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

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.

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

P=N/A, N=13, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Sep 2025

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=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=40, Recruiting, Anwaar Saeed | Not yet recruiting --> Recruiting

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

P2, N=60, Not yet recruiting, MacroGenics

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

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

Unfortunately, the patient progressed rapidly during maintenance therapy when cadonilimab was replaced by sintilimab, the monoclonal antibody against PD-1, indicating the more powerful anti-tumor activity of dual blockade immunotherapy. To conclude, cadonilimab offers a promising and effective therapeutic approach for R/M CC. Notably, HER-2 is also expected to be a new reference target for cadonilimab therapy.

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

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=23, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

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

P3, N=110, Recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Sep 2025

P2, N=32, Recruiting, The University of Texas Health Science Center at San Antonio | Not yet recruiting --> Recruiting

Results showed antitumour activity and manageable safety with NIVO + RELA. Findings also support NIVO + IPI as an effective combination regimen in IO-naive patients with aRCC.

The INFINITY study provided promising activity results of a chemo-free T300/D combination regimen as pre-operative treatment in dMMR/MSI GAC/GEJAC and the first available feasibility results of a NOM strategy in this disease setting, worth of further validation in larger cohorts.

We reviewed cfDNA results from a local prospective solid tumour cohort (PREDiCT-l) and two randomized trials: CCTG CO.26 (durvalumab + tremelimumab [D+T] or best supportive care in metastatic colorectal cancer) and CCTG PA.7 (gemcitabine and nab-paclitaxel +/- D+T in metastatic pancreatic adenocarcinoma). CHIP is common in patients with solid tumours. Although not appearing to impact rates of adverse events, CHIP may impact outcomes from immunotherapy or chemotherapy.

Eligible patients will be registered and receive three cycles of oxaliplatin and S-1 (SOX) regimen in combination with cadonilimab...The results of the study may provide more evidence for neoadjuvant immunotherapy combined with chemotherapy in locally advanced G/GOJ adenocarcinoma. ClinicalTrials.gov, NCT05948449.

P2, N=32, Completed, Spanish Oncology Genito-Urinary Group | Active, not recruiting --> Completed

P=N/A, N=3, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | N=60 --> 3 | Trial completion date: Nov 2024 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Nov 2024 --> May 2024; Recruitment challenges: competition with another microbiome trial, patient refusal to join a dietary intervention study, poor tolerance of oral DPD (Grade 2 mucositis), and issues with organizing biological sample collection.

P2, N=29, Active, not recruiting, Sheba Medical Center | Recruiting --> Active, not recruiting

P2, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Recruiting

P2, N=30, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025

P3, N=906, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed

P=N/A, N=20, Not yet recruiting, First Affiliated Hospital of Ningbo University

Furthermore, patients who received 1L platinum/pemetrexed chemotherapy are often considered for second or further-line (2L+) ipi-nivo on the basis of MAPS2 results. The highest-grade TRAE was 1 to 2 in 58% of these patients and 3 or higher in 42% Treatment discontinuation due to a TRAE occurred in 22% of patients. In this real-world cohort of patients with MPM treated with ipi-nivo survival outcomes were inferior to those reported in the CheckMate-743 and MAPS2 trials, whereas safety outcomes were similar.

P=N/A, N=20, Enrolling by invitation, Hubei Cancer Hospital

P1, N=36, Recruiting, Transgene | Trial completion date: Mar 2025 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Apr 2025

P2, N=60, Not yet recruiting, Stanford University

P2, N=51, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting

P1/2, N=46, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2025 --> Apr 2027 | Trial primary completion date: Oct 2024 --> Apr 2026

P1/2, N=104, Completed, University of Pennsylvania | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Oct 2024