Clinical trials: TP53 Gene Mutation
Advanced Soft Tissue Sarcoma, Undifferentiated Pleomorphic Sarcoma (UPS)
Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma
This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene.
- Conditions
- Advanced Soft Tissue Sarcoma, Undifferentiated Pleomorphic Sarcoma (UPS), Myxofibrosarcoma (MFS)
- Trial name
- NCT06370871
- Testing
- Brigimadlin, Ezabenlimab, Gemcitabine
- Sponsor
- Boehringer Ingelheim
Hepatic Cancer, Hepatic Resection
Immunohistochemical Algorithm for the Diagnosis and Classification of Hepatocellular Carcinomas With TERT, TP53 and CTNNB1 Mutation
The presence of certain mutations in HCC, such as TERT and TP53, have a suspected or proven prognostic role in resected patients, but lack a morphological or immunophenotypic counterpart, which would allow us to define which…
- Trial name
- NCT06718153
- Testing
- Immunohistochemistry and in situ hybridisation analysis
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Astrocytoma, Glioblastoma
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance imaging (MRI).
- Conditions
- Astrocytoma, Glioblastoma, Glioma
- Trial name
- NCT00001148
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Li-Fraumeni Syndrome, Hereditary Cancer Syndromes
Biomarker Monitoring in TP53 Mutation Carriers
Purpose This study is an 'N-of-one' observational study focusing on individuals with a hereditary predisposition to cancer due to a genetic mutation in the TP53 gene.
- Conditions
- Li-Fraumeni Syndrome, Hereditary Cancer Syndromes, TP53 Gene Germline Mutation Carrier
- Trial name
- NCT02289326
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Scripps Health
High Grade Serous Ovarian Cancer, Cervical Cancer Screening
Routine Shallow-coverage Whole Genome Sequencing Testing of Liquid-based Cervical Smears for the Early Diagnosis of Ovarian Cancer
High-grade serous ovarian carcinoma (HGSOC) is the deadliest gynaecological tumour. The 5-year overall survival rate for advanced-stage disease is less than 30 per cent, due to diagnosis at an advanced stage.
- Conditions
- High Grade Serous Ovarian Cancer, Cervical Cancer Screening, Whole Genome Sequencing, Genomic Instability
- Trial name
- SHALLOW ROUTE (NCT07821879)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer, Breast Cancer and Pregnancy
Pregnancy Outcomes After Breast Cancer in Young Women With Germline Pathogenic Variants in Genes Other Than BRCA
The present study aims to refine the understanding of the prognostic impact of pregnancy after breast cancer in young women harboring germline pathogenic variants in breast cancer susceptibility genes other than BRCA
- Trial name
- Beyond BCY (NCT07591532)
- Volunteers
- 2,200 people
- Sponsor
- Jules Bordet Institute
Lymphadenectomy, Endometrial Cancer
SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial
This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations.
