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Journal articles on the topic 'Weak key-IV combinations'

Author: Grafiati

Published: 11 December 2022

Last updated: 31 July 2025

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1

Roy Choudhury, Shouvik, and Teppei Okumura. "Updated Cosmological Constraints in Extended Parameter Space with Planck PR4, DESI Baryon Acoustic Oscillations, and Supernovae: Dynamical Dark Energy, Neutrino Masses, Lensing Anomaly, and the Hubble Tension." Astrophysical Journal Letters 976, no. 1 (2024): L11. http://dx.doi.org/10.3847/2041-8213/ad8c26.

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Abstract We present updated constraints on cosmological parameters in a 12-parameter model, extending the standard six-parameter ΛCDM by including dynamical dark energy (DE; w 0, w a ), the sum of neutrino masses (∑m ν ), the effective number of non-photon radiation species (N eff), the lensing amplitude scaling (A lens), and the running of the scalar spectral index (α s ). For cosmic wave background (CMB) data, we use the Planck Public Release (PR) 4 (2020) HiLLiPoP and LoLLiPoP likelihoods, Planck PR4+Atacama Cosmology Telescope (ACT) DR6 lensing, and Planck 2018 low-ℓ TT likelihoods, along

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Rugo, H. S., M. Campone, D. Amadori, et al. "Randomized phase II study of weekly versus every-3-week ixabepilone plus bevacizumab (ixa/bev) versus paclitaxel plus bev (pac/bev) as first-line therapy for metastatic breast cancer (MBC)." Journal of Clinical Oncology 27, no. 15_suppl (2009): 1029. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.1029.

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1029 Background: Pac/bev is superior to pac alone as first-line therapy for MBC. Ixa/bev has greater preclinical activity than pac/bev in human tumor models. The primary objective of this trial was to evaluate objective response rates (ORR) of ixa/bev given weekly or every 3 weeks relative to pac/bev as 1st line therapy for women with advanced breast cancer. Methods: Women with measurable disease and no prior chemotherapy for advanced breast cancer (locally advanced or MBC) were randomized in a 3:3:2 ratio to Arm A (ixa 16 mg/m2 IV on days 1, 8 & 15 q28 days/ bev 10 mg/kg IV q 2 wks), Arm

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Sands, B. E., B. G. Feagan, W. J. Sandborn, et al. "OP36 Efficacy and safety of combination induction therapy with guselkumab and golimumab in participants with moderately-to-severely active Ulcerative Colitis: Results through week 12 of a phase 2a randomized, double-blind, active-controlled, parallel-group, multicenter, proof-of-concept study." Journal of Crohn's and Colitis 16, Supplement_1 (2022): i042—i043. http://dx.doi.org/10.1093/ecco-jcc/jjab232.035.

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Abstract Background Preclinical data from a murine model of acute colitis suggest that dual blockade of interleukin(IL)-23 and TNFα more effectively prevented the development of colonic inflammation than each monotherapy. Guselkumab(GUS), an IL-23p19 subunit antagonist, is being studied in inflammatory bowel disease. Golimumab(GOL), a TNFα antagonist, is approved for ulcerative colitis(UC). The objective of this study was to evaluate the efficacy and safety of combination induction therapy with GUS+GOL vs GUS or GOL alone in adults with moderately-to-severely active UC. Methods 214 patients(pt

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Mizutani, Teruyuki, Amrutesh Puranik, Tomoaki Muramatsu, et al. "Abstract 5922: B cell subtype is a predictive and pharmacodynamic biomarkers for combination therapy in stage III-IV melanoma: a simon phase II trial." Cancer Research 85, no. 8_Supplement_1 (2025): 5922. https://doi.org/10.1158/1538-7445.am2025-5922.

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Background: Assessing biomarkers to predict immune-related adverse events (irAEs) is crucial for optimizing melanoma treatment with immune checkpoint inhibitors (ICIs). T and B lymphocytes are key mediators of autoimmunity and are implicated in the development of irAEs. Here we focus on analysis of specific B cell subsets, as predictive and pharmacodynamic biomarkers for irAEs in a phase II trial combining nivolumab (3 mg/kg), ipilimumab(1 mg/ml), and the IL-6 receptor inhibitor tocilizumab (4 mg/kg) in unresectable/advanced stage III/IV melanoma patients. Methods: We analyzed cryopreserved PB

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Chesney, Jason A., Igor Puzanov, Frances A. Collichio, et al. "Talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone for advanced melanoma: 5-year final analysis of a multicenter, randomized, open-label, phase II trial." Journal for ImmunoTherapy of Cancer 11, no. 5 (2023): e006270. http://dx.doi.org/10.1136/jitc-2022-006270.

