Articles with "safety run" as a keyword



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Abstract C100: Safety run-in results from phase 3 study of canakinumab (CAN) or placebo in combination with pembrolizumab (PEM) plus platinum-based doublet chemotherapy (Ctx) as 1stline therapy in patients (pts) with advanced or metastatic NSCLC (CANOPY-1)

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Published in 2019 at "Molecular Cancer Therapeutics"

DOI: 10.1158/1535-7163.targ-19-c100

Abstract: Cytokine interleukin-1β (IL-1β) has multiple pro-tumorogenic effects on tumor microenvironment, thereby promoting carcinogenesis, tumor invasiveness, and immunosuppression. CAN is a selective IL-1β inhibitor that aims to target tumor-promoting inflammation to reduce immune suppression, thereby potentiating… read more here.

Keywords: ctx; pem; safety run; combination ... See more keywords
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Comparison of design methods for a safety run-in phase of a phase II clinical trial

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Published in 2023 at "Clinical Trials"

DOI: 10.1177/17407745221140913

Abstract: Background/Aims: In pediatric oncology, a Phase II trial often utilizes a safety run-in phase followed by an efficacy phase that enrolls at the dose level selected based on the safety run-in. Different from a Phase… read more here.

Keywords: safety; design; safety run; phase ... See more keywords
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Initial safety run-in findings with bavituximab plus pembrolizumab in patients with advanced gastric or gastroesophageal cancer.

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Published in 2020 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2020.38.15_suppl.e16537

Abstract: e16537Background: Bavituximab, an investigational, chimeric monoclonal antibody designed to inhibit the immunosuppressive effects of phosphatidylserine (PS), is being evaluated in combination with ... read more here.

Keywords: findings bavituximab; plus pembrolizumab; run findings; bavituximab plus ... See more keywords
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A phase II/III study of perioperative nivolumab and ipilimumab in patients (pts) with locoregional esophageal (E) and gastroesophageal junction (GEJ) adenocarcinoma: Results of a safety run-in—A trial of the ECOG-ACRIN Cancer Research Group (EA2174).

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Published in 2021 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2021.39.15_suppl.4064

Abstract: 4064 Background: E/GEJ adenocarcinoma has a high mortality rate despite curative intent therapy. The use of immune checkpoint inhibition is beneficial for treatment of this cancer in the metastatic and adjuvant settings but the role… read more here.

Keywords: safety run; arm; gej adenocarcinoma; trial ... See more keywords
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Safety of FOLFIRI + Durvalumab +/− Tremelimumab in Second Line of Patients with Advanced Gastric Cancer: A Safety Run-In from the Randomized Phase II Study DURIGAST PRODIGE 59

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Published in 2022 at "Biomedicines"

DOI: 10.3390/biomedicines10051211

Abstract: Efficacy of immune checkpoint inhibitors (ICI) as monotherapy in 2nd line treatment for gastric or gastro-oesophageal junction (GEJ) adenocarcinoma is low, with no evaluation of efficacy and safety of ICI combined with chemotherapy. The DURIGAST… read more here.

Keywords: safety; safety run; phase; folfiri durvalumab ... See more keywords