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Therapy Name Everolimus
Synonyms
Therapy Description

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 (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Everolimus Afinitor RAD001|Zortress mTORC1 Inhibitor 9 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 (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
HRAS mutant Advanced Solid Tumor predicted - sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, human solid tumor cell lines harboring HRAS mutations demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) in culture compared to cell lines with wild-type HRAS (PMID: 26544513). 26544513
TSC2 inact mut Advanced Solid Tumor no benefit Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment resulted in limited activity with an objective response rate of 7% (2/30, 2 partial responses), stable disease in an additional 40% (12/30), a clinical benefit rate of 13% (4/30), a median progression-free survival of 2.3 months, and a median overall survival of 7.3 months in patients with advanced solid tumors harboring inactivating TSC1 or TSC2 mutations or activating MTOR mutations (PMID: 33727259; NCT02201212). 33727259
PIK3CA E545K breast cancer sensitive Everolimus Preclinical Actionable In a preclinical study, breast cancer cell lines harboring a PIK3CA E545K mutation had increased sensitivity to Afinitor (everolimus) in culture (PMID: 20664172). 20664172
TSC1 E636fs bladder carcinoma sensitive Everolimus Case Reports/Case Series Actionable A retrospective study of a Phase II trial correlated increased sensitivity to the mTOR inhibitor Afinitor (everolimus) with TSC1 mutations in bladder cancer patients, including one patient harboring TSC1 E636fs* who had a durable complete response (PMID: 22923433). 22923433
PTEN negative renal cell carcinoma predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a clinical study, negative PTEN IHC staining were detected more frequently in patients with renal cell carcinoma who responded to treatment with Afinitor (everolimus) or Torisel (temsirolimus) (odds ratio = 0.24, p=0.029) than those who did not respond (PMID: 31335987). 31335987
TSC2 R611W giant cell glioblastoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical case study, Afinitor (everolimus) treatment with adjuvant electromagnetic field therapy resulted in complete remission ongoing 33 months after diagnosis in a patient with gigantocellular glioblastoma harboring TSC2 R611W who was previously treated with surgical resection and radiotherapy (PMID: 31154346). 31154346
TSC2 E96* hepatocellular carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical study, a hepatocellular carcinoma patient harboring TSC2 E96* achieved stable disease following treatment with Afinitor (everolimus) (PMID: 30373752). 30373752
PIK3CA act mut Advanced Solid Tumor sensitive Everolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Afinitor (everolimus) demonstrated efficacy in multiple cancer cell lines in culture and xenograft models with PIK3CA activating mutations (PMID: 20664172). 20664172
TSC1 mutant bladder carcinoma sensitive Everolimus Phase II Actionable A retrospective study of a Phase II trial correlated increased sensitivity to the mTOR inhibitor Afinitor (everolimus) with TSC1 mutations in bladder cancer patients (PMID: 22923433). 22923433
BRAF V600E PTEN loss melanoma predicted - resistant Everolimus Case Reports/Case Series Actionable In a retrospective analysis, a melanoma patient harboring PTEN loss and BRAF V600E demonstrated resistance to Afinitor (everolimus) treatment, resulting in progressive disease (PMID: 20664172). 20664172
HRAS Q61L Advanced Solid Tumor sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing HRAS Q61L demonstrated sensitivity to growth inhibition by Afinitor (everolimus) in culture (PMID: 26544513). 26544513
HRAS Q61R Advanced Solid Tumor sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing HRAS Q61R demonstrated sensitivity to growth inhibition by Afinitor (everolimus) in culture (PMID: 26544513). 26544513
