Company
Novartis
18 active trials that select patients by a biomarker on marked.bio, across 9 biomarkers; 6 in phase 3.
Counts only trials this company leads as sponsor, not partnered or academic trials of its drugs.
Biomarkers
Drugs in these trials
Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).
alpelisib 5opnurasib 3trametinib 3fulvestrant 3ceritinib 2naporafenib 2ribociclib 2pembrolizumab 2dabrafenib 1trastuzumab 1pertuzumab 1batoprotafib 1tislelizumab 1midostaurin 1HRO761 1nazartinib 1capmatinib 1gefitinib 1IDH305 1nivolumab 1
Upcoming readouts
Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.
- 2027-01 Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. Phase 3 · PIK3CA activating mutation
- 2027-01 Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation Phase 1/2 · KRAS G12C
- 2027-01 Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer Phase 2 · PIK3CA activating mutation
- 2027-02 Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation Phase 3 · PIK3CA activating mutation
- 2027-02 Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma Phase 2 · BRAF V600E
- 2027-02 Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer Phase 2 · PIK3CA activating mutation
- 2027-06 Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study Phase 4 · ALK fusion
Trials
18 of 96 trials shown
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Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
ceritinib FDA EU
An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Jud…
ALK fusionALK Positive Malignancies
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Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
alpelisib FDA EU
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
PIK3CA activating mutationLymphatic Malformations
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Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
opnurasibdocetaxel
Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novart…
KRAS G12CNon-Small Cell Lung Cancer
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Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
dabrafenib FDA EUtrametinib FDA EU
BRAF V600E mutation-positive tumor sample as per central laboratory result
BRAF V600EDifferentiated Thyroid Cancer (DTC)
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Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
alpelisib FDA EUfulvestrant FDA EU
The presence of PIK3CA mutation(s) determined in tumor tissue prior to enrollment either by a Novartis designated laborat…
PIK3CA activating mutationBreast Cancer
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Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
alpelisib FDA EUtrastuzumabpertuzumab
Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or…
PIK3CA activating mutationAdvanced HER2+Breast Cancer
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Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
Presence of a KRAS G12C mutation (all participants) and:
KRAS G12CLocally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
opnurasibbatoprotafibtislelizumab
Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to…
KRAS G12CKRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung
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Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
alpelisib FDA EUfulvestrant FDA EU
Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory)
PIK3CA activating mutationBreast Neoplasms
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Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
alpelisib FDA EUfulvestrant FDA EU
Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory)
PIK3CA activating mutationAdvanced Breast Cancer
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Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
naporafenibLTT462trametinib FDA EUribociclib
Participants with BRAFV600 mutant disease:
BRAF V600EMelanoma
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A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
midostaurin FDA EUfludarabinecytarabinedaunorubicinidarubicinmitoxantroneetoposide
…Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
FLT3 mutation (ITD/TKD)FLT3-mutated Acute Myeloid Leukemia
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Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
[177Lu]Lu-DWJ155
Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Gastric/Gastroesophageal Junction (GEJ) Cancer, Bladder Cancer
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Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
HRO761pembrolizumab FDA EUirinotecan
Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy…
MSI-H / dMMRMSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
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A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
KFA115pembrolizumab FDA EU
…tive breast cancer, ovarian cancer (high-grade serous histology), anal cancer (squamous), MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC.
MSI-H / dMMRCarcinoma, Non-Small-Cell Lung, Cutaneous Melanoma, Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial
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Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
nazartinibtrametinibribociclibnaporafenibcapmatinibgefitinib FDA EU
…tologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.
EGFR exon 19 deletion / L858REGFR-mutant Non-small Cell Lung Cancer
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A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Documented IDH1R132-mutant tumors
IDH1/2 mutationAdvanced Malignancies That Harbor IDHR132 Mutations
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Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
ALK fusionALK-positive NSCLC
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Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
alpelisib FDA EUfulvestrant FDA EU
Participants with confirmed PIK3CA mutant advanced or metastatic breast cancer
PIK3CA activating mutationAdvanced Breast Cancer
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Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.
capmatinib FDA EU
…GFR wild type (EGFR Negative) and ALK rearrangement negative and who have tested positive MET exon14 skipping mutation (Locally available MET report either by reverse transcriptase polymeras…
MET exon 14 skippingNon-Small Cell Lung Carcinoma
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Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy
capmatinibosimertinib FDA EUpemetrexedcisplatincarboplatin
…ased Doublet Chemotherapy in Patients With Locally Advanced or Metastatic NSCLC Harboring EGFR Activating Mutations Who Have Progressed on Prior Generation EGFR-TKI Therapy and Whose Tumors Are T790M Muta…
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
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Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
capmatinibdocetaxel
… sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations.
