Therapy Detail

Therapy Name Everolimus + Hydroxychloroquine
Therapy Description


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Drug Name Trade Name Synonyms Drug Classes Drug Description
Everolimus Afinitor RAD001|Zortress mTORC1 Inhibitor 8 Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex who have subependymal giant cell astrocytoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (
Hydroxychloroquine Plaquenil HCQ Plaquenil (hydroxychloroquine sulfate) increases intralysosomal pH, resulting in inhibition of autophagic protein degradation and accumulation of autophagosomes, which potentially leads to cell death in autophagy-dependent tumor cells (NCI Drug Dictionary).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown clear cell renal cell carcinoma not applicable Everolimus + Hydroxychloroquine Phase Ib/II Actionable In a Phase I/II trial, treatment with the combination of Afinitor (everolimus) and Plaquenil (hydroxychloroquine) was well-tolerated, and resulted in a median progression-free survival (PFS) of 6.3 months, PFS of 6 months or greater in 45% (15/33), and partial response (PR) or stable disease (SD) greater than 3 months in 66% (22/33; 2 PR and 20 SD) of clear cell renal cell carcinoma patients (PMID: 30635337). 30635337
Clinical Trial Phase Therapies Title Recruitment Status
NCT01510119 Phase Ib/II Everolimus + Hydroxychloroquine Autophagy Inhibition to Augment mTOR Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine in Patients With Previously Treated Renal Cell Carcinoma Completed
NCT03032406 Phase II Everolimus + Hydroxychloroquine Everolimus Hydroxychloroquine CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer Recruiting