PIK3CA M1043I PIK3CA amp bladder urothelial carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic urothelial bladder cancer harboring PIK3CA M1043I and PIK3CA amplification (copy number >20), as well as amplification of CCND1 and loss of CDKN2A and CDKN2B, was treated with Afinitor (everolimus) and achieved a complete response including remission of lymph node metastases, and remained progression-free at 6 months (PMID: 33745098). 33745098
NRAS G13D B-cell acute lymphoblastic leukemia no benefit Everolimus Case Reports/Case Series Actionable In a clinical study, a pediatric patient with relapsed B-cell acute lymphoblastic leukemia harboring NRAS G13D, who also harbored SETD2 L1778fs* and an IKZF1 deletion, was treated with Afinitor (everolimus) in combination with chemotherapy and experienced persistent disease, and the patient died 6 months later (PMID: 33563661; NCT02670525). 33563661
PIK3CA mutant Her2-receptor negative breast cancer no benefit Everolimus Phase III Actionable In a retrospective analysis of a Phase III trial (BOLERO-2), the presence of PIK3CA mutations did not significantly affect the efficacy of Afinitor (everolimus) in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer, with a HR for progression-free survival of 0.37 in PIK3CA wild-type group and a HR of 0.51 (p=0.35) in patients with PIK3CA mutations (PMID: 26503204; NCT00863655). 26503204
PIK3CA act mut PTEN dec exp renal cell carcinoma no benefit Everolimus Case Reports/Case Series Actionable In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Afinitor (everolimus) had no difference in progression-free survival when stratified by the presence (n=21) or absence (n=17) of PIK3CA activating mutations (PMID: 26951309). 26951309
PTEN loss renal cell carcinoma predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, loss of PTEN expression was associated with improved progression-free survival compared to PTEN positive (10.5 vs 5.3 months) in renal cell carcinoma patients treated with Afinitor (everolimus) (PMID: 30327302). 30327302
PTEN loss clear cell renal cell carcinoma sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, Afinitor (everolimus) inhibited cell proliferation in PTEN-deficient clear cell renal carcinoma cell lines in culture (PMID: 35165399). 35165399
TSC1 mutant renal cell carcinoma conflicting Everolimus Case Reports/Case Series Actionable In a clinical study, treatment with Afinitor (everolimus) or Torisel (temsirolimus) resulted in more partial responses (odds ratio = 0.08, p=0.030) in patients with renal cell carcinoma harboring mTOR pathway mutations, including MTOR (n=8), TSC1 (n=1), and TSC2 (n=2), than those without mutations (n=76) (PMID: 31335987). 31335987
TSC1 mutant renal cell carcinoma conflicting Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, TSC1, TSC2, or MTOR mutation status was not associated with progression-free survival in renal cell carcinoma patients treated with Afinitor (everolimus) (PMID: 30327302). 30327302
PIK3CA H1047R Her2-receptor negative breast cancer no benefit Everolimus Phase III Actionable In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated comparable progression-free survival benefit in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring wild-type (HR=0.43) or mutant (HR=0.37) PIK3CA, similar benefit was observed in subgroups harboring PIK3CA H1047R (HR=0.37) and PIK3CA E545K/E542K (HR=0.30) (PMID: 28183140; NCT00863655). 28183140
PIK3CA E453Q PIK3CA H1047R breast cancer sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E453Q and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
TSC1 R98* hepatocellular carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical study, a hepatocellular carcinoma patient harboring TSC1 R98* achieved stable disease following treatment with Afinitor (everolimus) (PMID: 30373752). 30373752
TSC1 inact mut renal cell carcinoma predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, 28% (12/43) of metastatic renal cell carcinoma patients who responded to rapalogs, Afinitor (everolimus) or Torisel (temsirolimus), harbored inactivating TSC1, TSC2 mutations and/or activating MTOR mutations, compared to 11% (4/36) in patients who did not respond to therapy (PMID: 26831717). 26831717
PIK3CA H1047R estrogen-receptor positive breast cancer predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, combination of Afinitor (everolimus) and hormone therapy resulted in improved median progression-free survival (8.8 vs 4.1 months, p=0.02) in patients with hormone receptor-positive metastatic breast cancer harboring PIK3CA H1047R (n=6) compared to patients without PIK3CA H1047R (n=10) (PMID: 31088410). 31088410