EGFR exon 19 deletion / L858RMET exon 14 skippingCarcinoma, Non-Small-Cell Lung
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Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations
nazartiniberlotinib FDA EUgefitinib FDA EU
…ic, stage IIIB/ IIIC or stage IV NSCLC with documented EGFR activating mutation (L858R or ex19del)
EGFR exon 19 deletion / L858RCarcinoma, Non-small Cell Lung
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Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
dabrafenib FDA EUtrametinib FDA EU
V600E/K mutation positive using a validated local test
BRAF V600EMalignant Melanoma
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Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
ribociclibletrozolealpelisib FDA EUfulvestrant FDA EU
Patient has PIK3CA mutation as determined in tumor tissue and/or plasma by a Novartis designated laboratory.
PIK3CA activating mutationBreast Cancer
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Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
midostaurin FDA EUcytarabinedaunorubicinidarubicin
Patients must have a documented FLT3 mutation (ITD or TKD).).
FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia
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A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
spartalizumabdabrafenib FDA EUtrametinib FDA EU
Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
BRAF V600EMelanoma
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Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
dabrafenib FDA EUtrametinib FDA EUPlacebos
…IIIa \[lymph node metastasis \> 1 mm\], IIIb or IIIc) cutaneous melanoma determined to be V600E/K mutation positive using the bioMerieux (bMX) THxID BRAF Assay by a central laboratory.
BRAF V600EMelanoma
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LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
ceritinib FDA EUpemetrexedcisplatincarboplatin
…s of non-squamous Non-small cell lung cancer (NSCLC) that was Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test.
ALK fusionNon-Small Cell Lung Cancer
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LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
ceritinib FDA EUpemetrexeddocetaxel
…irmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
ALK fusionNon-Small Cell Lung Cancer
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A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
dabrafenib FDA EUtrametinib FDA EU
…a that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF …
BRAF V600EMelanoma
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Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
dabrafenib FDA EUvemurafenib FDA EUtrametinib FDA EU
Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma
BRAF V600EMelanoma
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Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
opnurasibtrametinibribociclibcetuximab
Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen a…
KRAS G12CKRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer
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Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
alpelisib FDA EUfulvestrant FDA EUmetforminDapagliflozin
Participant had a PIK3CA mutation(s) present in the tumor prior to enrollment.
PIK3CA activating mutationBreast Cancer
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Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
alpelisib FDA EUfulvestrant FDA EUGoserelin
…edicine Platform in Patients With HR-positive/HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial
PIK3CA activating mutationAdvanced Breast Cancer
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Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
capmatinib FDA EU
Participant must have MET exon 14 mutation and/or high-level MET amplification (MET: GCN ≥ 10) as determined by a CLIA cert…
MET exon 14 skippingNon-small Cell Lung Cancer
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Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
… sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations)
EGFR exon 19 deletion / L858RMET exon 14 skippingNon-Small Cell Lung Cancer (NSCLC)
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A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC
dabrafenib FDA EUtrametinib FDA EU
…tologically confirmed diagnosis of Stage IV NSCLC (according to AJCC 8th edition) that is BRAF V600E mutation-positive by local test result from a qualified assay (NMPA and/or MOH-approved)
BRAF V600ECarcinoma, Non-Small-Cell Lung
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A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases
capmatinib FDA EU
…ive as assessed by a validated test as part of the participant's standard of care and has MET∆ex14 mutation per Novartis-designated central laboratory or (US only) locally with FoundationO…
MET exon 14 skippingNon-small Cell Lung Carcinoma (NSCLC)
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HDM201 Added to CT in R/R or Newly Diagnosed AML
siremadlincytarabinedaunorubicinidarubicinmidostaurin FDA EUCPX-351posaconazolemidazolam
For Part 2 Expansion Cohort 2: documented presence of FLT3 mutation (ITD or TKD ) and suitable for midostaurin treatment as per investigator judgement.
FLT3 mutation (ITD/TKD)Leukemia, Myeloid, Acute
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Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC
dabrafenib FDA EUtrametinib FDA EU
Presence of a BRAF V600E mutation in lung cancer tissue.
BRAF V600ENon-Small-Cell Lung Cancer
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A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
midostaurin FDA EU
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia
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A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma
NIR178spartalizumab
…st have received anti-PD-1/PD-L1 single agent, or in combination with anti-CTLA-4 therapy BRAF V600E mutant patients: must have received prior anti-PD-1/PD-L1 single-agent, or in combination…
BRAF V600ENSCLC, Non Small Cell Lung Cancer, RCC, Renal Cell Cancer, Pancreatic Cancer, Urothelial Cancer
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Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
dabrafenib FDA EUtrametinib FDA EUcarboplatinvincristine
Diagnosis of BRAF V600 mutant High Grade glioma that had relapsed, progressed or failed to respond to frontline …
BRAF V600EDiffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
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Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
alpelisib FDA EUfulvestrant FDA EUletrozoleGoserelinLeuprolide
…th gene encoding the p110alpha catalytic subunit of PI3K (phosphatidylinositol-3-kinase) (PIK3CA) mutation.