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Talimogene laherparepvec (T-VEC) plus ipilimumab has demonstrated greater antitumor activity versus ipilimumab alone, without additional toxicity, in patients with advanced melanoma. Here, we report the 5-year outcomes from a randomized phase II study. These data provide the longest efficacy and safety follow-up for patients with melanoma treated with a combination of an oncolytic virus and a checkpoint inhibitor.Eligible patients with unresectable stage IIIB‒IV melanoma were randomized 1:1 to receive T-VEC plus ipilimumab or ipilimumab alone. T-VEC was administered intralesionally at 106plaqu

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Kubota, Kaoru, Hiroshige Yoshioka, Fumihiro Oshita, et al. "Phase III, Randomized, Placebo-Controlled, Double-Blind Trial of Motesanib (AMG-706) in Combination With Paclitaxel and Carboplatin in East Asian Patients With Advanced Nonsquamous Non–Small-Cell Lung Cancer." Journal of Clinical Oncology 35, no. 32 (2017): 3662–70. http://dx.doi.org/10.1200/jco.2017.72.7297.

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Purpose This phase III, randomized, placebo-controlled, double-blind study determined whether motesanib improved progression-free survival (PFS) compared with placebo in combination with paclitaxel and carboplatin (P/C) in East Asian patients with stage IV/recurrent nonsquamous non–small-cell lung cancer. Patients and Methods Patients were randomly assigned (1:1) to receive oral motesanib 125 mg or placebo once daily plus paclitaxel 200 mg/m2 IV and carboplatin area under the concentration-time curve 6 mg/mL ⋅ min IV for up to six 3-week cycles. Random assignment was stratified by epidermal gr

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Xi, Jing, Jingqing Luo, Ciara O’Sullivan, et al. "SYST-13 PHASE II STUDY OF THE COMBINATION OF LIPOSOMAL IRINOTECAN AND PEMBROLIZUMAB FOR TRIPLE-NEGATIVE BREAST CANCER (TNBC) WITH BRAIN METASTASES (BM)." Neuro-Oncology Advances 4, Supplement_1 (2022): i24. http://dx.doi.org/10.1093/noajnl/vdac078.092.

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Abstract BACKGROUND Breast cancer is one of the most common cancers associated with brain metastases (BM). Up to 50% of patients with metastatic triple-negative breast cancer (TNBC) develop BM which portends a poor prognosis, with a median survival of 4.4-7.3 months. There is a lack of effective systemic therapy. Irinotecan is a topoisomerase-1 inhibitor with a response rate of 5-23% in advanced breast cancer. Nal-IRI is an intravenous liposomal formulation of irinotecan, with greater efficacy in tumor growth inhibition and the ability to cross the blood brain barrier (BBB) than irinotecan, re

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Kus, Julianne V., John Kelly, Luc Tessier, Hanjeong Harvey, Dennis G. Cvitkovitch, and Lori L. Burrows. "Modification of Pseudomonas aeruginosa Pa5196 Type IV Pilins at Multiple Sites with d-Araf by a Novel GT-C Family Arabinosyltransferase, TfpW." Journal of Bacteriology 190, no. 22 (2008): 7464–78. http://dx.doi.org/10.1128/jb.01075-08.

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ABSTRACT Pseudomonas aeruginosa Pa5196 produces type IV pilins modified with unusual α1,5-linked d-arabinofuranose (α1,5-d-Araf) glycans, identical to those in the lipoarabinomannan and arabinogalactan cell wall polymers from Mycobacterium spp. In this work, we identify a second strain of P. aeruginosa, PA7, capable of expressing arabinosylated pilins and use a combination of site-directed mutagenesis, electrospray ionization mass spectrometry (MS), and electron transfer dissociation MS to identify the exact sites and extent of pilin modification in strain Pa5196. Unlike previously characteriz

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Hammel, Pascal, Rossana Berardi, Geert-Yan Creemers, et al. "TRYbeCA-1: A randomized, phase III study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)." Journal of Clinical Oncology 38, no. 15_suppl (2020): TPS4666. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.tps4666.