BRAF V600E PIK3CA H1047R thyroid gland carcinoma resistant Everolimus Case Reports/Case Series Actionable In a clinical case study, a patient with anaplastic thyroid carcinoma co-harboring BRAF V600E and PIK3CA H1047R demonstrated resistance to treatment with Afinitor (everolimus) (PMID: 27797976). 27797976
TSC2 D1598fs TSC2 D1690fs hepatocellular carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical study, a hepatocellular carcinoma patient harboring TSC2 D1598fs and TSC2 D1690fs achieved stable disease following treatment with Afinitor (everolimus) (PMID: 30373752). 30373752
PIK3CA E545K Her2-receptor negative breast cancer no benefit Everolimus Phase III Actionable In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated comparable progression-free survival benefit in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring wild-type (HR=0.43) or mutant (HR=0.37) PIK3CA, similar benefit was observed in subgroups harboring PIK3CA H1047R (HR=0.37) and PIK3CA E545K/E542K (HR=0.30) (PMID: 28183140; NCT00863655). 28183140
PIK3CA exon21 Her2-receptor negative breast cancer no benefit Everolimus Phase III Actionable In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated greater benefit on progression-free survival in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring PIK3CA exon 10 (reported as exon 9) mutations (HR=0.26) compared to patients harboring PIK3CA exon 21 (reported as exon 20) mutations (HR=0.56) (PMID: 26503204; NCT00863655). 26503204
PIK3CA E545K PIK3CA M1043L breast cancer sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA M1043L in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
VHL mutant renal cell carcinoma sensitive Everolimus Phase I Actionable In a Phase I study, Afinitor (everolimus), as compared to Apitolisib (GDC-0980), resulted in a greater progression free survival and overall survival in patients with renal cell carcinoma harboring VHL mutations (J Clin Oncol 32:5s, 2014 (suppl; abstr 4525)). detail...
TSC2 mutant renal cell carcinoma conflicting Everolimus Case Reports/Case Series Actionable In a clinical study, treatment with Afinitor (everolimus) or Torisel (temsirolimus) resulted in more partial responses (odds ratio = 0.08, p=0.030) in patients with renal cell carcinoma harboring mTOR pathway mutations, including MTOR (n=8), TSC1 (n=1), and TSC2 (n=2), than those without mutations (n=76) (PMID: 31335987). 31335987
TSC2 mutant renal cell carcinoma conflicting Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, TSC1, TSC2, or MTOR mutation status was not associated with progression-free survival in renal cell carcinoma patients treated with Afinitor (everolimus) (PMID: 30327302). 30327302
PIK3CA exon10 Her2-receptor negative breast cancer predicted - sensitive Everolimus Phase III Actionable In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated greater benefit on progression-free survival in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring PIK3CA exon 10 (reported as exon 9) mutations (HR=0.26) compared to patients harboring PIK3CA exon 21 (reported as exon 20) mutations (HR=0.56) (PMID: 26503204; NCT00863655). 26503204
PIK3CA E545K PIK3CA E726K breast cancer sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA E726K in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
PIK3CA E726K PIK3CA H1047R breast cancer sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing PIK3CA E726K and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by Afinitor (everolimus) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
RET M918T medullary thyroid carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a Phase II clinical trial, Afinitor (everolimus) treatment resulted in stable disease in 71% (5/7) of medullary thyroid cancer patients, and 4 of the 7 patients harbored a RET M918T mutation (PMID: 26294908; NCT01118065). 26294908
PIK3CA mutant Erdheim-Chester disease sensitive Everolimus Guideline Actionable Afinitor (everolimus) is included in guidelines as first-line or subsequent-line therapy for patients with Erdheim-Chester disease harboring PIK3CA mutations (NCCN.org). detail...