PIK3CA activating mutationBreast Cancer
-
Ceritinib Rare Indications Study in ALK+ Tumors
ceritinib FDA EU
Patient has a histologically or cytologically confirmed diagnosis of ALK positive (ALK+) tumor other than Non-Small Cell Lung Cancer (NSCLC).
ALK fusionTumors With Aberrations in ALK, Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumor, Glioblastoma
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Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.
…nts in Phase Ib and Phase II Groups 1 to 4: locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation (or other rare activating mutations that …
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
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Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)
EGFR wt status (for exon 19 deletions and exon 21 L858R substitution mutations)
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
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Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer
…ticenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients …
EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
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Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
trametinib FDA EUdabrafenib FDA EU
B4: BRAF V600 mutant tumors.
BRAF V600ECancer
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Phase I/II Study of PDR001 in Patients With Advanced Malignancies
Patients with V600 mutation positive melanoma must have clinical or radiological evidence of disease progression duri…
BRAF V600EALK fusionMelanoma, Non-small Sell Lung Cancer (NSCLC), Triple Negative Breast Cancer, Anaplastic Thyroid Cancer
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LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.
ceritinib FDA EU
…ologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) tes…
ALK fusionNon-Small-Cell Lung Cancer
-
A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges
ceritinib FDA EU
In addition, the NSCLC must harbor an ALK rearrangement, as assessed using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecula…
ALK fusionALK-positive Non-small Cell Lung Cancer
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A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
…amenable to definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC.
EGFR exon 19 deletion / L858RAdvanced Non-small Cell Lung Cancer
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Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
dabrafenib FDA EUtrametinib FDA EU
Must have a a BRAF V600E mutation-positive tumor as confirmed by an approved local laboratory or a sponsor designa…
BRAF V600ECancer
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Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
dabrafenib FDA EUtrametinib FDA EU
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
BRAF V600EMelanoma and Brain Metastases
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Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma
dabrafenib FDA EUtrametinib FDA EU
…cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and BRAF V600 mutation-positive.
BRAF V600ECancer, Melanoma
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Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
alpelisib FDA EUbuparlisib
Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
PIK3CA activating mutationBreast Cancer
-
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
midostaurin FDA EU
Patients with a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be reque…
FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia
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BGJ398 for Patients With Tumors With FGFR Genetic Alterations
Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic alteration.
FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementSolid Tumor, Hematologic Malignancies
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Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
ceritinib FDA EU
Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive mutation, translocation, rearrangement or amplification.
ALK fusionROS1 fusionTumors With Aberrations in ALK or ROS1
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LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
ceritinib FDA EU
Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement defined as positive using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott M…
ALK fusionNon-Small Cell Lung Cancer
-
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
dabrafenib FDA EU
BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement Amendments (CLI…
BRAF V600ENeoplasms, Brain
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A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
capmatinibgefitinib FDA EU
Documented EGFR mutation
EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer
-
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
AUY922docetaxelpemetrexed
Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.
EGFR exon 19 deletion / L858RAdvanced Non Small Cell Lung Cancer (NSCLC)
-
BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
dabrafenib FDA EUtrametinib FDA EUpanitumumab
…nd Part 2: Histologically- or cytologically-confirmed diagnosis of advanced or metastatic BRAF V600E mutation positive CRC
BRAF V600ECancer
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A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
alpelisib FDA EUAMG 479
…wing histologically/cytologically-confirmed advanced solid tumors with documented somatic PIK3CA mutations or amplifications in tumor tissue:
PIK3CA activating mutationPIK3CA Mutated Advanced Solid Tumors, PIK3CA Amplified Advanced Solid Tumors
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LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
ceritinib FDA EU
…ologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
ALK fusionNon-Small Cell Lung Cancer
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LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
ceritinib FDA EU
…ologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carried an ALK rearrangement, as per the FDA-approved Vysis ALK break-apart FISH assay (Abbott Molecular Inc.)
ALK fusionNon-Small Cell Lung Cancer
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Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
dabrafenib FDA EUtrametinib FDA EU
Presence of a BRAF V600E mutation in lung cancer tissue.
BRAF V600ECancer
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A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.
