34 results
Primary:To assess the safety and tolerability of Firdapse after single and multiple doses Secondary:Part 1 only: To determine the dose-related PK profile of single, escalating doses of Firdapse;Part 2 only: To assess the steady-state plasma PK and…
The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin or cisplatin compared with placebo plus gemcitabine/carboplatin or cisplatin on the basis of the following endpoints:- Co-primary…
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
Primary Efficacy ObjectivesUnless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + paclitaxel + bevacizumab (Arm B) versus carboplatin + paclitaxel + bevacizumab (…
The primary objectives of this study are:* To describe the safety and tolerability of cergutuzumab amunaleukin in combination with atezolizumab* To determine the MTD, if achieved, of cergutuzumab amunaleukin in combination with atezolizumab* To…
Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and…
This study will evaluate the efficacy, safety, and pharmacokinetics of atezo + cobi + vem compared with placebo plus cobimetinib plus vemurafenib (placebo+ cobi + vem) in patients with previously untreated, BRAFV600 mutation*positive, metastatic or…
The primary and secondary efficacy objectives analysis will be performed in patients who are PD-L1 positive (defined as IHC 2 and IHC 3 on the basis of tumor PD-L1 expression) and when appropriate may be performed in different patient subpopulations…
To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review
Primary ObjectiveTo determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for: infusion related reaction during…
The primary objective of the study is to assess the efficacy and safety of 3 different treatment arms (bevacizumab alone, atezolizumab-bevacizumab combination with acetylsalicylic acid and atezolizumab-bevacizumab combination with placebo) in…
The primary objective is efficacy of atezolizumab in advanced penile cancer patients measured by progression-free survival.
This study will evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in patients with previously untreated locally advanced, unresectable or metastatic PD-L1 selected NSCLC, with no EGFR mutation…
This study will evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patients with solid tumors.
Modified objectives after implementation of protocol amendment February 2017: Primary: 1. Validate the BRCA-like test* in predicting differential PFS with first line alkylating and platinum agents when compared to paclitaxel in TNBC Secondary: 1.…
This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone (Atezo + Tira) or in combination with platinum-based chemotherapy (Atezo + Tira + Chemo) as neoadjuvant treatment for patients with previously…
To determine the real-world pharmacokinetics of ICIs.
Primary objective:• To evaluate the 2-year disease free survival (DFS)Secondary objectives:• To evaluate toxicity and asses the relation of adverse events in time to recovery of the T-cell repertoire• To evaluate the 2-year overall survival (OS)• To…
This study will evaluate the long-term safety and efficacy of atezolizumab in patients with locally advanced or metastatic NSCLC who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy…
The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib, and ABBV-599 versus placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses…