Company
Roche
25 active trials that select patients by a biomarker on marked.bio, across 7 biomarkers; 10 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).
inavolisib 9divarasib 6entrectinib 5fulvestrant 4alectinib 4pembrolizumab 3letrozole 3atezolizumab 3palbociclib 2cetuximab 2nivolumab 1sotorasib 1adagrasib 1alpelisib 1durvalumab 1crizotinib 1ribociclib 1giredestrant 1vemurafenib 1cobimetinib 1
Upcoming readouts
Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.
- 2026-11 A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy Phase 3 · PIK3CA activating mutation
- 2026-11 A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) Phase 2 · KRAS G12C, BRAF V600E, ALK fusion, ROS1 fusion, RET fusion or mutation, NTRK1/2/3 fusion
- 2026-12 A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer Phase 3 · PIK3CA activating mutation
- 2027-06 Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Phase 2 · ALK fusion
- 2027-06 Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options Phase 1/2 · ROS1 fusion, NTRK1/2/3 fusion
- 2027-07 A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer Phase 2 · PIK3CA activating mutation
Trials
25 of 99 trials shown
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A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
divarasibpembrolizumabnivolumab
Documentation of the presence of a KRAS G12C mutation
KRAS G12CNon-small Cell Lung Cancer
-
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
divarasibpembrolizumabpemetrexedcarboplatincisplatin
Documentation of the presence of a KRAS G12C mutation
KRAS G12CNon-Small Cell Lung Cancer, KRAS G12C Lung Cancer
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
inavolisib FDA EUCDK4/6iletrozole
…and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
PIK3CA activating mutationBreast Cancer
-
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
divarasibsotorasib FDA EUadagrasib FDA EU
Documentation of the presence of a KRAS G12C mutation
KRAS G12CNon-Small Cell Lung Cancer, KRAS G12C Lung Cancer
-
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
inavolisib FDA EUPhesgoTaxane-based ChemotherapyOptional Endocrine Therapy of Investigator's Choice
Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documen…
PIK3CA activating mutationMetastatic Breast Cancer
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
inavolisib FDA EUfulvestrant FDA EUalpelisib FDA EUBupropionOmeprazolemidazolam
…Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Ther…
PIK3CA activating mutationBreast Cancer
-
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)
alectinib FDA EUentrectinibdurvalumab
…rformed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy…
ALK fusionROS1 fusionNon-Small Cell Lung Cancer
-
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
entrectinib FDA EUcrizotinib FDA EU
… amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.
ROS1 fusionCarcinoma, Non-Small-Cell Lung
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A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
inavolisib FDA EUpalbociclib FDA EUfulvestrant FDA EU
…b + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
PIK3CA activating mutationBreast Cancer
-
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
alectinib FDA EUcisplatinvinorelbinegemcitabinepemetrexedcarboplatin
Documented ALK-positive disease according to an FDA-approved and CE-marked test
ALK fusionCarcinoma, Non-Small-Cell Lung
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To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
inavolisib FDA EUfulvestrant FDA EU
Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation
PIK3CA activating mutationBreast Cancer
-
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
inavolisib FDA EUribociclibletrozolegiredestrant
Confirmed PIK3CA mutation
PIK3CA activating mutationBreast Cancer
-
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
divarasibpembrolizumabcarboplatincisplatinpemetrexed
…ipants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
KRAS G12CNon-Small Cell Lung Cancer
-
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
alectinib FDA EU
Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-…
ALK fusionALK Fusion-positive Solid or CNS Tumors
-
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
alectinibentrectinibvemurafenibcobimetinibpralsetinibatezolizumabSBRTChemotherapydivarasib
…on in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation
KRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionNon-small Cell Lung Cancer
-
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
entrectinib FDA EU
Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions
ROS1 fusionNTRK1/2/3 fusionSolid Tumors, CNS Tumors
-
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
…agnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
ALK fusionBreast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms
-
A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
GDC-7035panitumumabmFOLFOX6FOLFIRImFOLFIRINOXGem-nabP
Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testi…
