31/2024
    Completion :
    01/31/2024
    EGFR • TP53
    |
    TP53 mutation • EGFR mutation • EGFR amplification
    |
    Tagrisso (osimertinib)
    Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping (NCT04318938)
    Phase 2
    Institut für Klinische Krebsforschung IKF GmbH ...
    Active, not recruiting
    Last update posted :
    10/14/2024
    Initiation :
    03/30/2020
    Primary completion :
    01/16/2026
    Completion :
    01/16/2026
    ALK • TP53
    |
    TP53 mutation • ALK positive • ALK rearrangement • ALK fusion • ALK mutation
    |
    Alunbrig (brigatinib)
    Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (NCT03580928)
    Phase 2
    Dana-Farber Cancer Institute
    Active, not recruiting
    Last update posted :
    07/30/2024
    Initiation :
    08/07/2018
    Primary completion :
    04/10/2024
    Completion :
    12/31/2027
    TP53 • BCL2
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
    PREventing Second Cancers With DOSTARlimab (PREDOSTAR) (NCT05855811)
    Phase 2
    Centre Leon Berard
    Recruiting
    Last update posted :
    07/15/2024
    Initiation :
    07/26/2023
    Primary completion :
    07/26/2028
    Completion :
    03/26/2029
    TP53 • BRCA • IL2
    |
    TP53 mutation • BRCA mutation
    |
    Jemperli (dostarlimab-gxly)
    RP-6306 in Patients With Advanced Cancer (NCT05605509)
    Phase 2
    Canadian Cancer Trials Group
    Recruiting
    Last update posted :
    06/12/2024
    Initiation :
    05/24/2023
    Primary completion :
    12/01/2024
    Completion :
    06/01/2025
    HER-2 • KRAS • TP53 • CCNE1 • UGT1A1
    |
    TP53 mutation • KRAS mutation • HER-2 amplification • RAS mutation • CCNE1 amplification • UGT1A1*28 • UGT1A1*1*1
    |
    Herceptin (trastuzumab) • gemcitabine • 5-fluorouracil • irinotecan • leucovorin calcium • lunresertib (RP-6306)
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (NCT03964233)
    Phase 1
    Boehringer Ingelheim
    Active, not recruiting
    Last update posted :
    06/11/2024
    Initiation :
    06/11/2019
    Primary completion :
    09/03/2024
    Completion :
    05/30/2026
    TP53 • MDM2
    |
    TP53 mutation • TP53 wild-type • TP53 amplification
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma (NCI-2015-00960) (NCT02427620)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    06/10/2024
    Initiation :
    06/03/2015
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    TP53 • MYC • CD20
    |
    TP53 mutation • CD20 positive
    |
    Imbruvica (ibrutinib) • Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • vincristine • daunorubicin • dexamethasone • Truxima (rituximab-abbs) • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • Hemady (dexamethasone tablets) • GB241 (rituximab biosimilar) • Novex (rituximab biosimilar) • Starasid (cytarabine ocfosfate) • cyclophosphamide intravenous • dexamethasone injection • methotrexate IV
    Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCI-2014-00620) (NCT02101775)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    07/21/2014
    Primary completion :
    02/03/2022
    Completion :
    02/20/2025
    TP53
    |
    TP53 mutation
    |
    gemcitabine • adavosertib (AZD1775) • liposomal gemcitabine (FF-10832)