Imjudo (tremelimumab)

P2, N=28, Recruiting, Georgetown University | Initiation date: Mar 2024 --> Jun 2024

In the whole-population network meta-analysis, the newly first-line tremelimumab plus durvalumab (Tre + Du) was found to be comparable with atezolizumab plus bevacizumab (Atezo + Beva) in providing the best overall survival (OS) benefit [hazard ratio (HR) 1.35, 95% confidence interval (CI): 0.93-1.92]. Concerning OS benefits, sintilimab plus bevacizumab biosimilar (Sint + Beva), camrelizumab plus rivoceranib (Camre + Rivo), and lenvatinib plus pembrolizumab (Lenva + Pemb) appear to exhibit similar effects to Tre + Du and Atezo + Beva...With lower incidence rates of treatment-related adverse events and non-inferior efficacy compared to sorafenib, ICI monotherapies should be prioritized as a first-line treatment approach for patients who are not suitable candidates for ICI-combined therapies. PROSPERO, CRD42022288172.

P2, N=31, Active, not recruiting, Seoul National University Hospital | Trial completion date: Dec 2023 --> Dec 2024

P3, N=48, Recruiting, Maximilian Diehn | Trial completion date: Mar 2026 --> Apr 2028 | Trial primary completion date: Mar 2024 --> Apr 2026

P=N/A, N=300, Recruiting, AstraZeneca | Trial completion date: Oct 2024 --> Dec 2026 | Trial primary completion date: Oct 2024 --> Dec 2026

P2, N=120, Completed, University of Erlangen-Nürnberg Medical School | Active, not recruiting --> Completed

P2, N=30, Recruiting, Assistance Publique - Hôpitaux de Paris | Not yet recruiting --> Recruiting | Trial completion date: Jan 2026 --> Sep 2027 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Feb 2025 --> Sep 2026

No abstract available

P2, N=150, Recruiting, Prisma Health-Upstate | Trial completion date: Dec 2026 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Feb 2026

To determine the efficacy of 1 or 2 immune checkpoint inhibitors combined with FOLFIRI (leucovorin [folinic acid], fluorouracil, and irinotecan) in the treatment of advanced gastric/GEJ adenocarcinoma. Combination of immune checkpoint inhibitors with FOLFIRI in second-line treatment for advanced gastric/GEJ adenocarcinoma showed an acceptable safety profile but antitumor activity only in a subgroup of patients. ClinicalTrials.gov Identifier: NCT03959293.

P2, N=38, Recruiting, National Cancer Institute, Naples

P1/2, N=54, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Trial primary completion date: Jun 2023 --> Jun 2024

P2 | N=48 | NCT03737968 | "Lunit... announced the publication of a new study featuring Lunit SCOPE IO, Lunit's AI-powered analyzer for quantitative immune phenotyping from H&E...This investigation addresses the current lack of exploration into the clinical implications of neoadjuvant immunotherapy in HNSCC patients with resectable tumors, utilizing Lunit SCOPE IO to examine the changes in tumor microenvironment when treated with durvalumab and tremelimumab...In this phase II randomized clinical trial, 48 HNSCC patients were enrolled, with 24 receiving preoperative durvalumab and 24 receiving a combination of durvalumab plus tremelimumab before surgical resection....The study findings revealed that patients treated with the combination of durvalumab and tremelimumab exhibited significantly better 4-year distant recurrence-free survival (DRFS) compared to those receiving durvalumab monotherapy (91.1% vs. 53.3%)..."

Analysis of the tumor microenvironment after combination immunotherapy did not show a significant change in immune cell subsets from baseline. There was limited benefit for dual checkpoint blockade administered prior to NACT in our study of 8 patients with HR+/HER2-negative breast cancer.

P1/2, N=20, Active, not recruiting, University of Alabama at Birmingham | Recruiting --> Active, not recruiting

Atezolizumab + bevacizumab (atezo + bev) or durvalumab + tremelimumab (durva + treme) may be offered first-line for patients with advanced HCC, Child-Pugh class A liver disease, and Eastern Cooperative Oncology Group performance status 0-1. Where there are contraindications to these therapies, sorafenib, lenvatinib, or durvalumab may be offered first-line. Following first-line treatment with atezo + bev, second-line therapy with a tyrosine kinase inhibitor (TKI), ramucirumab (for patients with alpha-fetoprotein [AFP] ≥400 ng/mL), durva + treme, or nivolumab + ipilimumab (nivo + ipi) may be recommended for appropriate candidates. Following first-line therapy with durva + treme, second-line therapy with a TKI is recommended. Following first-line treatment with sorafenib or lenvatinib, second-line therapy options include cabozantinib, regorafenib for patients who previously tolerated sorafenib, ramucirumab (AFP ≥400 ng/mL), nivo + ipi, or durvalumab; atezo + bev or durva + treme may be considered for patients who did not have access to these therapies in the first-line setting, and do not have contraindications. Pembrolizumab or nivolumab are also options for appropriate patients following sorafenib or lenvatinib. Third-line therapy may be considered in Child-Pugh class A patients with good PS, using one of the agents listed previously that has a nonidentical mechanism of action with previously received therapy. A cautious approach to systemic therapy is recommended for patients with Child-Pugh class B advanced HCC. Further guidance on choosing between options is included within the guideline.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.

