72 results
Herewith, we present a research protocol that allows us to examine feasibility and safety of checkpoint blockade neoadjuvant to standard of care (SOC) in a patient population in need for improved clinical outcome and in tumors likely to respond to…
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…
Primary objective: To determine safety, feasibility, and the immune-activating capacity of short-term combined neo-adjuvant and adjuvant ipilimumab + nivolumab.Secondary objectives: To determine relapse free survival (RFS), any late adverse events,…
The objective of this study is to determine how well two different doses of ipilimumab work in patients with prostate cancer who are no longer responding to hormone therapy (castration resistant), and whom have the best radiographic progression-…
To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab (MDX-010) vs. dacarbazine with placebo.
The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…
To compare the overall survival of ipilimumab monotherapy at doses of 3 mg/kg versus 10 mg/kg in subjects with previously treated or untreated unresectable Stage III or Stage IV melanoma
Primary Objective: To compare Overall Survival (OS) of subjects with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and…
The objective of this study is to compare the overall survival of patients with castration resistant prostate cancer who have progressed after receiving docetaxel treatment, when they are treated with bone directed radiotherapy plus Ipilimumab…
The aim of the study is to measure whether there is a difference in LDL cholesterol levels or the 24 hour ambulatory blood pressure in individuals at high risk of cardiovascular disease when the polypill is taken in the morning compared with the…
Dose Escalation PhasePrimary - Evaluate the safety and tolerability of epcoritamab in combination with other agents Secondary- Characterize the PK properties of epcoritamab- To evaluate pharmacodynamic markers linked to efficacy and mechanism of…
Main objective Monotherapy Cohorts (R/R CLL):• Identify the RP2D and the MTD of epcoritamab• Evaluate the safety and tolerability of epcoritamabExpansion Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]):• Assess the preliminary efficacy of…
To determine the real-world pharmacokinetics of ICIs.
OpACIN-neo:Primary objectives: - To compare safety (immune related adverse events during the first 12 weeks) of three different neo-adjuvant combination schemes of ipilimumab + nivolumab - To compare radiological and pathologic response rates at…
The primary objective is to investigate the rate of pathological responses following different neoadjuvant immunotherapy combinations in high-risk non-metastatic clear cell RCC in an adaptive trial design. And to study the safety and feasibility of…
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong progression-free survival (PFS) compared with 6 cycles of standard R-…
The primary objective of this study is to evaluate the rate of ongoing response at 12 months after start of treatment in patients with irresectable stage III or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early…
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:…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
Primary Objectives:• To compare Blinded Independent Committee for Radiology (BICR)-assessed objective response rate (ORR) in participants of tissue Tumor Mutational Burden-High (tTMB-H) treated with nivolumab combined with ipilimumab • To compare…