Molecular Profile Detail

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
NRAS Q61X melanoma sensitive MEK inhibitor (Pan) MEK1 Inhibitor MEK2 Inhibitor Binimetinib + Ribociclib Phase II Actionable In a Phase I/II trial, Kisqali (ribociclib) and Mektovi (binimetinib) combination treatment was well-tolerated and resulted in an overall response rate (ORR) of 19.5% (8/41, all PR), a disease control rate of 70.7% (29/41), a median duration of response of 10.3 months, median progression-free survival of 3.7 months, an overall survival (OS) of 11.3 months in patients with melanoma harboring NRAS mutations, and an ORR of 22.9% (16/70) in patients harboring NRAS Q61X (PMID: 35294522; NCT01781572). 35294522
NRAS Q61X myelodysplastic syndrome not applicable N/A Guideline Prognostic NRAS Q61X is associated with a poor prognosis in patients with myelodysplastic syndrome (NCCN.org). detail...
NRAS Q61X colorectal cancer resistant Panitumumab FDA contraindicated Actionable Vectibix (panitumumab) treatment of colorectal cancer patients with NRAS exon 3, codon 61 mutations is contraindicated (FDA.gov). detail...
NRAS Q61X colorectal cancer resistant Cetuximab FDA contraindicated Actionable Erbitux (cetuximab) treatment of colorectal cancer patients with NRAS exon 3, codon 61 mutations is contraindicated (FDA.gov). detail...
NRAS Q61X colorectal cancer unknown MEK inhibitor (Pan) MEK1 Inhibitor MEK2 Inhibitor Binimetinib Phase II Actionable In a Phase II trial (MATCH), Mektovi (binimetinib) treatment did not demonstrate promising efficacy in patients with advanced solid tumors harboring NRAS mutations at codon 12 (n=17), 13 (n=8), or 61 (n=22), however, colorectal cancer patients harboring NRAS Q61 mutations (n=8) achieved longer overall survival (HR 0.34, p=0.03) and progression-free survival (HR 0.23, p=0.007) compared to those harboring mutations at G12 or G13 (n=16) (PMID: 33637626; NCT02465060). 33637626
NRAS Q61X Advanced Solid Tumor unknown MEK inhibitor (Pan) MEK1 Inhibitor MEK2 Inhibitor Binimetinib Phase II Actionable In a Phase II trial (MATCH), Mektovi (binimetinib) therapy led to a nonpromising objective response rate of 2.1% (1/47) in patients (pts) with advanced solid tumors harboring NRAS G12/13 or Q61 mutations, Q61-mutant pts achieved longer overall survival (13.1 vs 5.5 mo, p=0.04) and progression-free survival (5.8 vs 1.8 mo, p=0.006) compared to G12/13-mutant pts examining all tumor types, but not when colorectal caner was excluded (HR 0.84, p=0.70; HR 0.67, p=0.4, respectively) (PMID: 33637626; NCT02465060). 33637626
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01907815 Phase II Trametinib + Uprosertib Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia Terminated USA 0
NCT01910610 Phase III Cetuximab Irinotecan + Panitumumab Panitumumab Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Cetuximab + Irinotecan Cetuximab + Fluorouracil + Irinotecan + Leucovorin Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer (STRATEGIC-1) Recruiting FRA 2
NCT03580382 Phase Ib/II CDX-3379 + Trametinib Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma Terminated USA 0
NCT02296112 Phase II Trametinib Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations Completed USA 0
NCT03365882 Phase II Cetuximab + Irinotecan Pertuzumab + Trastuzumab S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Active, not recruiting USA 1
NCT01740648 Phase I Fluorouracil + Trametinib Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer Active, not recruiting USA 0
NCT03992456 Phase II Panitumumab Regorafenib Trifluridine-tipiracil hydrochloride Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer Recruiting USA 0
NCT02049801 Phase I Binimetinib + Cytarabine + Idarubicin MEK Inhibitor MEK162, Idarubicin, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Terminated USA 0
NCT03442569 Phase II Ipilimumab + Nivolumab + Panitumumab PhII Trial Panitumumab, Nivolumab, Ipilimumab in Kras/Nras/BRAF Wild-type MSS Refractory mCRC Active, not recruiting USA 0
NCT03446157 Phase II Cetuximab + Palbociclib Palbociclib and Cetuximab in Metastatic Colorectal Cancer Recruiting USA 0
NCT03981614 Phase II Trifluridine-tipiracil hydrochloride Binimetinib + Palbociclib Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Active, not recruiting USA 0
NCT02465060 Phase II Erdafitinib Trametinib Crizotinib Sapanisertib AZD4547 Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting USA 2
NCT03592641 Phase II Savolitinib Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer Active, not recruiting USA 0
NCT04513951 Phase II Avelumab + Cetuximab + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients (AVETRIC) Active, not recruiting ITA 0
NCT01763164 Phase III Dacarbazine Binimetinib Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 19
NCT02906059 Phase I Adavosertib + Irinotecan Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer Completed USA 0
NCT04787341 Phase II Regorafenib Panitumumab PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence (PARERE) Recruiting ITA 0
NCT04528836 Phase I IACS-13909 First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors Recruiting USA 0