34 results
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 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…
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 (…
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…
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…
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 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…
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…
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
This Phase Ia/Ib study will evaluate the safety, pharmacokinetics, immunogenicity (as applicable for study biotherapeutics), preliminary activity, and biomarkers of GDC-6036 as a single agent (Arm A) and in combination with other anti-cancer…
This study will evaluate the efficacy and safety of consolidation maintenance treatment consisting of atezolizumab and tiragolumab compared with durvalumab in patients with locally advanced, unresectable Stage III NSCLC who have received at least…
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…
The main objective of the trial is to determine the pathological response rate in cohort 1 and the radiological response rates in cohort 2, 3 and 4. The secondary objectives of the trial are the safety of atezolizumab and tiragolumab, the response…
The evaluation of R-IrAE's after ICI therapy, specifically incidence, treament of R-IrAE's, response to said treatment, baseline and follow-up serology (general and symptom specific) to be combined with quality of life assessment and…
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.…
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…
To test whether the proportion of patients in remission during the last 6 months of follow up is higher for a T2T strategy compared to a T2S stop strategy.
To determine the real-world pharmacokinetics of ICIs.
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…