KRAS G12DColorectal Neoplasms, Pancreatic Ductal Adenocarcinoma
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AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
AQUA07lorlatinib FDA EU
…xcluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC, who have experienced disease progression during or following their most recent sys…
ALK fusionALK Positive Non-small Cell Lung Cancer
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RO7673396
Confirmed presence of the RAS mutation(s)
KRAS G12CKRAS G12DNeoplasms
-
Study of AUBE00 in Patients With Solid Tumors
AUBE00cetuximab
Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)
KRAS G12CKRAS G12DSolid Tumors
-
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
Phase I Arm APhase I Arm B
Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
KRAS G12DSolid Tumor
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A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
inavolisib FDA EUatezolizumab
A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
PIK3CA activating mutationPIK3CA-Mutated Cancers
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A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
divarasibatezolizumabcetuximabbevacizumaberlotinibGDC-1971inavolisib
Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
KRAS G12CNon-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors
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To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
inavolisib FDA EUfulvestrant FDA EUletrozolepalbociclib FDA EUmetformintrastuzumabpertuzumab
Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer
PIK3CA activating mutationBreast Cancer, Solid Tumor
-
An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
vemurafenib FDA EU
BRAF V600 mutation-positive malignancy
BRAF V600ENeoplasms
-
An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
vemurafenib FDA EU
AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemu…
BRAF V600EMalignant Melanoma
-
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
erlotinib FDA EU
Non-small cell lung cancer with an EGFR activating mutation
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
erlotinib FDA EU
Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
-
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
alectinib FDA EUcisplatincarboplatinpemetrexed
Documented ALK fusion
ALK fusionNon-Small Cell Lung Cancer
-
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).
pralsetinib FDAcabozantinibvandetanib
Confirmed RET mutation.
RET fusion or mutationMedullary Thyroid Cancer
-
A Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)
atezolizumabbevacizumabpaclitaxelpemetrexedcarboplatin
…ecimen that is suitable for the determination of PD-L1 status, as well as the presence of EGFR mutations and ALK gene rearrangements, via central testing.
EGFR exon 19 deletion / L858RALK fusionCarcinoma, Non-Small-Cell Lung
-
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
pralsetinib FDAcarboplatincisplatinpemetrexedpembrolizumabgemcitabinepaclitaxelnab-paclitaxel
Participant must have a documented RET-fusion
RET fusion or mutationRET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms
-
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
ipatasertibpaclitaxel
… Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positi…
PIK3CA activating mutationBreast Cancer
-
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
alectinib FDA EUcrizotinib FDA EU
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
ALK fusionRET fusion or mutationNeoplasms
-
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
alectinib FDA EUcrizotinib FDA EU
…age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test.
ALK fusionAnaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
-
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
taselisibfulvestrant FDA EU
A valid cobas PIK3CA mutation result by central testing is required
PIK3CA activating mutationBreast Cancer
-
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
alectinib FDA EUdocetaxelpemetrexed
…age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive.
ALK fusionNon-small Cell Lung Cancer
-
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
alectinib FDA EUcrizotinib FDA EU
…age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
ALK fusionNon-Small Cell Lung Cancer
-
A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation
erlotinib FDA EUonartuzumab
…MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma
vemurafenib FDA EUcobimetinib FDA EU
… in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test
BRAF V600EMalignant Melanoma
-
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
vemurafenib FDA EU
Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according…
BRAF V600EMelanoma
-
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
erlotinib FDA EUChemotherapy
Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer
-
A Study of Vemurafenib in Participants With Metastatic Melanoma
vemurafenib FDA EU
AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test.
