8 results
The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6 cycles at a dose of 7.4 Gigabecquerel (GBq) (200 Millicuries (mCi)) +/- 10%, improves the radiographic progression free survival (rPFS) or death compared to a change in…
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…
The primary objective:To determine the safety and tolerability of 89Zr*DFO*REGN5054 alone and in combination with cemiplimab.Secondary ObjectivesFor Part A:• To characterize the radioactivity pharmacokinetic (PK) profile of 89Zr DFO REGN5054• To…
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patientswith mHSPC.In this study, the SoC is defined as a combination of Androgen…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).The secondary objectives of the study are:• To characterize the…
Primary objective: 1) To evaluate the overall response rate (ORR) after 24 weeks of cemiplimab in secondary angiosarcomas, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 or daylight photography as per WHO Offset Publication…
Primary Objectives: Dose Escalation (SAR441000 Monotherapy): -To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the overall safety and tolerability profile of SAR441000 when administered intratumorally as…