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TPS4666 Background: Second-line treatment options for advanced pancreatic adenocarcinoma are currently limited. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. We have recently reported the outcome of a randomized Phase 2b study inpatients with advanced pancreatic cancer whose disease progressed following first-line treatment(NCT02195180). Eryaspase in combination with gemcitabine monothera

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Hammel, Pascal, Rossana Berardi, Eric Van Cutsem, et al. "TRYbeCA-1: A randomized, phase III study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)." Journal of Clinical Oncology 38, no. 4_suppl (2020): TPS783. http://dx.doi.org/10.1200/jco.2020.38.4_suppl.tps783.

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TPS783 Background: Second-line treatment options for advanced pancreatic adenocarcinoma are currently limited. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. We have recently reported the outcome of a randomized Phase 2b study inpatients with advanced pancreatic cancer whose disease progressed following first-line treatment. Eryaspase in combination with gemcitabine monotherapy or FOLFOX c

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Hammel, Pascal, Rossana Berardi, Eric Van Cutsem, et al. "Trybeca-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)." Journal of Clinical Oncology 37, no. 4_suppl (2019): TPS471. http://dx.doi.org/10.1200/jco.2019.37.4_suppl.tps471.

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TPS471 Background: Second-line treatment options for advanced pancreatic adenocarcinoma are currently limited. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. We have recently reported the outcome of a randomized Phase 2b study inpatients with advanced pancreatic cancer whose disease progressed following first-line treatment(NCT02195180). Eryaspase in combination with gemcitabine monotherap

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García-García, Carlos, David Alonso, Pedro G. Ferreira, et al. "Combining cosmic shear data with correlated photo-z uncertainties: constraints from DESY1 and HSC-DR1." Journal of Cosmology and Astroparticle Physics 2023, no. 01 (2023): 025. http://dx.doi.org/10.1088/1475-7516/2023/01/025.

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Abstract An accurate calibration of the source redshift distribution p(z) is a key aspect in the analysis of cosmic shear data. This, one way or another, requires the use of spectroscopic or high-quality photometric samples. However, the difficulty to obtain colour-complete spectroscopic samples matching the depth of weak lensing catalogs means that the analyses of different cosmic shear datasets often use the same samples for redshift calibration. This introduces a source of statistical and systematic uncertainty that is highly correlated across different weak lensing datasets, and which must

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Yacoub, Abdulraheem, Tara L. Lin, Heather J. Male, et al. "Pilot Phase II Trial of the Combination of Tagraxofusp with Pacritinib in Patients with Myelofibrosis, Tagpac Study." Blood 144, Supplement 1 (2024): 6641. https://doi.org/10.1182/blood-2024-194439.

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Background: Myelofibrosis (MF) is a chronic myeloid malignancy characterized by a variable presentation of symptom burden, splenomegaly, cytopenias and increased risk of mortality and transformation to acute leukemia. Therapy with JAK inhibitors was developed based on the discovery and characterization of the biological driver role of the overactive JAK-STAT signaling in the pathophysiology of MF. Multiple JAK inhibitors have been approved for MF based on activity in spleen volume reduction, symptoms improvement, and additional clinical benefits that are unique to each agent. None of the appro

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Arance Fernandez, ANA Maria, Paolo Antonio Ascierto, Matteo S. Carlino, et al. "Lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with advanced melanoma previously exposed to anti–PD-1/PD-L1 agents: Phase 2 LEAP-004 study." Journal of Clinical Oncology 37, no. 15_suppl (2019): TPS9594. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps9594.

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TPS9594 Background: Pembro, a PD-1 inhibitor, has shown effective antitumor activity, deep and durable responses, and survival benefit in treatment-naive pts and those with previously treated metastatic melanoma. Len, a potent inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor α, RET, and KIT, combined with a PD-1 inhibitor showed antitumor activity superior to either agent alone in preclinical models of colorectal and lung cancer. Additionally, len plus pembro showed anti-tumor activity and was well-tolerated (24-wk ORR, 47.6%; TRAE: gr 3/4, 67%; gr 5, 0%) in pts with advanced

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Puzanov, Igor, Jason Chesney, Frances Collichio, et al. "433 Talimogene laherparepvec (T-VEC) in combination with ipilimumab (IPI) versus IPI alone for advanced melanoma: 4-year interim analysis of a randomized, open-label, phase 2 trial." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (2020): A459. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0433.