RET mutant medullary thyroid carcinoma sensitive Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment resulted in stable disease in 71% (5/7) of medullary thyroid cancer patients, including patients harboring RET mutations, with median progression-free survival of 33 weeks (PMID: 26294908; NCT01118065). 26294908
VHL inact mut renal cell carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Afinitor (everolimus) had a trend towards improved in progression-free survival when stratified by the presence (median PFS=8.6 months, n=15) or absence (median PFS=5.5 months, n=16) of deleterious VHL mutations (PMID: 26951309). 26951309
PIK3CA act mut PTEN wild-type breast cancer sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, 8/9 breast cancer cell lines harboring a PIK3CA activating mutation and PTEN wild-type demonstrated sensitivity to treatment with Afinitor (everolimus) in culture, resulting in decreased cell viability (PMID: 21358673). 21358673
PTEN dec exp renal cell carcinoma no benefit Everolimus Case Reports/Case Series Actionable In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma treated with Afinitor (everolimus) had no difference in progression-free survival when stratified by high expression (n=17) and low expression (n=21) of Pten (PMID: 26951309). 26951309
TSC2 inact mut renal cell carcinoma predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, 28% (12/43) of metastatic renal cell carcinoma patients who responded to rapalogs, Afinitor (everolimus) or Torisel (temsirolimus), harbored inactivating TSC1, TSC2 mutations and/or activating MTOR mutations, compared to 11% (4/36) in patients who did not respond to therapy (PMID: 26831717). 26831717
PIK3CA H1047R progesterone-receptor positive breast cancer predicted - sensitive Everolimus Clinical Study - Cohort Actionable In a retrospective analysis, combination of Afinitor (everolimus) and hormone therapy resulted in improved median progression-free survival (8.8 vs 4.1 months, p=0.02) in patients with hormone receptor-positive metastatic breast cancer harboring PIK3CA H1047R (n=6) compared to patients without PIK3CA H1047R (n=10) (PMID: 31088410). 31088410
TSC1 inact mut Advanced Solid Tumor no benefit Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment resulted in limited activity with an objective response rate of 7% (2/30, 2 partial responses), stable disease in an additional 40% (12/30), a clinical benefit rate of 13% (4/30), a median progression-free survival of 2.3 months, and a median overall survival of 7.3 months in patients with advanced solid tumors harboring inactivating TSC1 or TSC2 mutations or activating MTOR mutations (PMID: 33727259; NCT02201212). 33727259
PTEN mutant endometrial cancer sensitive Everolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Afinitor (everolimus) inhibited growth of endometrial cancer cells harboring a PTEN nonsense mutation in culture and in xenograft models (PMID: 22662154). 22662154
PBRM1 mutant clear cell renal cell carcinoma conflicting Everolimus Phase II Actionable In a Phase II trial (RECORD-3), PBRM1 mutations were associated with longer first-line progression free survival (12.8 vs 5.5 months) in first-line Afinitor (everolimus)-treated clear cell renal cell carcinoma patients compared to first-line Sutent (sunitinib)-treated patients (PMID: 27751729). 27751729
PBRM1 mutant clear cell renal cell carcinoma conflicting Everolimus Clinical Study - Cohort Actionable In a clinical study, PBRM1 truncating mutations were not associated with progression-free survival or overall survival in clear cell renal cell carcinoma patients treated with Afinitor (everolimus) (n=193) (PMID: 31486842). 31486842
PTEN loss breast cancer resistant Everolimus Preclinical - Cell culture Actionable In a preclinical study, 10/12 breast cancer cell lines with PTEN loss demonstrated resistance to Afinitor (everolimus) in culture (PMID: 21358673). 21358673
PTEN E43fs choroid plexus carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical case study, adjuvant Afinitor (everolimus) treatment after surgery and radiotherapy resulted in stable disease in a patient with choroid plexus carcinoma harboring PTEN E43fs, who completed 12 months of therapy and remained in remission at 60 months after initial diagnosis (PMID: 37535883). 37535883
PIK3CA E542K Her2-receptor negative breast cancer no benefit Everolimus Phase III Actionable In a retrospective analysis of a Phase III trial (BOLERO-2), Afinitor (everolimus) demonstrated comparable progression-free survival benefit in patients with hormone receptor-positive, Erbb2 (Her2)-negative breast cancer harboring wild-type (HR=0.43) or mutant (HR=0.37) PIK3CA, similar benefit was observed in subgroups harboring PIK3CA H1047R (HR=0.37) and PIK3CA E545K/E542K (HR=0.30) (PMID: 28183140; NCT00863655). 28183140