BRAF V600EMalignant Melanoma
-
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
vemurafenib FDA EUdacarbazine
positive for BRAF V600E mutation
BRAF V600EMalignant Melanoma
-
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer
inavolisib FDA EUbevacizumabFOLFOXFOLFIRI
…Inavolisib With Bevacizumab Plus Folfox or Folfiri as First Line Therapy in Patients With PIK3CA-Mutated Metastatic Colorectal Cancer
PIK3CA activating mutationColorectal Cancer
-
A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)
…ancer, head and neck cancer and any other tumor type with known high TMB (≥ 13 mut/MB) or MSI-H
MSI-H / dMMRSolid Tumors
-
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
alectinib FDA EU
Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer
ALK fusionNeoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms
-
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung
-
A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
cobimetinib FDA EUatezolizumab FDAvemurafenib FDA EU
…th Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
BRAF V600EMetastatic Melanoma
-
A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer
alectinib FDA EU
…ken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridizati…
ALK fusionCarcinoma, Non-Small-Cell Lung
-
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
pralsetinib FDA
All participants treated at doses \> 120 mg per day must have MTC, or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
RET fusion or mutationRET-altered Non Small Cell Lung Cancer, Medullary Thyroid Cancer, RET-altered Papillary Thyroid Cancer, RET-altered Colon Cancer
-
A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma
cobimetinib FDA EUvemurafenib FDA EU
A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Adva…
BRAF V600EMetastatic Melanoma
-
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
trastuzumabpertuzumaberlotinibvemurafenib FDA EUcobimetinib FDA EUVismodegibalectinibatezolizumab FDA
…esting results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing r…
BRAF V600EALK fusionNeoplasms, Solid Tumors, Biliary Cancer, Salivary Cancer
-
A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
GDC-0810LHRH Agonistpalbociclib
Cohort A only: confirmed estrogen receptor alpha (ESR1) mutation and presence of measurable disease as per RECIST v1.1 or evaluable bone disease
ESR1 mutationBreast Cancer
-
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
alectinib FDA EU
ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test
ALK fusionNon-Small Cell Lung Cancer
-
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment
Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test
ALK fusionNon-Small-Cell Lung Carcinoma
-
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
erlotinib FDA EU
…Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
cetuximab FDA EUvemurafenib FDA EU
Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative the…
BRAF V600EMultiple Myeloma, Neoplasms
-
A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
erlotinib FDA EU
Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
erlotinib FDA EU
Locally advanced or metastatic NSCLC with EGFR mutations
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
erlotinib FDA EU
…atment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
EGFR exon 19 deletion / L858RCarcinoma，Non-Small-Cell Lung
-
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
erlotinib FDA EU
…Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
erlotinib FDA EU
Presence of epidermal growth factor receptor (EGFR) mutations
EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer
-
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
vemurafenib FDA EU
…atic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E, as detected by DNA sequencing of exon 15 performed at a centralized laboratory
BRAF V600EMalignant Melanoma
-
A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases
vemurafenib FDA EU
…gically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
BRAF V600EMalignant Melanoma
-
A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation
vemurafenib FDA EU
Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)
BRAF V600ENeoplasms
-
A Study of RO5185426 in Patients With Metastatic Melanoma
vemurafenib FDA EU
Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
BRAF V600EMalignant Melanoma
-
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
vemurafenib FDA EU
…ic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)
BRAF V600EMalignant Melanoma
-
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
vemurafenib FDA EU
BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
BRAF V600EMalignant Melanoma
-
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tum…
HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer
-
Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer
GDC-1971osimertinib FDA EUcetuximab
Positive for an EGFR exon 19 deletion or exon 21 L858R mutation
EGFR exon 19 deletion / L858RColorectal Cancer, Non-Small Cell Lung Cancer
-
A Study Evaluating the Safety, Pharmacokinetic and Anti-tumor Activity of RO7428731 in Participants With Glioblastoma
RO7428731
…minary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III
EGFR exon 19 deletion / L858RGlioblastoma
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A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
SPYK04
Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RAS mutations)
KRAS G12CKRAS G12DLocally Advanced or Metastatic Solid Tumors
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A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer
…LY, have a deleterious germline or somatic breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation or tumors that are wild-type BRCA but show high levels of loss of heterozygosity (LOH) (t…
BRCA1/2 mutationGynecologic Neoplasms
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A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
itraconazoleRifampinvemurafenib FDA EU
…ears with either unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF
BRAF V600EMetastatic Melanoma, BRAF V600 Mutation Positive
