Zimberelimab

HealthScout AI summary: First-line study for adults with recurrent/metastatic, non-nasopharyngeal HNSCC (ECOG 0–1, measurable disease, no prior PD-1/TIGIT; prior curative-intent platinum allowed if relapse >6 months) comparing zimberelimab (anti–PD-1) plus carboplatin/paclitaxel with or without domvanalimab, an Fc-silent anti-TIGIT antibody that augments T-cell activity. Aims to determine whether adding anti-TIGIT to PD-1 blockade and platinum-taxane chemotherapy improves ORR and PFS.

ClinicalTrials.gov ID: NCT06727565

HealthScout AI summary: Eligible patients are adults with metastatic triple-negative breast cancer and measurable brain metastases who can undergo stereotactic radiosurgery; treatment consists of SRS followed by sacituzumab govitecan (an anti-Trop-2 antibody-drug conjugate) and zimberelimab (a PD-1 inhibitor immunotherapy). Prior taxane/anthracycline or SRS/FSRT therapy (if new lesions) is allowed; key exclusions are leptomeningeal disease, significant comorbidities, active autoimmune disease requiring immunosuppression, and prior topoisomerase I inhibitor use for brain metastases.

ClinicalTrials.gov ID: NCT06238921

HealthScout AI summary: Men with hormone-sensitive oligometastatic prostate adenocarcinoma (1–3 SBRT-amenable lesions; prior definitive therapy; testosterone >125 ng/dL; PSA 0.5–50; PSADT <15 months; ECOG 0–2) receive metastasis-directed SBRT plus adenosine-axis modulation with quemliclustat (CD73 inhibitor) and etrumadenant (A2A/A2B receptor antagonist) followed by PD-1 blockade with zimberelimab. Aims to improve biochemical and radiographic control versus historical SBRT alone while deferring ADT.

ClinicalTrials.gov ID: NCT05915442

HealthScout AI summary: Adults with metastatic pancreatic adenocarcinoma/squamous histology who have at least stable disease after 4–6 months of first‑line FOLFIRINOX are randomized to switch‑maintenance immunotherapy with domvanalimab (anti‑TIGIT) + zimberelimab (anti‑PD‑1) + APX005M/sotigalimab (CD40 agonist) versus continued maintenance FOLFIRI. Key exclusions include progression on FOLFIRINOX, prior checkpoint or CD40 therapy, significant autoimmune disease, active HBV/HCV/HIV, and germline BRCA1/2 mutations; crossover to the immunotherapy arm at progression is allowed.

ClinicalTrials.gov ID: NCT05419479

HealthScout AI summary: Adults with ECOG 0–1: dose escalation enrolls any advanced solid tumor lacking standard options; expansion enrolls histologically confirmed ccRCC. Treatments include the oral HIF-2α inhibitor casdatifan (AB521) as monotherapy or combined with cabozantinib or the anti–PD-1 antibody zimberelimab.

ClinicalTrials.gov ID: NCT05536141

HealthScout AI summary: This trial enrolls adults with newly diagnosed stage IV NSCLC without EGFR, ALK, ROS1, NTRK, BRAF, RET, or other actionable mutations, randomizing them to standard chemotherapy plus either pembrolizumab (PD-1 inhibitor), zimberelimab (PD-1 inhibitor), or zimberelimab combined with domvanalimab (TIGIT inhibitor) as first-line therapy. Eligible patients must have good performance status (ECOG 0-1) and no prior immune checkpoint inhibitor exposure.

ClinicalTrials.gov ID: NCT05502237

HealthScout AI summary: Adults with cutaneous melanoma (non-mucosal/ocular/acral) that has progressed on prior anti–PD-1/L1 therapy receive zimberelimab (anti–PD-1) plus domvanalimab (Fc-silent anti-TIGIT) every 3 weeks, with continuation for disease control up to 24 months. Prior CTLA-4 and, if BRAF-mutant, BRAF/MEK therapy allowed; requires ECOG 0–1, excludes active autoimmune disease, prior TIGIT therapy, and uncontrolled/active CNS disease (treated, stable brain mets allowed).

ClinicalTrials.gov ID: NCT05130177