Molecular Profile Detail

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Profile Name RB1 positive
Gene Variant Detail

RB1 positive (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CDKN2A del RB1 pos glioblastoma predicted - sensitive Ribociclib Phase 0 Actionable In a Phase 0 trial, Kisqali (ribociclib) demonstrated good CNS penetration and inhibited Rb1 phosphorylation and tumor cell proliferation, resulted in a median progression-free survival of 9.7 weeks and a median overall survival of 7.8 months in patients (n=6) with recurrent glioblastoma with intact Rb1 expression and harboring deletion of CDKN2A or amplification of CDK4 or CDK6 (PMID: 31285369; NCT02933736). 31285369
BRAF V600E/K CDKN2A loss RB1 pos melanoma predicted - sensitive Palbociclib + Vemurafenib Phase Ib/II Actionable In a phase I/II trial, Ibrance (palbociclib) plus Zelboraf (vemurafenib) was safe and resulted in an overall response rate (ORR) of 26.7% (4/15), disease control rate (DCR) of 80% (12/15), and progression-free survival (PFS) of 2.8 mo in metastatic melanoma patients with prior BRAF inhibitor treatment and BRAF V600E/K, CDKN2A loss, and RB1 expression, and an ORR of 27.8% (5/18), DCR of 83.3% (10/18) and 2.8 mo PFS when combined with pts without prior BRAF inhibitor treatment (PMID: 33947696; NCT02202200). 33947696
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01356628 Phase II Palbociclib A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer Active, not recruiting USA 0
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Terminated USA 0
NCT03009201 Phase I Doxorubicin + Ribociclib Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery Active, not recruiting USA 0
NCT01522989 Phase I Fluorouracil + Oxaliplatin + Palbociclib PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies Unknown status USA 0
NCT03114527 Phase II Everolimus + Ribociclib Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) Active, not recruiting USA 0
NCT02933736 Phase 0 Ribociclib Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients Recruiting USA 0
NCT03781960 Phase II Abemaciclib + Nivolumab Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma Completed USA 0
NCT02030483 Phase I Palbociclib Dexamethasone Lenalidomide Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma Terminated USA 0
NCT02555189 Phase Ib/II Ribociclib Enzalutamide Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression Recruiting USA 0
NCT02255461 Phase I Palbociclib Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors Terminated USA 0
NCT02524119 Phase II Ribociclib LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) Terminated USA 0
NCT04316169 Phase I Abemaciclib + Anastrozole + Hydroxychloroquine Abemaciclib + Fulvestrant + Hydroxychloroquine Abemaciclib + Hydroxychloroquine Abemaciclib + Hydroxychloroquine + Letrozole Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer Recruiting USA 0
NCT02599363 Phase I Paclitaxel + Ribociclib A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer Completed USA 0
NCT02334527 Phase II Palbociclib Phase II Trial of Palbociclib (PD-0332991) in Patients With Metastatic Urothelial Cancer (UC) After Failure of First-Line Chemotherapy Terminated USA 0
NCT03526250 Phase II Palbociclib Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) Active, not recruiting USA 1
NCT03355794 Phase I Everolimus + Ribociclib A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG) Active, not recruiting USA 0
NCT04391595 Phase I Abemaciclib + LY3214996 LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients Recruiting USA 0
NCT03834740 Phase I Everolimus + Ribociclib A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection Active, not recruiting USA 0
NCT04040205 Phase II Abemaciclib Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Recruiting USA 0
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting USA 1
NCT03110744 Phase II Palbociclib CDK4/6 Inhibition in Locally Advanced/Metastatic Chordoma (NCT-PMO-1601) Recruiting DEU 0
NCT03535506 Phase II Palbociclib Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (WI223281) Recruiting USA 0