TSC2 mutant subependymal giant cell astrocytoma predicted - sensitive Everolimus Phase III Actionable In a Phase III trial (EXIST-1), Afinitor (everolimus) treatment resulted in a 50% or more tumor reduction in 35% (27/78) of adult and pediatric patients diagnosed with tuberous sclerosis complex and had subependymal giant cell astrocytoma, compared to 0% (0/39) in the placebo group, 85% (99/117) of the patients harbored mutations in TSC1 and/or TSC2 (PMID: 23158522; NCT00789828). 23158522
HRAS G12V Advanced Solid Tumor sensitive Everolimus Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing HRAS G12V demonstrated sensitivity to growth inhibition by Afinitor (everolimus) in culture (PMID: 26544513). 26544513
TSC1 mutant subependymal giant cell astrocytoma predicted - sensitive Everolimus Phase III Actionable In a Phase III trial (EXIST-1), Afinitor (everolimus) treatment resulted in a 50% or more tumor reduction in 35% (27/78) of adult and pediatric patients diagnosed with tuberous sclerosis complex and had subependymal giant cell astrocytoma, compared to 0% (0/39) in the placebo group, 85% (99/117) of the patients harbored mutations in TSC1 and/or TSC2 (PMID: 23158522; NCT00789828). 23158522
TSC2 Q1178* thyroid cancer predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical case study, a thyroid cancer patient harboring TSC2 Q1178* demonstrated an 18-month response to Afinitor (everolimus) (PMID: 25295501; NCT00936858). 25295501
PIK3CA R88Q PTEN mut endometrial cancer sensitive Everolimus Preclinical Actionable In a preclinical study, Afinitor (everolimus) inhibited proliferation of endometrial cancer cells harboring PIK3CA R88Q and PTEN mutations in culture (PMID: 22662154). 22662154
PTEN loss transitional cell carcinoma predicted - resistant Everolimus Case Reports/Case Series Actionable In a Phase II trial, 57% (8/14) of transitional cell carcinoma patients that demonstrated uncontrolled disease after treatment with Afinitor (everolimus) harbored PTEN loss, while 0% (0/6) of patients with controlled disease demonstrated evidence of PTEN loss (PMID: 22473592). 22473592
PTEN loss Advanced Solid Tumor no benefit Everolimus Phase II Actionable In a Phase II trial, Afinitor (everolimus) treatment in patients with advanced solid tumors harboring PTEN loss did not reach its primary endpoint, resulting in only stable disease or progressive disease (PMID: 28330462). 28330462
PTEN N323fs castration-resistant prostate carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a clinical case study, Afinitor (everolimus) treatment resulted in stable disease for eight months in a patient with castration-resistant prostate cancer harboring PTEN N323fs*21 who had previously progressed on several lines of therapy (PMID: 32399016). 32399016
RET C620R medullary thyroid carcinoma predicted - sensitive Everolimus Case Reports/Case Series Actionable In a Phase II clinical trial, Afinitor (everolimus) treatment resulted in stable disease of 116 weeks in a MEN2A patient with medullary thyroid cancer harboring a RET C620R mutation (PMID: 26294908; NCT01118065). 26294908
PBRM1 inact mut renal cell carcinoma no benefit Everolimus Case Reports/Case Series Actionable In a retrospective analysis from a Phase II clinical trial, patients with metastatic renal cell carcinoma had no difference in progression-free survival when stratified by the presence (n=6) or absence (n=22) of deleterious PBRM1 mutation when treated with Afinitor (everolimus) (PMID: 26951309). 26951309

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02269670 Phase II Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole Phase II Study of Everolimus Beyond Progression Terminated USA 0
NCT02015728 Phase I Erlotinib Everolimus Dasatinib Etoposide + Temozolomide Sorafenib Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors Unknown status USA 0
NCT02273752 Phase II Everolimus Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer Terminated USA 0
NCT01111058 Phase II Everolimus Everolimus Versus Placebo in Head and Neck Cancer Terminated USA 0
NCT03458221 Phase II Itraconazole Everolimus Letrozole Bicalutamide Signal TrAnsduction Pathway Activity Analysis in OVarian cancER (STAPOVER) Recruiting NLD 0
NCT06126588 Phase II Everolimus Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial (ELUMEN) Not yet recruiting FRA 0
NCT02687958 Phase II Everolimus Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin Active, not recruiting ITA 0
