34 results
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,…
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 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:…
Primary objective • To compare the event-free survival (EFS) of neoadjuvant ipilimumab + nivolumab (followed by adjuvant nivolumab or dabrafenib + trametinib in patients not achieving a pathologic response) versus standard adjuvant nivolumab.
Primary Objectives - To compare Overall Survival (OS) and Progression free survival (PFS) of nivolumab monotherapy to ipilimumab monotherapy and that of nivolumab combined with ipilimumab to ipilimumab monotherapy in subjects with previously…
In this randomized controlled phase III study we will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression free survival when randomly compared…
Primary Objective: To determine the safety and feasibility of pre-operative immunotherapy in CRC. Additional Primary Objective for the expanded the MSI cohort: To assess efficacy of neoadjuvant ipilimumab plus nivolumab in terms of disease-free…
To evaluate the safety and efficacy of the combination of RFA and Ipilimumab in patients with unresectable, pathologically confirmed hepatic metastases of uveal melanoma.
Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…
The study will look at patients with chemotherapy-naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). The research aims to compare a new drug called nivolumab OR nivolumab with ipilimumab (another cancer drug) OR nivolumab combined with…
Primary objective:• To assess the safety and feasibility of adding ipilimumab-nivolumab to a CRT induction protocol• To assess the efficacy of adding ipilimumab-nivolumab to CRT on the likelihood of a pCR and MPRSecondary objectives: • Local and…
Primary objective:To evaluate the efficacy of nivolumab in combination with ipilimumab in molecular pre-selected patients with metastatic castration-resistant prostate cancer. Susceptible patients are selected for MMRd/high mutational burden/tandem…
Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized participants. - To compare EFS of neoadjuvant nivolumab/BMS-986205 +GC followed by continued nivolumab/BMS-986205 after…
Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…
In this study, we investigate whether induction with immunotherapy, followed by chemoradiation as consolidative therapy is an effective bladder-sparing therapy.
Primary objective is to determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended phase dose (RPTD) of the combination of ipilimumab/nivolumab and PHP in patients with unresectable,…
Firstly, the objective of the study is to estimate the safety and tolerability of study treatments (firstly nivolumab alone, and then nivolumab in combination with ipilimumab) in pediatric participants with primary high-grade CNS tumors.Secondly,…