P1/2, N=34, Terminated, Pfizer | Active, not recruiting --> Terminated; Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions

P2, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027

P2, N=14, Active, not recruiting, Georgetown University | Trial completion date: Dec 2023 --> Dec 2024

P1, N=200, Recruiting, BeiGene | Active, not recruiting --> Recruiting | N=37 --> 200 | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026

P1, N=163, Active, not recruiting, AbbVie | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Mar 2025 --> Sep 2025

P2, N=32, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Nov 2024 --> Nov 2025

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.

In each case, checkpoint blockade led to durable radiographic responses. We therefore propose that it is reasonable to assess combined positive score and tumor mutational burden in refractory or recurrent pancreatic cancers when initiation of ICB is being considered.

Pembrolizumab alone or combined with chemotherapy indicates an effective and safe treatment for metastatic cancer. Pembrolizumab alone or combined with chemotherapy provides a better survival advantage under first-line treatment or programmed cell death ligand 1 combined positive scores of at least 10 or programmed cell death ligand 1 tumor proportion scores of at least 50%. However, we found that the specific efficacy of pembrolizumab in unused tumor types could not be effectively evaluated.

This review analyzes the current landscape of existing randomized clinical trials, highlighting the efficacy of immune checkpoint inhibitors (ICIs) like pembrolizumab, avelumab, and dostarlimab. These findings underscore the importance of tailoring treatments based on the molecular characteristics of each tumor and paving the way for future advancements in the field of gynecologic oncology. Despite promising results, this article acknowledges the necessity of further research to refine patient selection criteria and explore combination strategies that can overcome resistance mechanisms.

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.

This subgroup of IO-responsive NS-pts may have better prognosis. Our findings suggest that DDR-based mutational profiling may help identify NS-pts who could benefit from IO therapy.

Key to immunotherapy efficacy in EC is the tumor's mismatch repair status, with MMR-deficient tumors demonstrating a higher tumor mutational burden and increased PD-L1 expression, making them more susceptible to immune checkpoint inhibitors (ICIs) such as pembrolizumab, durvalumab, and dostarlimab. To overcome resistance in cold tumors, novel therapies, including Chimeric Antigen Receptor (CAR) T cells and tumor-infiltrating lymphocytes are being explored, offering targeted immune-based strategies to enhance treatment efficacy. This review discusses the current understanding of immunotherapy in EC, emphasizing the prognostic and therapeutic implications of MMR status, TME composition, and emerging cell-based therapies.

Considering the frailty associated with cachexia, ICI monotherapy may be preferred to ICI/chemotherapy for these patients. New interventions that can better address the negative prognostic impact of cachexia in patients treated using ICIs with or without chemotherapy remain warranted.

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

This project validated that the loss of P2RX1 in neutrophils induces CD8+ T cell dysfunction and affects the GC development, indicating that P2RX1 may be an accurate biomarker for predicting ICI response, thus providing a theoretical basis for the clinical application of ICI.

Atirizumab, duvalizumab, atezolizumab, and serplulimab can significantly improve the clinical outcomes of SCLC. Finally, we clarified that the emerging trend of low-dose radiotherapy help overcome the inhibitory signals that limit T-cell infiltration in the tumor matrix. In summary, considering the rapid development of this field, these combined therapy strategies may have unlimited potential to further improve the efficacy of radiotherapy combined with immunotherapy for patients.

P1, N=41, Not yet recruiting, VLP Therapeutics

P1/2, N=24, Active, not recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Sep 2023 --> May 2025

P3, N=300, Recruiting, Sun Yat-sen University

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=78, Recruiting, Akeso | Not yet recruiting --> Recruiting | N=60 --> 78 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025

P2, N=100, Recruiting, Fudan University | Not yet recruiting --> Recruiting

P2, N=90, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Recruiting

P2, N=60, Not yet recruiting, Sun Yat-sen University

This study suggests that immunotherapy is less beneficial in SCC-MU. More work is needed to verify our findings and explore other treatment options.

Some elderly patients with NSCLC and high PD-L1 expression might benefit from COMB; however, MONO is considered the preferred treatment. MONO may not be an effective or feasible treatment for patients with PS 2-3, even with high PD-L1 expression.

Baseline 68Ga-NOTA-WL12 PET/CT has a potential to predict the pathological response of neoadjuvant immunotherapy combined with chemotherapy in patients with resectable NSCLC, whose efficacy is comparable to that of therapy evaluations employing baseline and follow-up CT and 18F-FDG PET/CT examinations.

Improvements in ORR and PFS for L+P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and molecular subtypes.

The study developed and validated a deep learning radiomic biomarker using pretreatment routine CT/PET-CT scans to identify ICI benefit in advanced NSCLC.

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.

P=N/A, N=40, Recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna

P2, N=90, Not yet recruiting, Merck Sharp & Dohme LLC

Considering the interplay between cancer, inflammation, and immunosuppression, we hypothesized that circulating and imaging inflammatory markers could serve as indicators of anti-tumor immune responses, and thus conducting an exploratory study to reveal the predictive value of combining longitudinal systemic inflammatory markers in stratifying pathologic response to neoadjuvant sintilimab...The combination of pre-treatment SLR and ΔNLR% demonstrates predictive value in stratifying pathologic response to neoadjuvant immunotherapy in resectable NSCLC. The high inflammatory burden group had the lowest pathologic regression and the pre-treatment immunosuppressive microenvironment with macrophage enrichment.

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

To the best of our knowledge, this is the first clinical case report in the literature describing the benefit of anlotinib and sintilimab treatment for non-small cell lung cancer with RET fusion and high PD-L1 expression. This study explores the biomarker selection for targeted therapy and combined immunotherapy in NSCLC patients.

P2, N=129, Recruiting, Fudan University | Not yet recruiting --> Recruiting

P2, N=320, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Nov 2025 --> Jun 2027 | Trial primary completion date: Oct 2025 --> Jun 2026

P2, N=19, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025