AUY922
Patients enrolled to the fifth stratum, modified EGFR mutant, must have documented prior response to EGFR TKI as defined by CR, PR or SD for 6 months …
EGFR exon 19 deletion / L858RALK fusionNon-small-cell Lung Cancer
-
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
dabrafenib FDA EUtrametinib FDA EU
BRAF mutation positive melanoma or colorectal cancer
BRAF V600ECancer
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Phase II Study of TKI258 in Advanced Urothelial Carcinoma
TKI258
A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
FGFR3 alteration (mutation or fusion)Urothelial Cancer
-
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
midostaurin FDA EU
or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed …
FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
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PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
itraconazolemidostaurin FDA EU
Patients with a relevant FLT3-ITD mutation or D835Y point mutation
FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia, Myelodysplastic Syndromes
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Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors
topotecantemozolomideribociclib
Anaplastic astrocytoma, IDH-mutant
IDH1/2 mutationNeuroblastoma
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A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
dabrafenib FDA EULTT462trametinib FDA EUnaporafenibbatoprotafibspartalizumabtislelizumab
All patients must have a BRAF V600 mutation confirmed by local assessment.
BRAF V600EBRAF V600 Colorectal Cancer
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A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma
naporafenibLTT462trametinibribociclib
Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (cutaneous melanoma) in tumor tissue
KRAS G12DBRAF V600ENon-Small Cell Lung Cancer, Melanoma
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Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors
Advanced or metastatic KRAS-mutant CRC who have failed at least two prior systemic antineoplastic therapies in the advanced …
KRAS G12CKRAS G12DSolid Tumors for Phase Ib, Pancreatic Cancer for Phase II, Colorectal Cancer for Phase II
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Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations
Patients with confirmed KRAS-mutated NSCLC
KRAS G12CKRAS G12DNSCLC, Ovarian Cancer, Melanoma, Other Solid Tumors
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A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
Documentation of IDH1R132 mutation of tumor
IDH1/2 mutationAcute Myeloid Leukemia (AML)
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A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification
capmatiniberlotinib FDA EU
EGFR mutation (L858R and /or ex19del)
EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
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Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
ceritinib FDA EU
…agnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.
ALK fusionNon-Small Cell Lung Cancer
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A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
ceritinib FDA EUwarfarinmidazolam
…d is not a candidate for definitive multimodality therapy) or stage IV NSCLC demonstrated ALK-positive or an advanced tumor, other than NSCLC, that carries an ALK genetic alteration (mutation,…
ALK fusionALK-positive Advanced Tumors
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Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
ribociclibceritinib FDA EU
Patients must be diagnosed with ALK-positive advanced NSCLC.
ALK fusionNon-small Cell Lung Cancer
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Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies
CLR457
… one of the following: confirmed PIK3CA mutation or amplification, PTEN loss of function, EGFR mutation, cMET activation and/or HER2 overexpression.
EGFR exon 19 deletion / L858RPIK3CA activating mutationAdvanced Solid Tumor
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Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
infigratinibalpelisib FDA EU
Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alter…
PIK3CA activating mutationAdvanced Solid Tumors, Metastatic Solid Tumors
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Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
ceritinib FDA EUAUY922
tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
ALK fusionAnaplastic Lymphoma Kinase (ALK), Non-small Cell Lung Cancer
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PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
AUY922alpelisib FDA EU
gastric tumors carrying PIK3CA mutation or amplification, or HER2-overexpression, or both;
PIK3CA activating mutationStomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein
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Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
ceritinib FDA EU
For non-small cell lung cancer (NSCLC), an ALK translocation must be detected by Fluorescent in situ hybridization (FISH) in ≥15% of tumor cells.
ALK fusionTumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
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A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
ceritinib FDA EU
For NSCLC, an ALK translocation must be detected by FISH in ≥ 15% of tumor cells.
ALK fusionTumors Characterized by Genetic Abnormalities of ALK
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A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
dabrafenib FDA EUtrametinib FDA EUOther approved anti-cancer agent
A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
BRAF V600ECancer
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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
alpelisib FDA EUfulvestrant FDA EU
… Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
PIK3CA activating mutationAdvanced Solid Tumors With an Alteration of the PIK3CA Gene, Estrogen Receptor Positive Breast Cancer
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A Study of BEZ235 in Adult Japanese Patients With Advanced Solid Tumors
Patients whose molecular status proved to meet the criteria (PIK3CA mutation/amplification and/or PTEN mutation and/or low/null PTEN expression) during pre-screening.
PIK3CA activating mutationAdvanced Solid Tumor
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A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
…ically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
FGFR3 alteration (mutation or fusion)Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification, Bladder Cancer With FGFR3 Mutation or Fusion, Advanced Solid Tumors With FGFR1 Amplication
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A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
Eligible patients will have to have tumors carrying molecular alterations of PIK3CA and/or PTEN.
PIK3CA activating mutationBreast Cancer, Advanced Solid Tumors, Cowden Syndrome
No trials match these filters.