Imfinzi (durvalumab)

P3, N=290, Not yet recruiting, ETOP IBCSG Partners Foundation

Integrated radiomics, tissue, and plasma-based analyses, may potentially uncover immunotherapeutic response signatures, enabling early, adaptive therapeutic adjustments. By specifically targeting current therapeutic challenges, outcomes for GBM patients may potentially be improved.

P2, N=36, Not yet recruiting, Insel Gruppe AG, University Hospital Bern | Initiation date: Sep 2024 --> Dec 2024

P3, N=805, Active, not recruiting, AstraZeneca | Trial completion date: Aug 2027 --> Apr 2027

P2, N=40, Not yet recruiting, Anwaar Saeed

P2, N=30, Recruiting, Mayo Clinic | Trial completion date: Nov 2025 --> Jan 2027 | Trial primary completion date: Nov 2024 --> Jan 2027

P=N/A, N=45, Active, not recruiting, Maastricht Radiation Oncology | Recruiting --> Active, not recruiting | N=80 --> 45 | Trial completion date: Apr 2024 --> Dec 2025 | Trial primary completion date: Apr 2024 --> Jul 2024

P2, N=40, Completed, Roswell Park Cancer Institute | Active, not recruiting --> Completed

This study demonstrates the feasibility, safety and preliminary efficacy of MEDI5395 with durvalumab in patients with advanced solid tumors.

P2, N=64, Recruiting, National Cancer Center Hospital East | N=37 --> 64 | Trial completion date: Mar 2025 --> Mar 2029 | Trial primary completion date: Mar 2024 --> Mar 2028

P2, N=200, Not yet recruiting, Peking University Shenzhen Hospital

The data presented in this study are consistent with the results of TOPAZ1 trial. However about a third of patients do not respond to CHT or have a short response duration. In our experience both NLR and basal elevated AST/ALT seem to be associated with an improved mPFS and a better outcome but further studies are needed.

D+T is active in mCRPC but patient selection remains a challenge. Further studies to develop predictive biomarkers are warranted.

These monoclonal antibodies target immune checkpoints, including cytotoxic T-lymphocyte-associated protein 4 (ipilimumab and tremelimumab), programmed death 1 (nivolumab, pembrolizumab, cemiplimab, and dostarlimab), programmed death ligand 1 (atezolizumab, avelumab, and durvalumab), and lymphocyte activation gene 3 (relatlimab), and effectively augment the immune response against tumor cells. Despite clinical improvements with immunomodulatory therapy, with corticosteroids the mainstay of treatment, mortality remains high, particularly in those with associated myocarditis or respiratory failure requiring intubation, where mortality occurs in up to 50%. ICI withdrawal can lead to cancer progression and death, highlighting a need for improved approaches to ICI rechallenge, performed in limited patients with variable success to date.

P2, N=30, Completed, Northern Sydney Local Health District | Recruiting --> Completed

P2, N=194, Active, not recruiting, AstraZeneca | Trial completion date: Jun 2025 --> Oct 2025

P2, N=0, Withdrawn, Georgetown University | N=28 --> 0 | Recruiting --> Withdrawn

P2, N=79, Terminated, Grupo Espanol de Tumores Neuroendocrinos | Trial completion date: Dec 2025 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Nov 2024; In compliance with current legislation applicable to Clinical Trials, following the instructions of the Spanish Agency for Medicines and Health Products.

P1/2, N=19, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=12 --> 19

P2, N=21, Not yet recruiting, Mario Negri Institute for Pharmacological Research

P2, N=13, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 13

The treatment regimen comprised durvalumab, tremelimumab, carboplatin, and nab-paclitaxel. Clinicians should be aware that COVID-19 might be associated with the development of severe irAEs and unexpectedly enhanced antitumor effects. The findings also suggest new fields of study regarding the interaction between viral infection and tumor immune response, which may inform future therapeutic approaches.

The combination of durvalumab and acalabrutinib showed encouraging preliminary clinical activity in a heavily pre-treated cohort with relapsed/refractory aggressive B-cell lymphoma. The combination was well tolerated and deliverable to a predominantly elderly and frail population and warrants further study in this context.

P1, N=18, Terminated, The Netherlands Cancer Institute | N=34 --> 18 | Trial completion date: Jan 2021 --> Nov 2024 | Unknown status --> Terminated | Trial primary completion date: Jan 2021 --> Nov 2024; Based on initially defined safety rules not continued with expansion phase of study (too much toxicity with neo-adjuvant immunotherapy)

P1, N=60, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Oct 2024 | Trial primary completion date: Jan 2025 --> Oct 2024

P2, N=69, Completed, Queen Mary University of London | Active, not recruiting --> Completed | N=181 --> 69 | Trial completion date: Mar 2023 --> Jul 2024 | Trial primary completion date: Mar 2023 --> Jul 2024

P1/2, N=27, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2027 --> Aug 2029 | Trial primary completion date: Feb 2027 --> Aug 2028

P1/2, N=22, Terminated, University of Maryland, Baltimore | Trial completion date: Jun 2037 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2032 --> Jun 2024; Limited Accrual

In the studied cohort, OS was significantly shorter for patients ≥ 75 years of age treated with cCRT followed by durvalumab compared to those < 65 years. Post-progression systemic therapy was associated with modest efficacy, underscoring the need for new therapies.

P2, N=54, Recruiting, Australasian Gastro-Intestinal Trials Group | Trial completion date: Jan 2028 --> Jul 2029

P=N/A, N=700, Recruiting, AstraZeneca | N=1500 --> 700

P1/2, N=383, Active, not recruiting, MedImmune LLC | Trial completion date: Sep 2024 --> Sep 2025

P2, N=130, Not yet recruiting, Johnson & Johnson Enterprise Innovation Inc.

Although the present study involved a small number of patients, the findings suggest that the efficacy of tremelimumab plus durvalumab may be affected by WNT/β-catenin signaling and CD8+ TIL infiltration.

Two patients, a 67-year-old female and a 60-year-old man, with biopsy-proven advanced unresectable cholangiocarcinoma, received a combination of systemic therapy with durvalumab, gemcitabine, and cisplatin and subsequently Y90-RE...Immunotherapy in the form of durvalumab and now pembrolizumab alongside chemotherapy is an approved first-line standard of care...This report highlights the development of ITP in 2 patients who received durvalumab alongside Y90-RE. Awareness of this as a potential immune-mediated event is important to allow for close monitoring of platelet counts and for early intervention/management when this occurs.

P2, N=50, Active, not recruiting, AstraZeneca | Trial primary completion date: May 2024 --> Nov 2024

P=N/A, N=60, Recruiting, Jiangsu Healthy Life Innovation Medical Technology Co., Ltd | Not yet recruiting --> Recruiting

P1/2, N=12, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Aug 2025 --> Oct 2024

P2, N=30, Recruiting, Muhammad Furqan | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025

P=N/A, N=1156, Completed, AstraZeneca | Active, not recruiting --> Completed

Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.

The patient continued adjuvant chemotherapy with single-agent durvalumab every 4 weeks and maintained a relapse-free survival of 8 months postoperatively. The utility of durvalumab in combination with gemcitabine plus cisplatin in unresectable gallbladder cancer independent of programmed death ligand-1 expression has been confirmed and may be an important option in future multimodal treatment, including conversion surgery.