Listing a study does not mean it has been evaluated by the U.S. Federal Government. Clin Cancer Res. We conducted a phase II trial of ceralasertib plus durvalumab in patients with previously treated advanced gastric cancer (AGC) to demonstrate the safety, tolerability, and clinical activity of the combination. ataxia telangiectasia and Rad3 related protein (ATR); ceralasertib; durvalumab; immune resistance; melanoma. Talk with your doctor and family members or friends about deciding to join a study. Listing a study does not mean it has been evaluated by the U.S. Federal Government. History of another primary malignancy except for malignancy treated with curative intent with no known active disease 5 years before the first dose of study intervention. A subgroup of patients with a loss of ataxia telangiectasia mutated (ATM) expression and/or high proportion of mutational signature attributable to homologous repair deficiency (sig. Apply to this Phase 2 clinical trial treating Lung Neoplasms, Small Cell Lung Carcinoma, Extensive-stage Small Cell Lung Cancer (SCLC). Some side effects may occur during the injection. Phase 1/2. 2021 Sep 1;27(17):4700-4709. doi: 10.1158/1078-0432.CCR-21-0251. Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy. 2022 Nov 7. doi: 10.1038/s41388-022-02527-z. 10.2217/fon-2020-0737 Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for 3 years. Durvalumab plus ceralasertib demonstrated a promising efficacy signal, with a tolerable safety profile, in patients with advanced/metastatic NSCLC following failure of anti-PD-1/PD-L1-containing immunotherapy and 1 platinum-doublet regimen. Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination. Copyright 2021. Any gastrointestinal condition that would preclude adequate absorption of ceralasertib, including but not limited to inability to swallow oral medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment. Drugs. We do not sell or distribute actual drugs. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061134. (Clinical Trial), A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY, Experimental: Group A: Ceralasertib plus durvalumab combination therapy, Active Comparator: Group B: Docetaxel monotherapy, 18 Years and older (Adult, Older Adult), Contact: AstraZeneca Clinical Study Information Center, Los Angeles, California, United States, 90017, Baltimore, Maryland, United States, 21231, Allentown, Pennsylvania, United States, 18103. complete left bundle branch block , third degree heart block, second degree heart block), Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment. Phase II study of ceralasertib (AZD6738) in combination with durvalumab Careers. NCT03780608. Would you like email updates of new search results? The left panel shows the expression of PD-L1 and ATM, and responses to prior immunotherapy. Ceralasertib Plus Durvalumab Shows Efficacy For PD-1 Inhibitor-Treated The statistical significance was estimated via Wilcoxon rank-sum test. Progression free survival (PFS) [TimeFrame:From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months], Overall Response Rate (ORR) [TimeFrame:up to 12 months], Disease Control Rate (DCR) [TimeFrame:3 months], Clinical Benefit Rate (CBR) [TimeFrame:6 months], Duration of Response (DoR) [TimeFrame:up to 12 months], Overall Survival (OS) [TimeFrame:2, 3, 5 years], Number of adverse events according to CTCAE version 5.0 [TimeFrame:up to 90 days from the last durvalumab administration], ATRiBRAVE trial written informed consent, prior to any study specific procedures. Patients and methods This phase II. AstraZeneca ASCO 2021 data support ambition to revolutionise cancer Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. An official website of the United States government. Ceralasertib (AZD6738) | Available Agents | NCI Formulary P16.07 Immuno-Modulatory Effects of Ceralasertib in Combination with Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. . (F) Box plot of T cell traffic score, one of the Fges, being significantly associated with drug response. Patient must have received at least 1 prior immunotherapy (anti-PD-(L)1 anti-CTLA-4 [Cytotoxic T-lymphocyte-associated protein 4]) for a minimum of 6 weeks and no more than 2 prior regimens in the metastatic setting. Ceralasertib/Durvalumab Combination Stands Out in HUDSON Trial for During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28. 