14 results
To demonstrate superiority with regard to overall survival (OS) of avelumab versus docetaxel in subjects with programmed death ligand 1 (PD-L1) positive (+; as determined by a companion diagnostic test under development), non-small cell lung cancer…
The primary objective of this study is to assess the overall safety and tolerability of subcutaneous (SC) trastuzumab using SID (Singel Injection Device) in HER2-positive eBC (early Breast Cancer) patients self-administered at home under supervision…
Primary Objective* To demonstrate that avelumab given alone or in combination with Pegylatedliposomal doxorubicin (PLD) is superior to PLD alone in prolonging Overall Survival(OS) in patients with platinum -resistant/platinum-refractory ovarian…
Feasibility
The purpose of this study is to evaluate the safety and preliminary efficacy of avelumab in combination with M9241in subjects with metastatic or locally advanced unresectable solid tumors. This dose escalation study will establish a safe dose of…
The primary objective of the Phase I portion of the study is the following:* To estimate the maximum tolerated dosing schedule for venetoclax given in combination with R-CHOP or G-CHOP to patients with B-cell NHL, either previously untreated or…
Co Primary Objectives:1. To demonstrate that avelumab in combination with platinum based chemotherapy followed by avelumab maintenance (Arm C) is superior to platinum based chemotherapy alone followed by observation (Arm A) in prolonging progression…
Primary Objective:• Safety and tolerability of VXM01 in combination with avelumabSecondary Objectives:• Efficacy of VXM01 in combination with avelumab by assessment of tumor objective response rate (ORR) per Immunotherapy Response Assessment in…
The aim of the study is to develop PD-L1 PET/CT imaging in patients with NSCLC to noninvasively image PD-L1 expression in tumors and to determine the correlation with response to avelumab. For this purpose, two studies will be carried out to1:…
Primary Objective:* To evaluate ORR of avelumab in combination with talazoparib, in patients with locally advanced or metastatic solid tumors harboring BRCA1, BRCA2 or ATM defect.Secondary Objective:* To assess the overall safety and tolerability of…
The primary objective is to demonstrate the efficacy in subjects with R/R T-PLL treated with venetoclax plus ibrutinib.
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
The primary objective of this study is to evaluate the efficacy of venetoclax monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL).
Primary Objectives- Cohort 1 Part 1: To determine the KRT-232 recommended phase 2 dose (RP2D)- Cohort 1 Part 2: To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PD-L1 immunotherapy- Cohort 2…