Molecular Profile Detail

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Profile Name RAD51B inact mut
Gene Variant Detail

RAD51B inact mut (loss of function)

Relevant Treatment Approaches Olaparib

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
RAD51B inact mut prostate cancer sensitive Olaparib Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring RAD51B mutations (10.89 vs 1.77 mo) (PMID: 32343890; NCT02987543). detail... detail... 32343890
RAD51B inact mut prostate cancer sensitive Olaparib Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in RAD51B (NCCN.org). detail...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05379972 Phase II Olaparib + Pembrolizumab Phase II Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers Not yet recruiting USA 0
NCT02734004 Phase Ib/II Durvalumab + Olaparib Bevacizumab + Durvalumab + Olaparib A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA) Completed USA | FRA 5
NCT05010096 Phase I BAY1895344 + Copanlisib BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors Withdrawn 0
NCT03840967 Phase II Niraparib A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma Recruiting USA 0
NCT04171700 Phase II Rucaparib A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) Active, not recruiting USA 0
NCT04983745 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) Not yet recruiting USA 0
NCT05188508 Phase II Olaparib + Pembrolizumab + Temozolomide Pembrolizumab, Olaparib, and Temozolomide for People With Glioma Recruiting USA 0
NCT04053322 Phase II Durvalumab + Fulvestrant + Olaparib Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) Recruiting FRA 0
NCT05174455 Phase II Niraparib Niraparib for the Treatment of Leiomyosarcoma Not yet recruiting USA 0
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Recruiting USA 0
NCT04550494 Phase II Talazoparib Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations Recruiting USA 0
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting USA 0
NCT03377556 Phase II Talazoparib Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer Completed USA | CAN 0
NCT04253262 Phase Ib/II Copanlisib + Rucaparib A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Recruiting USA 0
NCT04826341 Phase Ib/II Berzosertib + Sacituzumab govitecan-hziy A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors Recruiting USA 0
NCT03209401 Phase I Carboplatin + Niraparib Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies Recruiting USA 0