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BackgroundThis is the first randomized trial evaluating an oncolytic virus with an immune checkpoint inhibitor in advanced melanoma. Improved objective response rate (ORR) was observed for T-VEC plus IPI compared to IPI alone (39% vs. 18%; OR 2.9; 95% Cl, 1.5–5.5; P=0.002).1 At 3-year follow-up, median OS was not reached in either arm (HR, 0.85; 95% CI, 0.55–1.32; P=0.480).2 Here we present 4-year interim analysis results including BRAF V600 mutation subgroup analysis.MethodsPatients with unresectable or metastatic (IIIB-IV) melanoma were randomized 1:1 to receive T-VEC plus IPI or IPI alone.

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Schwartz, Rayna L., Claudia Espitia, Dan O. Persky, Steffan T. Nawrocki, and Jennifer S. Carew. "The Clinical Oncolytic Reovirus Formulation Reolysin Synergistically Augments the Anti-Leukemic Activity of Azacitidine." Blood 138, Supplement 1 (2021): 3337. http://dx.doi.org/10.1182/blood-2021-151575.

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Abstract Despite the recent development of new agents for acute myeloid leukemia (AML) therapy, novel approaches are still needed for patients that do not benefit sufficiently from existing regimens. Reolysin (Pelareorep) is a proprietary clinical formulation of the naturally occurring oncolytic reovirus that is non-pathogenic and preferentially replicates in cancer cells, but not in normal tissue. Although Reolysin has been investigated in over 30 adult clinical trials and is very well tolerated when given alone and in combination with chemotherapy, it has never been evaluated for AML therapy

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Burris III, Howard A., Susanna Varkey Ulahannan, Eric B. Haura, et al. "The bi-steric mTORC1-selective inhibitor RMC-5552 in tumors with activation of mTOR signaling: Preclinical activity in combination with RAS(ON) inhibitors in RAS-addicted tumors, and initial clinical findings from a single agent phase 1/1b study." Journal of Clinical Oncology 40, no. 16_suppl (2022): 3098. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.3098.

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3098 Background: RMC-5552 is a potent bi-steric mTORC1-selective inhibitor that activates the downstream tumor suppressor 4EBP1, thereby inhibiting initiation of protein translation. This novel therapeutic moiety addresses a key limitation of rapalogs, which do not effectively inhibit phosphorylation of 4EBP1. RMC-5552 has previously demonstrated significant anti-tumor activity in preclinical models of human cancers with mTOR pathway activation. Additionally, mTOR signaling plays a key role in therapeutic response and resistance in RAS-addicted cancers, which represent a significant unmet medi

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Burris III, Howard A., Susanna Varkey Ulahannan, Eric B. Haura, et al. "The bi-steric mTORC1-selective inhibitor RMC-5552 in tumors with activation of mTOR signaling: Preclinical activity in combination with RAS(ON) inhibitors in RAS-addicted tumors, and initial clinical findings from a single agent phase 1/1b study." Journal of Clinical Oncology 40, no. 16_suppl (2022): 3098. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.3098.

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3098 Background: RMC-5552 is a potent bi-steric mTORC1-selective inhibitor that activates the downstream tumor suppressor 4EBP1, thereby inhibiting initiation of protein translation. This novel therapeutic moiety addresses a key limitation of rapalogs, which do not effectively inhibit phosphorylation of 4EBP1. RMC-5552 has previously demonstrated significant anti-tumor activity in preclinical models of human cancers with mTOR pathway activation. Additionally, mTOR signaling plays a key role in therapeutic response and resistance in RAS-addicted cancers, which represent a significant unmet medi

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Goss, Glenwood D., Christian Manegold, Rafael Rosell, et al. "The GALAXY Trial(NCT01348126): A randomized IIB/III study of ganetespib (STA-9090) in combination with docetaxel versus docetaxel alone in subjects with stage IIIB or IV NSCLC." Journal of Clinical Oncology 30, no. 15_suppl (2012): TPS7613. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.tps7613.

