31 results
Zie pagina 39-40 van het protocol MO22923 versie 2, 26 Mei 2011
The primary objective of the phase I part of the study is to determine the recommended phase II dose of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer. The secondary objectives the phase I…
To demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients.
Primary objective· • To investigate the safety and tolerability and establish either the dose of KU-0059436 which causes inhibition of PARP in combination with an active dose of carboplatin or the maximum tolerated dose (MTD) of KU-0059436 in…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
Primary: • Evaluate the safety of TIL, alone or with IFNα, in patients with recurrent platinum sensitive EOC during standard chemotherapy (carboplatin and paclitaxel).Secondary: • Evaluate signs of activity and underlying mechanisms (response rate,…
Primary: • To investigate whether adjuvant atezolizumab treatment after standard, concurrent chemo-radiotherapy improves overall survival (OS) compared with no treatment after standard, concurrent chemo-radiotherapy in limited disease SCLC patients.…
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…
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 (…
The purpose of this study is to evaluate the safety, pharmacokinetics, and activity of GDC-6036 combined with other anti-cancer therapies in patients with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC) that harbors a…
• To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer
Dose escalation: To establish the MTD and RP2D of tisotumab vedotin in combination in subjects with cervical cancer Dose expansion: Evaluate the antitumor activity of tisotumab vedotin monotherapy and incombination in subjects with cervical cancer
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 evaluate efficacy of image-guided de-escalating chemotherapy in the presence of dual HER2-blockade with Herceptin® and pertuzumab in HER2-positive breast cancer, as measured by three-year event-free survival.Secondary objectives• To evaluate 3-…
This study is designed to assess the efficacy and safety of pembrolizumab monotherapy compared with SoC platinum doublet chemotherapy for first-line treatment of participants with dMMR advanced or recurrent EC. The primary objectives are to compare…
This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after surgery, will be investigated in patients with resectable Stages II and III NSCLC. The efficacy of durvalumab will…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
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 OBJECTIVESThe primary objective of MAKEI V is to assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle) (AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant GCT (MGCT) of…