120 results
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…
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…
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…
The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab in patients with locally advanced or…
RO5479599 is an experimental drug under investigation by F. Hoffmann-La Roche for the treatment of solid tumors with a HER3 over-expressed, in this study focused on patients with advanced / metastatic non-small cell lung cancer (NSCLC) of squamous…
Primary Objective: To compare overall survival (OS) of subjects randomized to ipilimumab in addition toplatinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum andetoposide (Arm B) in subjects with newly…
The goal of this study is to determine whether radiosensitization with carboplatin or the addition of Isotretinoin to maintenance therapy improves cure rates for children with other than average risk medulloblastoma/PNET.
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…
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…
Primary Objectivea) Phase I (Safety Run-in) The primary objective of the Phase I Safety Run-in part is to investigate the safety of IO102 in combination with either pembrolizumab alone or pembrolizumab and chemotherapy (carboplatin and pemetrexed)…
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,…
This study is designed to assess the efficacy of pralsetinib as compared to Investigator*s choice platinum-based chemotherapy regimen for patients with metastatic NSCLC harboring an oncogenic RET fusion and who have not received prior systemic…
Primary Objective• To assess the effect of ALX148 + pembrolizumab + 5FU + platinum on 12-month overall survival (OS) rate and objective response rate (ORR)in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated…
The two main objectives of the study are:* To assess the efficacy of ADT in treatment naïve patients with recurrent and/or metastatic, androgen receptor (AR) expressing, SGCs. The primary measure of efficacy is Progression-Free Survival (PFS).* To…
Given the limited effectiveness of available EGFR TKIs in patients with NSCLC with EGFR exon 20 insertion mutations, this subset patient population is routinely treated with chemotherapy, similar to patients with no driver mutations (ie, WT EGFR).…
The primary objective of this study is to determine the accuracy of the application of stereotactic navigation combined with 3D MRI topography during oncologic resection for primary locally advanced rectal cancer in which the tumor is grown in or…
Primary Objective• To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A (vs Arm B participantsSecondary Objectives• To compare the overall survival (OS) in Arm A vs Arm B participants• To assess the…
The primary objective of this study is to determine the immune-activating capacity of treatment with pembrolizumab and carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian cancer as measured by the alteration in magnitude…
Overall program:The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving the staging and the standard of care and to improve our understanding of the underlying biology. The program will evaluate…
Primary Objective:- to assess the effect of chemotherapy given concurrently with pembrolizumab on overall response rate (ORR) in NSCLC patients with high PD-L1 and high tumor burden Secondary Objectives: - to examine the effect of chemotherapy given…