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TPS7613^ Background: Hsp90 is a molecular chaperone required for proper folding and activation of many cancer-promoting proteins and is recognized as a key facilitator of cancer cell growth and survival. In pre-clinical models, Hsp90 inhibition causes degradation of multiple client proteins and leads to cancer cell death. Ganetespib is a resorcinolic Hsp90 inhibitor that has shown potent anti-tumor activity in patients with lung, breast, and other cancers that had progressed on standard treatment agents. Moreover, combination of ganetespib with docetaxel results in synergistic antiproliferativ

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Ahn, Yuran, Jaehyuk Jang, Seonghyeon Bu, Nay Aung, Hyo-Suk Ahn, and Keun-Sang Yum. "Study Design and Rationale of a Randomized Trial Comparing Aspirin–Sarpogrelate Combination Therapy with Aspirin Monotherapy: Effects on Blood Viscosity and Microcirculation in Cardiovascular Patients." Diagnostics 15, no. 11 (2025): 1373. https://doi.org/10.3390/diagnostics15111373.

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Coronary artery disease (CAD) and peripheral artery disease (PAD) are associated with increased blood viscosity, which contributes to vascular inflammation and impaired microcirculation. Blood viscosity plays a crucial role in disease progression, influencing endothelial function and tissue perfusion. Sarpogrelate hydrochloride, a serotonin receptor antagonist, has antiplatelet and vasodilatory properties that may improve microvascular function and blood rheology. This randomized, parallel-group, open-label, single-center, phase IV clinical trial enrolled 68 patients with both CAD and PAD. The

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Stanciu, Silviu, Alexandru Burcin, Diana Iancu, Maria Magdalena Gurzun, Alexandru Croitoru, and Lucian Ciobîcă. "Prosthetic Heart Valves Thrombosis with Infectious Endocarditis - A Practical Review." Internal Medicine 17, no. 6 (2020): 55–64. http://dx.doi.org/10.2478/inmed-2020-0143.

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Abstract Simultaneous or sequential combination of prosthetic valve (PV) thrombosis and infectious endocarditis is a rare clinical finding. The management of these patients involves a complex multidisciplinary strategy using clinical judgment and imaging techniques. Transesophageal echocardiography (TEE) and especially 3D transesophageal echocardiography is essential. Moreover, positron emission tomography with fluorodeoxyglucose (F18-FDG PET/CT) can be a valuable tool to diagnose and manage these complicated clinical scenarios. We present the case of a 65-year-old patient who was admitted in

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Azzoli, C. G., L. Krug, V. Miller, et al. "Phase I study of the antifolate pralatrexate given with vitamin B12 and folic acid supplementation in patients (pts) with advanced non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 25, no. 18_suppl (2007): 13006. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.13006.

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13006 Background: Pralatrexate is a novel antifolate that has shown promising activity in the treatment of pts with previously- treated NSCLC at doses of 135–150 mg/m2 IV every other week (q2w). [Krug, Clin Cancer Res 9(6), 2003; 6(9), 2000] The addition of vitamin B12 and folic acid supplementation may mitigate toxicity from pralatrexate and improve efficacy by allowing higher doses to be delivered. Methods: This study is designed to determine the maximum tolerated dose (MTD) of pralatrexate in combination with vitamin B12 and folic acid supplementation in pts with NSCLC. Key eligibility crit

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Mariette, X., C. Baldini, F. Barone, et al. "OP0135 SAFETY AND EFFICACY OF SUBCUTANEOUS BELIMUMAB AND INTRAVENOUS RITUXIMAB COMBINATION IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME: A PHASE 2, RANDOMISED, PLACEBO-CONTROLLED 68-WEEK STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 78.2–79. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2170.

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Background:B-lymphocyte stimulator (BLyS) is increased in primary Sjögren’s syndrome (pSS) and plays a role in the B-cell hyperactivity thought to contribute to pSS. Belimumab (BEL, anti-BLyS) and rituximab (RTX, anti-CD20) target B cells through distinct and potentially complementary mechanisms.Objectives:To evaluate the safety and efficacy of subcutaneous (SC) BEL/intravenous (IV) RTX combination (BEL/RTX) in patients with pSS.Methods:This Phase 2, double-blind study (GSK Study 201842; NCT02631538) randomised 86 adults with active pSS to 4 treatment arms stratified for baseline EULAR Sjögren

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Foxton, Caroline, Bart Cornelissen, Edward O'Neill, et al. "Abstract 694: Evaluation of a synergistic drug combination with 177Lu-rhPSMA-10.1 for prostate cancer: Results of an in vitro screen and in vivo proof of concept study." Cancer Research 84, no. 6_Supplement (2024): 694. http://dx.doi.org/10.1158/1538-7445.am2024-694.

