66 results
Main Objective:Phase II part: Efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU.Phase III part: Efficacy of cabazitaxel compared…
To investigate the influence of concomitant enzalutamide on the pharmacokinetics of cabazitaxel.
Primary objective: To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patientsSecondary objectives:• To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett*s correction), and QTcN (population…
The main objective is to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient antitumor activity (as measured by progression free survival at 12 weeks) in pre-treated patients with metastatic or inoperable locally…
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…
Primary ObjectiveTo evaluate the preliminary safety and tolerability and the preliminary efficacy of cobimetinib administered as single agent (Arm A), cobimetinib + venetoclax (Arm B), and cobimetinib + venetoclax + atezolizumab (Arm C)Secondary…
The primary objective of this study is to explore the PSA response rate to cabazitaxel in mCRPC patients who have progressed to docetaxel and to correlate the PSA response to AR-V7 expression in CTCs. Exploratory objectives include documenting the…
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…
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…
To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
The main objective is to determine whether cabazitaxel demonstrates sufficient antitumor activity (as measured by progression free survival at 12 weeks) in pre-treated patients with metastatic or inoperable locally advanced DD liposarcoma to justify…
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 objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…
The primary efficacy objective for this study is to evaluate the efficacy of MPDL3280Ain patients with PD-L1*positive locally advanced or metastatic NSCLC, as measuredby investigator-assessed ORR according to modified RECIST.SECONDARY OBJECTIVESThe…
For the primary and secondary efficacy objectives, analyses will be performed in patients in different patient subpopulations according to programmed death*ligand 1 (PD-L1) expression in tumor tissue as evaluated by immunohistochemistry (IHC). The…
RO7009789 and atezolizumab are experimental drugs that are being investigated by F. Hoffmann La Roche Ltd for the treatment of locally advanced and / or metastatic solid tumors.
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 objective of this study is to explore the PSA response to cabazitaxel in mCRPC patients who have progressed to docetaxel and have detectable AR-V7 expression in CTCs. Exploratory objectives include describing the toxicity of cabazitaxel…
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
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…