P1/2, N=56, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Dec 2024

P2, N=60, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jun 2025 --> Apr 2031 | Trial primary completion date: Jun 2024 --> Apr 2030

The patients were enrolled in clinical trials for immune checkpoint inhibitors (ICIs), including nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and camrelizumab. For the patients who were treated with immunotherapy alone (n=64), a similar PFS advantage was observed in the high PD-L1 group (2.8 vs. 8.0 months, P=0.002). This article presented the first data on TEP-derived PD-L1 mRNA in advanced NSCLC patients following immunotherapy and showed the potential advantage of using it as the surrogate biomarker for predicting the PFS and overall survival of patients following immunotherapy.

The CTLA-4 inhibitors, such as ipilimumab and tremelimumab, have been approved for early-stage clinical trials and have shown promising outcomes in terms of tumor regression and durable responses in patients with advanced HNSCC. However, further research is needed to optimize treatment regimens, identify predictive biomarkers, and overcome potential resistance mechanisms. With ongoing advancements in immunotherapy, the future holds great potential for transforming the landscape of oral tumor treatment and providing new hope for patients.

P2, N=180, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Dec 2023 --> Dec 2024

Preoperative D+/-T is feasible and may benefit patients with resectable HNSCC. Distinct changes in the tumor microenvironment and circulating immune cells were induced by each treatment regimen, warranting further investigation.

P2, N=13, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025

bTMB demonstrated potential utility for selecting patients with R/M HNSCC who benefited from durvalumab with or without tremelimumab versus EXTREME. Trial registration ClinicalTrials.gov identifier NCT02551159.

The hepatic arterial infusion chemotherapy of fluorouracil, leucovorin, and oxaliplatin (HAIC-FO) showed OS and PFS benefits over all the other therapies. In terms of OS, HAIC-FO, nivolumab, and TACE+Len were superior to sorafenib, lenvatinib, and donatinib monotherapies, as well as HAIC-FO+Sor. In terms of PFS, TACE+Len showed better benefits than lenvatinib, donatinib, and tremelimumab+durvalumab...The SUCRA score for OS ranked HAIC-FO+sorafenib as the best treatment option among all multimodality treatments in hepatitis B, MVI, or PVTT with EHS and AFP 400 μg/L subgroups. HAIC-FO and HAIC-FO+sorafenib are statistically better options for unresectable hepatocellular carcinoma with PVTT among the multimodality treatments, and their effective and safe implementation may provide the best outcomes for HCC-PVTT patients.

P2, N=200, Active, not recruiting, Canadian Cancer Trials Group | Recruiting --> Active, not recruiting | N=600 --> 200

P1/2, N=58, Completed, Asan Medical Center | Active, not recruiting --> Completed

P1/2, N=53, Active, not recruiting, The Netherlands Cancer Institute | Trial completion date: May 2025 --> Jan 2025

P1, N=53, Completed, Abramson Cancer Center at Penn Medicine | Active, not recruiting --> Completed | N=30 --> 53 | Trial completion date: Dec 2024 --> Jun 2023 | Trial primary completion date: Dec 2024 --> Jun 2023

P2, N=72, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P2, N=40, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Feb 2024 --> Oct 2024

P1, N=32, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=105, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Dec 2024

P2, N=301, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Dec 2023 --> Dec 2024

P2, N=600, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=30, Active, not recruiting, Abramson Cancer Center at Penn Medicine | Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024

P1, N=153, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Dec 2023 --> Dec 2024

P2, N=433, Active, not recruiting, MedImmune LLC | Trial completion date: Dec 2023 --> Mar 2025

P3, N=953, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Dec 2024

P2, N=72, Recruiting, National Cancer Institute (NCI) | N=39 --> 72

P2, N=900, Recruiting, Centre Leon Berard | N=560 --> 900 | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Jan 2025 --> Jan 2026

P2, N=270, Active, not recruiting, Centre Georges Francois Leclerc | Recruiting --> Active, not recruiting | Trial completion date: Jun 2029 --> Aug 2027 | Trial primary completion date: Feb 2023 --> Aug 2027