NCT02155920 Phase II Everolimus Everolimus for Children With Recurrent or Progressive Ependymomaildren With Recurrent or Progressive Ependymoma Completed USA 0
NCT02724020 Phase II Sapanisertib + Serabelisib Sapanisertib Everolimus MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Completed USA | POL | ITA | GBR | FRA | ESP | CZE | CAN 0
NCT02254239 Phase I Everolimus Everolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma Terminated USA 0
NCT01217931 Phase II Everolimus Pazopanib Bevacizumab Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy Active, not recruiting USA 0
NCT02143726 Phase II Sorafenib Everolimus Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Thyroid Cancer Unknown status USA 0
NCT04185831 Phase II Atezolizumab Niraparib Cobimetinib Everolimus A MolEcularly Guided Anti-Cancer Drug Off-Label Trial (MEGALiT) Active, not recruiting SWE 0
NCT01215136 Phase II Everolimus Paclitaxel First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma Terminated USA 0
NCT02205515 Phase Ib/II Everolimus An Open Label, Single-Centre, Phase II Study of Everolimus With EBRT for the Treatment of mNET Liver Metastasis Completed CAN 0
NCT02031536 Phase II Everolimus Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery Terminated USA 0
NCT02023905 Phase II Temozolomide Everolimus Everolimus With and Without Temozolomide in Adult Low Grade Glioma Terminated USA 0
NCT01218555 Phase I Lenalidomide Everolimus Study of Everolimus (RAD001)in Combination With Lenalidomide Completed USA 0
NCT02352844 Phase II Everolimus Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations Completed USA 0
NCT05476939 Phase III Everolimus ONC201 Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) Recruiting SWE | FRA | ESP | DNK 0
NCT02560012 Phase II Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib Personalized Targeted Inhibitors Treatment in Renal Cell Cancer Terminated USA 0
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Terminated USA 0
NCT05432518 Phase I Olaparib Palbociclib Afatinib Everolimus Dasatinib GBM Personalized Trial Recruiting CAN 0
NCT01133678 Phase II Cetuximab + Cisplatin + Paclitaxel Everolimus Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck Terminated USA 0
NCT01880749 Phase I Everolimus Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas Completed USA 0
NCT02201212 Phase II Everolimus Everolimus for Cancer With TSC1 or TSC2 Mutation Completed USA 0
NCT01865747 Phase III Everolimus Cabozantinib A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma Completed USA | TUR | SWE | SVK | POL | NLD | ITA | IRL | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUT | AUS | ARG 5
NCT04195750 Phase III Belzutifan Everolimus A Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) Active, not recruiting USA | TUR | SWE | NOR | ITA | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA 8
NCT01827384 Phase II Adavosertib + Carboplatin Temozolomide + Veliparib Everolimus Trametinib Molecular Profiling-Based Targeted Therapy in Treating Patients With Advanced Solid Tumors Completed USA 0
NCT02236572 Phase II Everolimus Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score Terminated USA 0
NCT02531932 Phase II Carboplatin Everolimus Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer Active, not recruiting USA 0
NCT02315625 Phase II Everolimus Sunitinib Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery Terminated USA 0
NCT02089334 Phase Ib/II Everolimus + RX-0201 Everolimus Dose-Finding, Safety and Efficacy Study of RX-0201 Plus Everolimus in Metastatic Renal Cell Cancer Terminated USA 0
NCT01120249 Phase III Everolimus S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery (S0931) Active, not recruiting USA 1
NCT02504892 Phase II Everolimus Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer Terminated USA 0
NCT03049189 Phase III 177Lu-edotreotide Everolimus Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE) Active, not recruiting USA | POL | NLD | ITA | GBR | FRA | ESP | DEU | CZE | CHE | BEL | AUT | AUS 1
NCT01797523 Phase II Letrozole Everolimus Metformin RAD/Letrozole/Metformin Active, not recruiting USA 0
NCT02397083 Phase II Everolimus Phase II Study of Intrauterine Device (IUD) Alone or in Combination With Everolimus in Endometrial Cancer Active, not recruiting USA 0
NCT05725200 Phase II Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) Recruiting NOR 0
NCT03578432 Phase I Everolimus Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy Terminated USA 0
NCT01548807 Phase I Everolimus Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy Completed USA 0
NCT01087554 Phase I Temsirolimus Everolimus Sirolimus Vorinostat Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer Active, not recruiting USA 0