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Abstract Purpose: Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) has been shown to extend survival in men with advanced prostate cancer (PCa). Novel radiohybrid (rh) PSMA-targeted 177Lu-rhPSMA-10.1 has shown promising preclinical efficacy and advantageous radiation dosimetry in humans. We conducted an in vitro screen to identify known anticancer drugs with potential for synergistic interaction with 177Lu-rhPSMA-10.1. Here we present key screening data and a subsequent in vivo efficacy analysis of the lead novel drug combination in PSMA-expressing 22Rv1 PCa xenogra

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Campbell, Matthew T., Tian Zhang, Lynda Chin, Allison Betof Warner, and Matthen Mathew. "ApricityRx companion digital therapeutic for evidence-based mitigation and phenotype-linked molecular characterization of irAEs in patients receiving immune checkpoint therapy (ICT)." Journal of Clinical Oncology 38, no. 15_suppl (2020): TPS2089. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.tps2089.

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TPS2089 Background: Presentation of immune-related adverse events (irAEs) is heterogeneous and unpredictable in patients receiving immune checkpoint therapy (ICT). ICT has been approved for cancer patients as single agent, combination of dual ICT, ICT plus chemotherapy, and ICT plus targeted therapy. Given the ever increasing complexity in recognizing and managing irAEs, coupled with the lack of skilled resources and clinical experience in real world practice, there is increasing demand for digital solutions that can detect early toxicity and support evidence-based interventions in real world

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Zeiser, Robert, Hannah Choe, Holger Adelmann, et al. "Safety and Efficacy of the Glucagon-like Peptide 2 (GLP-2) Analog Apraglutide in Patients with Steroid-Refractory Gastrointestinal Acute Graft-Versus-Host Disease (aGvHD) in Combination with Best Available Therapy: Results from a Multicenter, Randomized, Single-Blind, Proof-of-Concept, Phase 2 Stargaze Trial." Blood 144, Supplement 1 (2024): 100. https://doi.org/10.1182/blood-2024-198360.

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Introduction:Acute graft-versus-host disease (aGvHD) is a severe and life-threatening condition that often develops after allogeneic hematopoietic cell transplantation (alloHCT). Approximately 50% of patients (pts) who receive systemic glucocorticoids (GCs) as first-line treatment do not achieve an adequate and durable response and become steroid refractory (SR). Among pts with grade II-IV aGvHD, ~70% have gastrointestinal (GI) involvement, a key driver of morbidity and mortality. GI aGvHD is often steroid-refractory, and despite recent improvements with the availability of ruxolitinib (RUX) a

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Wendtner, Clemens-Martin, John C. Byrd, Robin Foà, et al. "COSMOS: MOR208 plus idelalisib or venetoclax in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton's tyrosine kinase inhibitor (BTKi)—A two-cohort phase II study." Journal of Clinical Oncology 35, no. 15_suppl (2017): TPS7567. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.tps7567.

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TPS7567 Background: Patients (pts) with R/R CLL who discontinue treatment with the BTKi ibrutinib due to progression have a particularly dismal prognosis. A phase I study showed that the Fc-enhanced, humanized, CD19 antibody MOR208 was well tolerated with encouraging single-agent activity in pts with R/R CLL/SLL. In preclinical models, MOR208 showed synergy with idelalisib (an inhibitor of PI3K delta) and venetoclax (an inhibitor of BCL-2), both approved for the treatment of CLL. Methods: This two-cohort, phase II study will investigate MOR208 combined with idelalisib (cohort A) or venetoclax

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Lee, Michael Sangmin, Patrick J. Loehrer, Iman Imanirad, et al. "Phase II study of ipilimumab, nivolumab, and panitumumab in patients with KRAS/NRAS/BRAF wild-type (WT) microsatellite stable (MSS) metastatic colorectal cancer (mCRC)." Journal of Clinical Oncology 39, no. 3_suppl (2021): 7. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.7.

