119 results
The objectives of the Phase 1 dose escalation are:Primary Objectives:* To establish the Maximum Tolerated Dose (MTD) and to establish the Recommended Phase 2 Dose (RPTD) for veliparib in combination withcarboplatin and etoposide.* To evaluate the…
The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…
The primary objective of the study is to determine the mean prediction error (MPE) and mean absolute prediction error (MAPE) of the area under the plasma concentration-time curve (AUC) of carboplatin after adjusted dosing for high BMI (BMI >…
•To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG) versus treatment of physician*s choice (TPC)Secondary Objectives:•To compare overall survival (OS) between the 2…
Primary objective:- Investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early stage vulvar cancer patients with a macrometastasis (>2mm) and/or extracapsular extension in the sentinel lymph nodeSecondary…
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.…
• To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer
Primary Objectives1) To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) in first line recurrent / metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects, treated…
Primary:To determine the safety, tolerability, MTD (maximum tolerated dose) or the MAD (maximum administered dose) of GSK3359609 in combination with pembrolizumab or chemotherapy with(out) pembrolizumab. Secondary:To determine the recommended dose…
To compare the overall survival of patients with relapsed or refractory GCT treated with conventional-dose chemotherapy using the TIP regimen (CDCT) with patients treated with high-dose chemotherapy (HDCT) plus ASCT using the TI-CE regimen as…
This phase II/III controlled multicenter trial will investigate the ability of individualized chemotherapy to improve the objective response rate of *triple-negative* breast cancer (estrogen receptor and progesterone receptor-negative, no HER2…
Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment regimens for Intermediate risk HB (Group C)-To compare different post induction treatment regimens for High Risk HB (…
Primary Objective:- To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG) and pembrolizumab versus treatment of physician*s choice (TPC) and pembrolizumab. Secondary…
1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response rate of the pembrolizumab combination therapy. PSA response is defined as a reduction in the PSA level of 50% or…
Primary objective: To assess the efficacy of T-DXd relative to platinum with pemetrexed plus pembrolizumab by assessment of PFS by BICR in participants with unresectable, locally advanced, or metastatic NSCLC harboring HER2 exon 19 or 20 mutations.
Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…
The study objectives and endpoints described below will be evaluated for the following treatment regimens:• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance• Arm B: Nivolumab + CCRT followed by nivolumab maintenance• Arm C:…
PRIMARY OBJECTIVES*Rx-induction: Comparison of the 3 year EFS rate of 2 induction regimens, GPOH and RAPID COJEC, in patients with high-risk neuroblastoma.*Rx-HDC: Comparison of the 3 year EFS rate from randomization of single HDC with Bu-Mel versus…
Possibly, outcomes of treatment of irresectable squamous cell carcinoma of the esophagus can be improved by adding bintrafusp alfa to treatment with definitive chemoradiotherapy. As a first step we aim to know whether the addition of bintrafusp alfa…
This study will investigates the effect of high dose alkylating chemotherapy compared to standard dose chemotherapy as part of a multimodality approach in patients with oligometastatic HRD positive and/or BRCA1/2 related breast cancer.