P2, N=58, Active, not recruiting, University of Texas Southwestern Medical Center | Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Jul 2026 --> Jul 2027
1 day ago
Trial completion date • Trial primary completion date • Pan tumor
Patients will be stratified based on programmed death receptor-ligand 1 (PD-L1) tumor expression and randomized (1:1:1) to observation for 10 months (Arm 1), zimberelimab for 13 cycles (Arm 2) or sacituzumab govitecan and zimberelimab for 8 cycles followed by zimberelimab monotherapy for 5 cycles (Arm 3). The primary endpoint is disease-free survival, and secondary endpoints include overall survival and safety.
29 days ago
P3 data • Journal • PD(L)-1 Biomarker • IO biomarker
P2, N=30, Active, not recruiting, Washington University School of Medicine | Trial completion date: Jun 2030 --> Dec 2030 | Trial primary completion date: Apr 2026 --> Oct 2026
1 month ago
Trial completion date • Trial primary completion date
To evaluate the intracranial efficacy, safety, and exploratory immune biomarkers of zimberelimab combined with intracranial hypofractionated radiotherapy in patients with MBM...ChiCTR, ChiCTR2200057001. Registered 25 February 2022 (https://www.chictr.org.cn/showproj.html?proj=153144).
In a phase 1b trial (ARC-8), we evaluated safety and efficacy of quemliclustat combined with gemcitabine/nab-paclitaxel (G/nP) with or without zimberelimab (anti-programmed cell death protein 1 (PD-1)) in first-line metastatic pancreatic ductal adenocarcinoma (PDAC)...High tumor NR4A expression was associated with improved overall survival (OS) in ARC-8 but not in two external cohorts from the PRINCE (G/nP + nivolumab (nivo)) or Morpheus-PDAC (G/nP) trials...In paired pretreatment/posttreatment biopsies, maximal downregulation of NR4A expression was associated with T cell activation and improved OS, pointing to a biological link between tumor adenosine and clinical benefit. ClinicalTrials.gov identifier: NCT04104672 .
3 months ago
P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
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CD73 (5'-Nucleotidase Ecto) • NR4A1 (Nuclear Receptor Subfamily 4 Group A Member 1)