24 results
To assess the safety of a single dose of intravenous EC17 injection in patients with ovarian, lung, breast cancer and parathyroid adenomas. To assess concordance of fluorescent signal and tumor status of resected tissue, in the case of ovarian, lung…
Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
Primary Objective* To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab and its relation to target occupancy (TO) in peripheral blood of patients with classical Hodgkin*s Lymphoma (cHL).Secondary Objectives* To evaluate…
Primary Objectives1. To assess the safety and tolerability of ascending doses of a single IV injection of OTL-0382. To assess the efficacy of ascending doses of a single IV injection of OTL-038 in detecting ovarian, renal cell and endometrial cancer…
To demonstrate superiority with regard to overall survival (OS) of avelumab versus docetaxel in subjects with programmed death ligand 1 (PD-L1) positive (+; as determined by a companion diagnostic test under development), non-small cell lung cancer…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Primary Objectives* Phase 1b lead-in: To assess safety and tolerability of a single dose level of avelumab in combination withincreasing dose levels of other immune modulators in combination with a single doselevel of avelumab in patients with…
To demonstrate that treatment with avelumab in combination with standard of care (SOC) CRT is superior to SOC CRT alone in prolonging progression-free survival (PFS) in front-line patients with high-risk (as defined in Inclusion Criterion 2),…
Feasibility
Primary Objective:• Safety and tolerability of VXM01 in combination with avelumabSecondary Objectives:• Efficacy of VXM01 in combination with avelumab by assessment of tumor objective response rate (ORR) per Immunotherapy Response Assessment in…
Primary Objective* To demonstrate that avelumab given alone or in combination with Pegylatedliposomal doxorubicin (PLD) is superior to PLD alone in prolonging Overall Survival(OS) in patients with platinum -resistant/platinum-refractory ovarian…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
The purpose of this study is to evaluate the safety and preliminary efficacy of avelumab in combination with M9241in subjects with metastatic or locally advanced unresectable solid tumors. This dose escalation study will establish a safe dose of…
The aim of the study is to develop PD-L1 PET/CT imaging in patients with NSCLC to noninvasively image PD-L1 expression in tumors and to determine the correlation with response to avelumab. For this purpose, two studies will be carried out to1:…
1. To assess safety of different doses of a single iv injection of SGM-1012. To assess the performance of SGM-101 in the intraoperative detection of colorectal or pancreas cancer by:a. Tumor-to-background ratio (TBR);b. Concordance between…
To investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk of recurrence .
Co Primary Objectives:1. To demonstrate that avelumab in combination with platinum based chemotherapy followed by avelumab maintenance (Arm C) is superior to platinum based chemotherapy alone followed by observation (Arm A) in prolonging progression…
The evaluation of R-IrAE's after ICI therapy, specifically incidence, treament of R-IrAE's, response to said treatment, baseline and follow-up serology (general and symptom specific) to be combined with quality of life assessment and…
To demonstrate benefit of maintenance treatment with avelumab for a maximum of six months avelumab in increasing overall survival (OS) at 18 months in the whole study population of patients with unresectable locally advanced or metastatic UC who…
Primary Objective:* To evaluate ORR of avelumab in combination with talazoparib, in patients with locally advanced or metastatic solid tumors harboring BRCA1, BRCA2 or ATM defect.Secondary Objective:* To assess the overall safety and tolerability of…