- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Metastases: IMspire150: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma (clinicaltrials.gov) - Feb 22, 2018 P3, N=500, Recruiting, Trial primary completion date: Oct 2020 --> May 2017 Trial primary completion date: Jul 2019 --> Oct 2019 | Trial completion date: Jul 2019 --> Jul 2023
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche
Enrollment closed, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: GEM-01-15: Clinical Trial to Evaluate the Efficacy of Vemurafenib in Combination With Cobimetinib (Continuous and Intermittent) in BRAFV600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov) - Feb 19, 2018 P2, N=70, Active, not recruiting, Trial primary completion date: Jul 2019 --> Oct 2019 | Trial completion date: Jul 2019 --> Jul 2023 Recruiting --> Active, not recruiting | N=116 --> 70 | Trial primary completion date: Dec 2018 --> Sep 2019 | Trial completion date: Dec 2018 --> Sep 2019 | Initiation date: Jun 2015 --> Jun 2015
- |||||||||| ONCase (recombinant methionine α, γ-lyase) / AntiCancer, Shionogi, Nantong Jinghua
Journal: Recombinant methioninase (rMETase) is an effective therapeutic for BRAF-V600E-negative as well as -positive melanoma in patient-derived orthotopic xenograft (PDOX) mouse models. (Pubmed Central) - Feb 11, 2018 Melanoma patients with the BRAF-V600E mutation have been treated with the drug vemurafenib (VEM) which targets this mutation...Forty BRAF-V600E-negative melanoma PDOX mouse models were randomized into four groups of 10 mice each: untreated control (n = 10); temozolomide (TEM) (25 mg/kg, p.o., 14 consecutive days, n = 10); rMETase (100 units, i.p., 14 consecutive days, n = 10); TEM + rMETase (TEM: 25 mg/kg, p.o., rMETase: 100 units, i.p., 14 consecutive days, n = 10)...The present study shows that TEM combined with rMETase is effective for BRAF-V600E-negative melanoma PDOX similar to the BRAF-V600E-positive mutation melanoma. These results suggest rMETase in combination with first-line chemotherapy can be highly effective in both BRAF-V600E-negative as well as BRAF-V600E-positive melanoma and has clinical potential for this recalcitrant disease.
- |||||||||| Zelboraf (vemurafenib) / Roche
Trial primary completion date: Safety Study of PLX4032 in Patients With Solid Tumors (clinicaltrials.gov) - Dec 30, 2017 P1, N=75, Active, not recruiting, Trial primary completion date: Feb 2018 --> Feb 2019 Trial primary completion date: Jun 2014 --> Aug 2015
- |||||||||| sonolisib (PX 866) / Pfizer
Enrollment change, Metastases: Study of PX-866 and Vemurafenib in Patients With Advanced Melanoma (clinicaltrials.gov) - Dec 29, 2017 P1/2, N=24, Terminated, VEM combined with S. typhimurium A1-R was significantly more effective than VEM alone or VEM combined with COB (p = 0.0216) which is currently first line therapy for advanced melanoma with BRAF-V600E mutation. N=146 --> 24
- |||||||||| Zelboraf (vemurafenib) / Roche
Journal: Co-occurring Genomic Alterations and Association With Progression-Free Survival in BRAFV600-Mutated Nonmelanoma Tumors. (Pubmed Central) - Nov 30, 2017 BRAF inhibitor vemurafenib was recently found to demonstrate activity across various BRAF-mutated nonmelanoma cancer types...PI3K-mTOR pathway aberrations were associated with a statistically significant reduction in progression-free survival (HR = 15.0, 95% CI = 3.6 to 63.0, P < .001) and overall survival (HR = 19.2, 95% CI = 3.7 to 100.0, P < .001). This suggests that co-occurring genomic alterations may predict response and resistance to BRAF inhibitor therapy and identify subgroups of BRAF-mutated nonmelanomas cancers.
- |||||||||| Cotellic (cobimetinib) / Exelixis, Roche, Zelboraf (vemurafenib) / Roche, Tecentriq (atezolizumab) / Roche
Biomarker, Trial primary completion date, PD(L)-1 Biomarker: Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC (clinicaltrials.gov) - Oct 27, 2017 P2, N=110, Recruiting, Cancer Discov; 6(12); 1352-65. Trial primary completion date: Apr 2017 --> Apr 2019
- |||||||||| Erbitux (cetuximab) / Eli Lilly, Zelboraf (vemurafenib) / Roche
Enrollment closed, Enrollment change, Combination therapy, Surgery, Metastases: Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery (clinicaltrials.gov) - Sep 21, 2017 P1, N=47, Active, not recruiting, Trial primary completion date: Aug 2017 --> Aug 2018 Recruiting --> Active, not recruiting | N=35 --> 47
- |||||||||| buparlisib (AN2025) / Novartis, Adlai Nortye, Zelboraf (vemurafenib) / Roche
Trial completion, Enrollment change, Trial primary completion date, Metastases: BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma (clinicaltrials.gov) - Sep 18, 2017 P1/2, N=8, Completed, Recruiting --> Active, not recruiting | N=35 --> 47 Recruiting --> Completed | N=46 --> 8 | Trial primary completion date: Jun 2014 --> Dec 2013
- |||||||||| Biomarker, Enrollment change, Trial primary completion date, MSi-H Biomarker, PD(L)-1 Biomarker: MODUL: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - Sep 1, 2017
P2, N=1400, Recruiting, Recruiting --> Completed | N=46 --> 8 | Trial primary completion date: Jun 2014 --> Dec 2013 N=610 --> 1400 | Trial primary completion date: Feb 2019 --> Oct 2020
- |||||||||| Zelboraf (vemurafenib) / Roche
Trial completion, Enrollment change: Safety Study of PLX4032 in Patients With Solid Tumors (clinicaltrials.gov) - Aug 22, 2017 P1, N=109, Completed, N=610 --> 1400 | Trial primary completion date: Feb 2019 --> Oct 2020 Active, not recruiting --> Completed | N=75 --> 109
- |||||||||| Biomarker, Enrollment open, BRCA Biomarker, PARP Biomarker, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Jul 28, 2017
P2, N=1500, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
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