NCT01931163 Phase II Everolimus NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer Completed USA 0
NCT02332902 Phase II Everolimus Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T Completed USA 0
NCT01700400 Phase I Carboplatin Everolimus Bevacizumab Pemetrexed Disodium Study of Everolimus, Pemetrexed, Carboplatin, and Bevacizumab to Treat Stage IV Lung Cancer Completed USA 0
NCT02387099 Phase II Everolimus Dose EScalation Induction of EvERolimus (Desiree) Completed DEU 0
NCT01197170 Phase I Erlotinib Everolimus Sorafenib Anastrozole Bevacizumab Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Completed USA 0
NCT05477576 Phase Ib/II Everolimus Lanreotide acetate RYZ101 Sunitinib Octreotide acetate Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (ACTION-1) Recruiting USA | NLD | FRA | ESP | CAN | BRA | BEL 0
NCT04199026 Phase I Irinotecan Doxorubicin Ifosfamide Temozolomide Temsirolimus Ganitumab Pazopanib Everolimus Vincristine Sulfate Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma Not yet recruiting USA 0
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 Active, not recruiting USA 0
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Completed USA 0
NCT00823459 Phase II Everolimus Phase II Trial of RAD001 in Patients With Recurrent Low Grade Glioma Completed USA 0
NCT01508104 Phase Ib/II Dactolisib + Everolimus Everolimus Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors Terminated USA 0
NCT02539459 Phase II Everolimus Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus Terminated USA 0
NCT00912340 Phase II Everolimus Trastuzumab Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast Cancer Completed USA 0
NCT01637090 Phase II Everolimus Everolimus in Treating Cutaneous T-cell Lymphoma Terminated USA 0
NCT06472388 Phase II Everolimus Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors (EVENET) Recruiting BRA 0
NCT01674140 Phase III Goserelin Anastrozole Letrozole Leuprolide Everolimus Tamoxifen Exemestane S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3) Active, not recruiting USA 1
NCT04665739 Phase II Everolimus lutetium Lu 177 dotatate Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors Recruiting USA 0
NCT04919226 Phase III Fluorouracil + Leucovorin + Oxaliplatin 177Lu-edotreotide Everolimus Capecitabine + Temozolomide Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE) Recruiting USA | SWE | NLD | ITA | GBR | FRA | ESP | DEU | AUS 1
NCT02456857 Phase II Bevacizumab Everolimus Pegylated liposomal doxorubicin Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative Completed USA 0
NCT02450175 Phase I Letrozole Everolimus Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls Unknown status USA 0
NCT04591431 Phase II Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) Active, not recruiting ITA 0
NCT00831480 Phase II Everolimus Everolimus(RAD001) For Advanced Renal Cell Carcinoma(RCC)Before Kidney Removal Terminated USA 0
NCT01665768 Phase II Rituximab Everolimus Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma Completed USA 0
NCT00610948 Phase I Everolimus Panitumumab Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Solid Tumors That Did Not Respond to Treatment Completed USA 0
NCT01523977 Phase I Prednisone Everolimus Vincristine Sulfate Doxorubicin Pegaspargase Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL Completed USA 0
NCT01270321 Phase II Pasireotide Everolimus A Trial of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer Completed USA 0
NCT05918302 Phase III 177Lu-edotreotide Everolimus Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus. (LEVEL) Recruiting ITA | FRA | ESP 0
NCT01734512 Phase II Everolimus PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children Completed USA 0
NCT01603004 Phase I Everolimus Sunitinib Potential Imaging and Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors Completed USA 0
NCT03163667 Phase II Everolimus + Telaglenastat Everolimus CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC Completed USA 0
NCT01334502 Phase I Everolimus Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma Completed USA 0
NCT05188118 Phase I Cabozantinib Nivolumab Everolimus Ipilimumab Lenvatinib Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma Recruiting USA 0
NCT01345136 Phase II Everolimus Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma Terminated USA 0
NCT05773274 Phase Ib/II Everolimus lutetium Lu 177 dotatate Comparing Retreatment of 177Lu-DOTATATE PRRT Versus Everolimus in Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial Recruiting USA | CAN 0


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