21 results
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Primary objective: Response to trametinib treatment defined as a tumor volume decreases from baseline of >=20%, monitored by using volumetric MRI analysis. Secondary objectives are: patient reported outcomes of pain and disability and quality…
Part A - CX-2009 Monotherapy: Every 21-Day Dosing RegimenThe primary objective of Part A is to determine the safety profile of CX-2009, the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the dose-limiting toxicities(DLTs) of CX-…
Part A:* To obtain evidence of antitumor effect of CX-072 in combination with ipilimumab in subjects withsolid tumors based on the objective response rate (ORR) as defined by the Response EvaluationCriteria in Solid Tumours (RECIST) v1.1Part B:* To…
This drug-drug interaction (DDI) study is being conducted to determine if there is a pharmacokinetic (PK) interaction between trametinib and the components of combination oral contraceptives (OCs), norethindrone (NE) and ethinyl estradiol (EE).…
The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…
PRIMARY- Phase Ib: To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 regimen (RP2R) of ribociclib and trametinib in patients with solid tumors- Phase II: To assess overall response rate (ORR) with the combination of…
Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…
Primary objectives Phase I: To determine the recommended phase 2 dose (RP2D) of the lapatinib-trametinib combination in patients with KRASm NSCLC Phase II: To determine the progression free survival of the lapatinib-trametinib combination compared…
The main objective of this study is to study the feasibility and efficacy of neo-adjuvant treatment with BRAF/MEK inhibition to increase R0 rate of the tumor resection.
This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…
Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…
Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term effect of treatment with dabrafenib, trametinib or the combination on general health, growth and development.To…
This is an open-label, multi-center, roll-over study designed to provide continued access to subjects who have previously participated in a dabrafenib and/or trametinib parent study and who have fulfilled the requirements for the primary objective,…
PrimaryPhase I: To assess the safety and tolerability of the investigational agents and define the MTD/RP2D(s)Phase II: To evaluate the activity of new drugs in T-ALL/T-LBL patients harboring specific alterations linked to mechanism of action of…
Primary Objectives• To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with an advanced solid tumor, multiple myeloma or non-Hodgkin lymphoma that harbours a genomic…
* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…