67 results
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:* Phase 1b:o Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of binimetinib administered in combination with nivolumabo Determine the MTD and RP2D of binimetinib administered in combination with nivolumab plus…
PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…
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…
To determine the real-world pharmacokinetics of ICIs.
In this study, we investigate whether induction with immunotherapy, followed by chemoradiation as consolidative therapy is an effective bladder-sparing therapy.
Primary ObjectiveTo determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for: infusion related reaction during…
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…
Primary ObjectivesPart 1 (Monotherapy Dose Escalation Phase):* To determine the recommended Phase 2 dose (RP2D) of SQZ AAC HPV monotherapy. * To characterize the safety and tolerability of SQZ AAC HPV administered as monotherapy. Part 2 (Combination…
• To assess the relation between 18F-PD-L1 PET/CT outcome measures and progression-free survival of >=9 months according to RECIST 1.1.• To assess the relation between 18F-PD-L1 PET/CT outcome measures and patient outcome in terms of PFS and…
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…
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 objectiveTo determine the pathological complete response rate per cohort
Primary Objectives: - To characterize the safety, tolerability, and DLTs and to determine the MTD/RP2D of BMS-986218 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors- To evaluate the efficacy…
Primary objectives: - To assess safety and feasibility of neoadjuvant nivolumab +/- domatinostat +/- ipilimumab- To identify pathologic response rates of nivolumab +/- domatinostat +/- ipilimumabSecondary objectives: - To describe all grade…
Primary objectives - To evalulate the association between baseline tissue TMB/blood TMB and clinical efficacy (Objective Response Rate) for participants in Part 2- To evaluate the correlation between baseline tissue TMB and blood TMB for…
Primary Objectives• To compare the of OS rate at 12 months of Nivolumab combined with Ipilimumab to standard of care in patients with previously untreated and advanced non-clear cell RCC, Secondary Objectives• To compare the OS rate at 6 and 18…
*In the phase Ib study: to assess the feasibility and safety of the addition of nivolumab and/or ipilimumab to MMC/capecitabine chemoradiation of the bladder.*In the phase II study: to assess the impact of the addition of the addition of nivolumab…
Primary objectives: 1. Establish whether a sequenced pre-operative schedule of ipilimumab and nivolumab is safe in urothelial cancer patients (cohort 1)Secondary objectives: 2. Dissect the tumor micro-environment of urothelial cancers before and…