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Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies
vemurafenib FDA EU
Participants with either unresectable or metastatic melanoma positive for the BRAF\^V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, and for wh…
BRAF V600EMalignant Melanoma, Cancer
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A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)
alectinibatezolizumaberlotinib FDA EU
Participants in Stage 2 (Expansion) receiving erlotinib: i) sensitizing mutation in the EGFR gene and ii) consent to collection of tumor tissue samples before, during, and after trea…
EGFR exon 19 deletion / L858RALK fusionNon-Small Cell Lung Cancer
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Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients
cobimetinibOnartuzumabvemurafenib
Patients with a histologically confirmed, KRAS-mutant, Stage IV colorectal adenocarcinoma, or KRAS-mutant metastatic non-small-cell lung carcin…
KRAS G12CKRAS G12DBRAF V600ENeoplasms
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A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS
cobimetinibMEHD7945A
Locally advanced or metastatic solid KRAS-mutant tumors, for which standard therapies do not exist, have proven ineffective or intolerable…
KRAS G12CKRAS G12DNeoplasms
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Study of RXDX-105, Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid Tumors
RXDX-105
Patients with BRAF V600E mutations must be TKI-naïve
BRAF V600ERET fusion or mutationSolid Tumors
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A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
vemurafenib FDA EU
Positive BRAF V600 mutation result determined by a designated laboratory using the Cobas 4800 BRAF V600 Muta…
BRAF V600EMalignant Melanoma
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A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
acenocoumarolvemurafenib FDA EU
Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor…
BRAF V600EMalignant Melanoma, Neoplasms
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A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies
Tizanidinevemurafenib FDA EU
Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, …
BRAF V600EMalignant Melanoma, Neoplasms
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A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
phenprocoumonvemurafenib FDA EU
Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor…
BRAF V600EMalignant Melanoma, Neoplasms
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A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
ketoconazolevemurafenib FDA EU
…ents with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, a…
BRAF V600EMalignant Melanoma, Neoplasms
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A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
Rifampinvemurafenib FDA EU
…ants with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAF V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, a…
BRAF V600EMalignant Melanoma, Neoplasms
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A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
vemurafenib FDA EU
Histologically confirmed BRAF V600 mutation-positive advanced solid malignancy that is metastatic or unresectable and for wh…
BRAF V600ENeoplasms
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BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
vemurafenib FDA EU
Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation Test)
BRAF V600EMalignant Melanoma
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A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Digoxinvemurafenib FDA EU
…ents with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, a…
BRAF V600EMalignant Melanoma, Neoplasms
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A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma
atezolizumab FDAcobimetinib FDA EUvemurafenib FDA EU
…ologic or cytologic documentation of metastatic or Stage IIIc unresectable melanoma, with BRAFV600 mutation as assessed by BRAFV600 Mutation Test.
BRAF V600EMalignant Melanoma
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A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
vemurafenib FDA EU
Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
BRAF V600EMalignant Melanoma
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A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
cobimetinib FDA EUvemurafenib FDA EU
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
BRAF V600EMalignant Melanoma
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A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
fulvestrant FDA EUtaselisibletrozolemidazolam
Phase I (Cohort X): Participants with PIK3CA-mutant tumors and measurable disease per RECIST v1.1
PIK3CA activating mutationSolid Cancers, Non-Hodgkin's Lymphoma
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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors
GDC-0623
… cohort must have had no more than four prior systemic therapies for cancer and must have KRAS mutant CRC (Stage II A and B), pancreatic cancer (Stage IIC, or KRAS mutant NSCLC \[Stage IID\])
KRAS G12CKRAS G12DSolid Cancers
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A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
vemurafenib FDA EU
positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)
BRAF V600EMalignant Melanoma
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A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
vemurafenib FDA EU
Positive BRAF V600E mutation result (by Roche CoDx test)
BRAF V600EMalignant Melanoma
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A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors
RO5212054
A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors
BRAF V600ENeoplasms
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A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.
RO5083945
histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer (Part 2);
KRAS G12CKRAS G12DNeoplasms
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