Opdivo (nivolumab)

P1/2, N=480, Recruiting, Parabilis Medicines, Inc. | N=245 --> 480

P1/2, N=7, Completed, Servier Bio-Innovation LLC | Active, not recruiting --> Completed | N=92 --> 7 | Trial completion date: Mar 2026 --> Nov 2024 | Trial primary completion date: Mar 2026 --> Nov 2024

Patients with pleural mesothelioma treated with nivolumab and ipilimumab with or without UV1 vaccine in the NIPU study were included. Elevated levels of certain cytokines, both before and after onset of treatment, correlate with specific irAEs in PM patients receiving ICIs. These cytokines may be used as biomarkers to predict and detect irAES.

By blocking this interaction, checkpoint inhibitors such as nivolumab and pembrolizumab have demonstrated high response rates in patients with cHL, particularly in those who have not responded to conventional therapies. By understanding how TNF signaling interacts with immune checkpoints, researchers can design more effective treatment regimens that simultaneously target multiple pathways. Combining TNF inhibitors with checkpoint blockade therapies may enhance the overall anti-tumor response by addressing both direct tumor signaling and the immune evasion mechanisms employed by tumor cells.

Higher TMB was associated with objective response to ICI, however, TMB was an imperfect biomarker for PFS and OS in our study.

P=N/A, N=101, Completed, Bristol-Myers Squibb

P1/2, N=607, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | N=425 --> 607

P2, N=40, Recruiting, ImmunityBio, Inc. | Active, not recruiting --> Recruiting | N=147 --> 40

ICIs show potential for treating recurrent HCC after liver transplantation, but the risk of graft rejection is significant. Careful patient selection, close monitoring, and individualized management of immunosuppression are crucial. Positive PD-L1 expression and the choice of immunosuppressive regimen appear to influence the risk of graft rejection; however, these findings are based on limited data. Prospective studies with larger sample sizes are needed to validate these findings and establish evidence-based guidelines for the use of ICIs in the post-transplant setting.

These genomic data highlight the importance of immune infiltration and antigen presentation in dMMR tumors that respond to immune checkpoint blockade. In addition, they suggest that, even within a dMMR population, NGS based measures of MSI could serve as biomarkers of immunotherapy response.

Linrodostat + nivolumab ± ipilimumab demonstrated a manageable safety profile. Kynurenine changes supported IDO1 pathway inhibition but did not correlate with response. A composite biomarker of low TDO2 expression plus high IFN-γ gene expression may predict response to linrodostat + nivolumab.

P2, N=73, Not yet recruiting, UNICANCER | Initiation date: Oct 2024 --> Jan 2025

P=N/A, N=500, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> Dec 2024

P2, N=80, Recruiting, Dan Zandberg | Trial completion date: Sep 2027 --> Sep 2026 | Trial primary completion date: May 2027 --> May 2026

P2, N=20, Not yet recruiting, Emory University

P1, N=21, Terminated, Navire Pharma Inc., a BridgeBio company | N=45 --> 21 | Trial completion date: Jan 2025 --> Jul 2024 | Recruiting --> Terminated; Business reasons

P1, N=29, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Mar 2026 --> Dec 2024 | Trial primary completion date: Mar 2026 --> Dec 2024

P=N/A, N=40, Completed, ARCAGY/ GINECO GROUP | Active, not recruiting --> Completed

P=N/A, N=825, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting

P3, N=925, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed

In a first-in-human phase 1-2a study (GDFATHER-1/2a trial, NCT04725474 ), patients with advanced cancers refractory to anti-PD-1 or anti-PD-L1 therapy (termed generally as anti-PD-1/PD-L1 refractoriness) were treated with the neutralizing anti-GDF-15 antibody visugromab (CTL-002) in combination with the anti-PD-1 antibody nivolumab. Increased levels of tumour infiltration, proliferation, interferon-γ-related signalling and granzyme B expression by cytotoxic T cells were observed in response to treatment. Neutralizing GDF-15 holds promise in overcoming resistance to immune checkpoint inhibition in cancer.

P3, N=1147, Recruiting, Bristol-Myers Squibb | N=831 --> 1147 | Trial primary completion date: Jun 2025 --> Aug 2024

P=N/A, N=115, Active, not recruiting, Bristol-Myers Squibb | Not yet recruiting --> Active, not recruiting

P1/2, N=325, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed

P1/2, N=21, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P2, N=22, Active, not recruiting, Brown University | Trial completion date: Jul 2024 --> Jan 2025

P2, N=25, Recruiting, University of Utah | Initiation date: Nov 2024 --> Feb 2025

P2, N=68, Recruiting, Fudan University

P2, N=103, Active, not recruiting, University of Sydney | Completed --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Jun 2024

P1/2, N=20, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Feb 2026 --> Jan 2025

P1, N=30, Recruiting, City of Hope Medical Center | Suspended --> Recruiting

P1, N=44, Active, not recruiting, University Hospital Southampton NHS Foundation Trust | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2024 --> May 2025

"Agilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and Opdualag (nivolumab and relatimab)....PD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma."

P1, N=6, Terminated, Mayo Clinic | Trial completion date: Jul 2025 --> Apr 2024 | Active, not recruiting --> Terminated; Lack of funding

P1/2, N=125, Active, not recruiting, Eisai Co., Ltd. | Phase classification: P1b/2 --> P1/2 | Trial completion date: Jan 2024 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026

P2, N=35, Completed, HonorHealth Research Institute | Active, not recruiting --> Completed | N=10 --> 35 | Trial completion date: Dec 2023 --> Mar 2024

P1/2, N=46, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Completed | N=30 --> 46 | Trial completion date: Dec 2024 --> Sep 2024 | Trial primary completion date: Dec 2024 --> Sep 2024

Clinical trials of ICI treatment including Nivolumab, Pembrolizumab, Avelumab have been conducted for metastatic GC (mGC). However, not all PD-L1 positive patients can benefit from it. It is urgent to find better biomarkers to predict the response of ICIs for more precise clinical treatment.

P2, N=16, Terminated, ImmuneSensor Therapeutics Inc. | N=51 --> 16 | Trial completion date: Feb 2026 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Nov 2024; Change in ImmuneSensor corporate strategy

Trastuzumab with chemotherapy is the standard regimen for HER2-positive GC/GEJC. While, for HER2-negative cases, chemotherapy with or without immune checkpoint inhibitors (ICIs)such as nivolumab or pembrolizumab are regarded as the standard therapy...We will highlight the previous clinical trials of zolbetuximab and provide future perspective of CLDN18.2 targeted therapy. In addition, we will introduce the ongoing development of various CLDN18.2 targeting therapies such as newer monoclonal antibodies, antibody-drug conjugates(ADCs), chimeric antigen receptor T-cell(CAR- T)therapy, and bispecific antibodies.

Immune checkpoint inhibitors, including anti-PD1 agents like nivolumab, are linked to immune-related adverse events related to widespread T cell activation, potentially increasing IL17 signaling associated with HS [2,3]. Clinicians should be aware of, and observant for anti-PD1-induced HS, a rare immune-related adverse event, in patients undergoing immune checkpoint inhibitor therapy.

Finding suggests that immune checkpoint inhibitors combined with chemotherapy could enrich patients with benefits regardless of CPS grades, though subtle efficacy in low CPS subgroups. This study compared the efficacy of different immunotherapies combined with chemotherapy in patients with gastric cancer, but we acknowledge some differences between reconstructed and original data. Hopefully there will be more research investigating comparisons between current therapies rather than with chemotherapy only in the future.