2022 Sep 1;34(5):559-569. doi: 10.1097/CCO.0000000000000867. Li M, Tsavachidis S, Wang F, Bui T, Nguyen TDT, Luo L, Multani AS, Bondy ML, Hunt KK, Keyomarsi K. Oncogene. Future Oncol 2021;17:491501. Breast Cancer - A Phase II, Open-Label, Study of Olaparib in Combination With Either Durvalumab (MEDI4736), Selumetinib or Capivasertib, or Ceralasertib Please enable it to take advantage of the complete set of features! Patients and methods: Bethesda, MD 20894, Web Policies Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. Common adverse events were largely hematologic and manageable with dose interruptions and reductions. This study will consist of two treatment arms (Groups A and B). Phase II study of ceralasertib (AZD6738) in combination with durvalumab in patients with advanced gastric cancer. Among 31 participants, overall, 30 were eligible for this analysis, because one patient (ID16) died from ischemic stroke before response evaluation. Ceralasertib for Lung Cancer Clinical Trial 2022 | Power official website and that any information you provide is encrypted View duration, location, compensation, and staffing details. The study drug schedule was: ceralasertib at 240 mg BD on days 15 to 28 in combination with durvalumab at 1500 mg on day 1 in a 28-day cycle. The researchers reported that the most common grade 3 adverse events with ceralsertib monotherapy were thrombocytopenia in 10% of patients and neutropenia in 20%, both of which resolved with temporary dose interruption or dose reduction. Once the definitive dose for ceralasertib is established, treatment will be continued until progression or unacceptable toxicity, which ever come first. The interval between the last dose of anti-PD-(L)1, BRAF/MEK (B-Rapidly Accelerated Fibrosarcoma gene/mitogen-activated protein kinase gene) inhibitor and the first dose of the study regimen must be a minimum of 14 days. The following are exceptions to this criterion: i) Subjects with vitiligo or alopecia; ii) hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; iii) any chronic skin condition that does not require systemic therapy; iv) patients with coeliac disease controlled by diet alone and patients without active disease in the last 5 years may be included but only after consultation with the study physician. Competing interests: ED, SS, PGSM, A-BL, II-A, and LK are employees and stockholders of AstraZeneca. The Evolving Role of PD-L1 Inhibition in Non-Small Cell Lung Cancer: A Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Ceralasertib at 240 mg administered orally, twice daily on Days -6 to 0 prior to Day 1 Cycle 1 and thereafter on Days 22 to 28 (priming period) of Cycle 1 and every subsequent cycle; Durvalumab at 1500 mg administered via IV infusion on Day 1 of every 28-day cycle; Nab-paclitaxel at 100 mg/m2 administered via IV infusion on Days 1,8 and 15 of every 28- day cycle. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. This phase II trial evaluated ceralasertib plus durvalumab for the treatment of patients with metastatic melanoma (MM) who had failed anti-PD1 therapy. All box plots describe the median and IQR. This phase II trial evaluated ceralasertib plus durvalumab for the treatment of patients with metastatic melanoma who had failed anti-programmed cell death protein 1 therapy. The following intervals between the end of the prior treatment and first dose of study drug must be observed: 4 weeks for radiotherapy (patients who receive palliative radiation for nontarget lesions need not have a 4 week washout period and can be enrolled immediately); patients may receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study; 4 weeks for major surgery; 7 days for minor surgical procedures; 14 days (or 5 half-lives whoever is longest) for any investigational product. Information provided by (Responsible Party): This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Trial registration: As a result of this initial finding, an ongoing study is evaluating combination of ceralasertib with durvalumab in patients with advanced NSCLC following progression on ICI therapy (ClinicalTrials.gov Identifier: NCT03334617). When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Being significantly associated with drug response two treatment arms ( Groups a and B.! This phase 2 clinical trial treating Lung Neoplasms, Small Cell Lung Cancer ( SCLC ) and. 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