- Conditions
- Lymphadenectomy, Endometrial Cancer, Gene, p53, Sentinel Lymph Node Biopsy (SLNB)
- Trial name
- SENTIMETREP53 (NCT06900582)
- Testing
- Sentinel Lymph Node Mapping, Comprehensive pelvic and para-aortic lymphadenectomy
- Volunteers
- 374 people
- Sponsor
- University Hospital, Strasbourg, France
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
B-Cell Chronic Lymphocytic Leukemia, B-Lymphocytic Leukemia, Chronic
Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Background: Chronic lymphocytic leukemia and small lymphocytic lymphoma (hereby referred as CLL) are tumors of B cells. A subset of patients categorized as high-risk CLL has a poor clinical outcome when treated with conventional…
- Conditions
- B-Cell Chronic Lymphocytic Leukemia, B-Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Leukemia, Chronic Lymphatic
- Trial name
- NCT03204188
- Testing
- Ibrutinib, Fludarabine, Pembrolizumab
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Tumors, Ovarian Cancer
Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors
Primary Objectives are to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 and ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant…
- Conditions
- Tumors, Ovarian Cancer, Breast Cancer, Lung Cancer
- Trial name
- NCT05431582
- Testing
- ZN-c3, Bevacizumab, Pembrolizumab
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia or Myelodysplastic Syndromes
APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant
A multi-center, open label, Phase II clinical trial to assess the safety and efficacy of APR-246 in combination with azacitidine as maintenance therapy after allogeneic HSCT (hematopoietic stem cell transplant) for patients with…
- Trial name
- NCT03931291
- Testing
- APR-246
- Where
- 7 sites in United States
- Volunteers
- 33 people
- Sponsor
- Aprea Therapeutics
Advanced Solid Tumor, CDKN2A
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in patients with advanced solid tumors with confirmed…
- Conditions
- Advanced Solid Tumor, CDKN2A, NSCLC, Urothelial Carcinoma Bladder
- Trial name
- NCT06090318
- Testing
- Milademetan, Atezolizumab
- Sponsor
- Rain Oncology Inc
Chronic Lymphocytic Leukemia (CLL)
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a…
- Trial name
- CRISTALLO (NCT04285567)
- Testing
- Obinutuzumab, Venetoclax, Fludarabine
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 166 people
- Sponsor
- Hoffmann-La Roche
Colorectal Cancer Metastatic, Colorectal Cancer Stage IV
The p53 Colorectal Cancer Trial
Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e.
- Conditions
- Colorectal Cancer Metastatic, Colorectal Cancer Stage IV, TP53 Gene Mutation
- Trial name
- NCT03149679
- Testing
- Cyclophosphamide
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Haukeland University Hospital
Mitochondrial Disorders, Li-Fraumeni Syndrome
Role of p53 Gene in Metabolism Regulation in Patients With Li-Fraumeni Syndrome
This study will examine metabolic and biological factors in people with Li-Fraumeni syndrome, a rare hereditary disorder that greatly increases a person's susceptibility to cancer.
- Conditions
- Mitochondrial Disorders, Li-Fraumeni Syndrome, Carriers of p53 Mutation
- Trial name
- NCT00406445
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Ropeginterferon, Alfa-2b
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML With TP53 Mutations
To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS/AML with TP53 mutations.
- Conditions
- Ropeginterferon, Alfa-2b, Azacitidine, MDS/AML
- Trial name
- NCT07646821
- Testing
- ropeginterferon alfa- 2b, Azacitidine (AZA)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Solid Tumor, Adult, Lung Adenocarcinoma
TP53 R248Q TCR-T Cell Therapy for Advanced Solid Tumor
To evaluate the safety and efficacy of T cell therapy with mutated TP53 R248Q specific TCR transduction in patients with advanced solid tumor expressing the TP53 R248Q mutation and the HLA-A*11:01 allele.
- Conditions
- Solid Tumor, Adult, Lung Adenocarcinoma, Pancreas Cancer, Colorectal Cancer
- Trial name
- NCT06619886
- Testing
- Autologous, engineered T Cells targeting TP53 R248Q
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Chronic Lymphocytic Leukemia in Relapse, Chronic Lymphocytic Leukemia in Remission
A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations
The aim of the current trial is to evaluate if combination treatment with venetoclax + ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (RR CLL) can lead to MRD negativity, which may induce long…
- Trial name
- NCT03226301
- Testing
- Ibrutinib + Venetoclax 15 cycles, Ibrutinib until progression/relapse, Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles
- Where
- 49 sites in Belgium, Denmark and 4 more
- Volunteers
- 230 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
Colorectal Cancer, APC Gene Mutation
Patogenic Mutation in 5 Genes
This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.
- Conditions
- Colorectal Cancer, APC Gene Mutation, TP53 Gene Mutation, PIK3CA Gene Mutation
- Trial name
- NCT04976439
- Testing
- co-occuring mutation
- Where
- Indonesia
- Volunteers
- 22 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Education
Transition From Research to Disclosure in Human Genetics
The goal of this study is to design a means of providing research families, from diverse geographical locations, the chance to receive genetic testing after having been educated by video, and meetings or telephone conversations…
- Trial name
- NCT00505466
- Testing
- Genetic Counseling
- Where
- United States
- Volunteers
- 577 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center