21 results
Primary objectives:(1) To determine the safety and tolerability of pembrolizumab. (2) To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (…
Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…
Protocol version Amendment 1, 31-Jul-2015, paragraph 2.1, page 28:Primary objective:The primary objective is to assess the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.Secondary objectives:* Evaluation of…
Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…
Phase 1b Primary Objective: 1. To establish the initial safety and determine a recommended Phase 2 dose (RP2D) of vofatamab in combination with pembrolizumabPhase 2 Primary Objectives: 1. To evaluate the safety and tolerability of vofatamab plus…
Primary objective: To evaluate the safety and tolerability of GSK1795091 when administered in combination with either GSK3174998, GSK3359609, orpembrolizumab.Secondary objectives: * To evaluate the antitumor activity of GSK1795091 when administered…
The primary objective is to assess the long-term safety and tolerability of tirasemtiv, inpatients with ALS
1. To evaluate the progression-free-survival (PFS) in patients with ipilimumab refractory advanced MEL receiving either MK-3475 or chemotherapy.2. To evaluate the overall survival (OS) in patients with ipilimumab refractory advanced MEL receiving…
Main objective:English To determine the antitumor activity of SAR444245 in combination with other anticancer therapiesSecondary objectives: English - To assess the safety of SAR444245 when combined with other anticancer therapies- To assess other…
Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…
Based on the success of the pilot feasibility study, we propose a follow-up efficacy study to explore neo-adjuvant ICB therapy as potential alternative for SoC adjuvant radio(chemo)therapy in MMRd UC.
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…
The primary efficacy objective of this trial is to evaluate the anti-tumor activity of pembrolizumab in subjects with any of a *basket* of rare malignancies (biomarker unselected and biomarker selected). ORR will be used as the primary endpoint per…
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
To identify potential biomarkers for early identification of clinical benefit during pembrolizumab treatment in patients with advanced urothelial cancer. To identify potential mechanisms of primary and acquired resistance to pembrolizumab.To assess…
Primary/dualco-primary. To prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (lobectomy/pneumonectomy) with or without standard adjuvant chemotherapy for stage IB (T >= 4 cm) -II-IIIA…
The primary objective of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progressionfree survival (PFS) (by independent imaging…