Opdivo (nivolumab)

P1/2, N=38, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Mar 2027 | Trial primary completion date: Jan 2026 --> Mar 2027

In this study, we attempted to identify a molecule that is associated with anti-PD1/PDL1 therapeutic efficacy through proteomic profiling of plasma obtained from patients with advanced gastric cancer (AGC) receiving anti-PD1 nivolumab monotherapy...These suggest that high levels of ANGPTL3 in plasma are a significant risk factor associated with unresponsiveness to anti-PD1 treatment and poor prognosis. Targeting ANGPTL3 in the peripheral circulation may be a promising strategy to improve clinical outcomes in anti-PD1/PDL1 therapy for AGC.

Among cisplatin-ineligible patients with MIBC, nivolumab alone was well tolerated. Ipilimumab/nivolumab caused toxicity that delayed cystectomy. Cases of progression before cystectomy indicated insufficient efficacy of pure neoadjuvant immunotherapy for unselected patients. Despite low response rates, some patients experienced sustained clinical CRs without cystectomy.

P2, N=120, Suspended, Michael B. Atkins, MD | Trial completion date: Oct 2026 --> Nov 2027 | Recruiting --> Suspended | Trial primary completion date: Jan 2026 --> Nov 2026

In post-hoc analyses, median progression-free survival was 26 months (95% CI: 14.7-34.3), and median overall survival was 38 months (95% CI: 27.9-not reached). Exploratory gene expression, immunohistochemistry and spatial transcriptomics showed increased intratumoral plasma cells and CD8 T cells in treated patients versus mFFX-only controls, and lymphoid aggregates with high plasma-cell-to-B cell ratios enriched for terminally exhausted CD8 T cells with fewer progenitor exhausted CD8 T cells and central memory CD4 T cells.

NIC and PC seem to be equally supportable options in the treatment of advanced NSCLC. Further analyses are needed to validate our findings.

P=N/A, N=100, Not yet recruiting, Jinan central hospital; Jinan central hospitalJinan central hospital

P=N/A, N=200, Recruiting, The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

IgG4+CD8+ Temra and VEGF-C levels at RAM+DOC initiation may serve as biomarkers of survival benefit. Trial Registration: UMIN-Clinical Trials Registry (UMIN000050478).

Among patients undergoing nivolumab treatment, CPS ≥1 was significantly associated with longer survival outcomes in CLDN18.2-positive patients, and a tendency toward improved Nivo-OS in TROP2-positive patients.

REVOLUTION cohorts A and B demonstrated encouraging antitumor activity in patients with mPDAC. In cohort B, hydroxychloroquine-related tolerability issues contributed to early discontinuations and reduced drug exposure. These findings highlight the potential and limitations of current chemoimmunotherapy approaches. Although neither cohort will be expanded, the results reinforce the continued promise of chemoimmunotherapy in mPDAC and the importance of refining these strategies.

Trastuzumab first established HER2-targeted therapy in gastric cancer, but the failure of trastuzumab emtansine (T-DM1) led to a decade-long stagnation until the advent of trastuzumab deruxtecan (T-DXd), which demonstrated robust clinical activity and defined a new standard of care. While bevacizumab failed to improve survival, the anti-VEGFR2 antibody ramucirumab emerged as an effective second-line therapy. Immune checkpoint inhibitors, including nivolumab and pembrolizumab, have been incorporated into first-line treatment for PD-L1-positive disease based on landmark trials such as CheckMate 649 and KEYNOTE-811. More recently, the CLDN18.2-targeted antibody zolbetuximab has expanded therapeutic options for biomarker-selected patients. Concurrently, a diverse pipeline of immune-based strategies-such as TROP2-directed ADCs, bispecific antibodies, and CAR-T cell therapies-is undergoing active clinical development. Together, advances in biomarker-driven antibody therapeutics are accelerating personalized cancer care and improving clinical outcomes in patients with gastric cancer.