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)
Sign Up to like & getrecommendations! 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
Abstract PO1-06-09: Phase 2 Trial with Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast CancersBig Ten Cancer Research Consortium BTCRC-BRE18-337
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DOI: 10.1158/1538-7445.sabcs23-po1-06-09
Abstract: Up to 2/3 of triple negative breast cancers (TNBC) have acquired defects in homologous recombination (HR) DNA repair, yet poly (ADP-ribose) polymerase inhibitor (PARPi) monotherapy has been largely ineffective in the absence of a germline… read more here.
Keywords: cancer; breast; safety run; mutation ... See more keywords
Comparison of design methods for a safety run-in phase of a phase II clinical trial
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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
Initial safety run-in findings with bavituximab plus pembrolizumab in patients with advanced gastric or gastroesophageal cancer.
Sign Up to like & getrecommendations! 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
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).
Sign Up to like & getrecommendations! 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
GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab.
Sign Up to like & getrecommendations! Published in 2025 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2025.43.4_suppl.730
Abstract: 730 Background: Immunotherapies are effective in only the small subset of metastatic PDAC patients with MSI-H or dMMR tumors. Pelareorep (pela) is a non-genetically modified, intravenously administered reovirus that selectively infects cancer cells. It stimulates… read more here.
Keywords: cohort; study; safety run; pela ... See more keywords
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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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