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7 Background: Panitumumab is a monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR) and is a standard therapy in KRAS/NRAS/BRAF WT mCRC. Preclinical data shows that anti-EGFR therapy causes a tumor-specific adaptive immune response and immunogenic apoptosis, with functional adaptive immunity required to mediate efficacy. However, resistance to anti-EGFR antibody therapy inevitably develops and is associated with increased expression of CTLA-4 and PD-L1. We hypothesized that addition of ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) to panitumumab will increase re

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Rymarenko, N. V., and T. A. Achkasova. "Antiviral therapy in patients with chronic hepatitis D and decompensated cirrhosis on liver transplant waiting list." Infekcionnye bolezni 22, no. 4 (2024): 32–41. https://doi.org/10.20953/1729-9225-2024-4-32-41.

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Objective. To analyse the results of using bulevirtide, HBV/HDV entry inhibitor, in patients with chronic hepatitis D (CHD) at the stage of decompensated cirrhosis. Patients and methods. Bulevirtide monotherapy was performed in 3 patients with decompensated cirrhosis Child-Pugh B and C on the liver transplant waiting list, as well as in 1 patient with decompensation during treatment due to the progressive course of a cholangiocarcinoma. The observation period was 24 and 36 weeks, respectively. Results. All patients with decompensated cirrhosis achieved virological response at week 24 (includin

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Dunne, Richard Francis, Nicholas A. Ullman, Brian A. Belt, et al. "A phase I study to evaluate the safety and tolerability of SX-682 in combination with PD-1 inhibitor as maintenance therapy for unresectable pancreatic adenocarcinoma." Journal of Clinical Oncology 40, no. 4_suppl (2022): TPS631. http://dx.doi.org/10.1200/jco.2022.40.4_suppl.tps631.

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TPS631 Background: Survival outcomes for advanced pancreatic ductal adenocarcinoma (PDAC) remain dismal despite improvements in systemic therapy regimens developed over the past decade. In addition, current first-line therapies result in cumulative cytopenias and neuropathy, highlighting the need for more effective, less toxic maintenance treatment strategies. There are currently no standard approved maintenance treatments for patients with PDAC not associated with BRCA or DNA-repair mutations. Pre-clinical data suggest a potential synergistic effect of combining blockade of CXC chemokine rece

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Song, Yuqin, Jun Zhu, Ningjing Lin, et al. "A phase I/II study of the anti-programmed cell death-1 (PD-1) antibody AK105 in patients with relapsed or refractory classic Hodgkin lymphoma (cHL)." Journal of Clinical Oncology 37, no. 15_suppl (2019): e19017-e19017. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e19017.

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e19017 Background: AK105 is a humanized IgG1 mAb that blocks PD-1 binding to PD-L1 allowing T-cells to recognize and kill tumor cells. Key attributes of AK105 include antibody engineering to eliminate Fc mediated effector function, and a slower off-rate on antigen binding resulting in improved receptor occupancy. These features were designed to offer more robust biological effect and enhance anti-tumor activity of AK105. Methods: A multicenter, Phase I/II, single-arm study in relapsed/refractory cHL (NCT03722147) began in July, 2018, evaluating the safety and efficacy of AK105 administered IV

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Hammel, Pascal, Iman El-Hariry, Teresa Macarulla, et al. "Trybeca-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with advanced pancreatic adenocarcinoma (NCT03665441)." Journal of Clinical Oncology 40, no. 4_suppl (2022): 518. http://dx.doi.org/10.1200/jco.2022.40.4_suppl.518.

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518 Background: Eryaspase, asparaginase encapsulated in red blood cells is an investigational product under development. The encapsulated asparaginase induces the degradation of asparagine and glutamine, crucial for cancer cell growth and survival. An earlier Phase 2b study in patients with advanced pancreatic cancer showed an improvement in overall survival (OS) and progression free survival (PFS) with eryaspase plus chemotherapy. Methods: TRYbeCA-1 was a randomized, open-label Phase 3 trial of eryaspase combined with chemotherapy in patients with advanced adenocarcinoma of the pancreas who h

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Modi, Dipenkumar, Jay Yang, Seongho Kim, et al. "An Investigator Initiated Study of RCHOP in Combination with Selinexor (KPT-330) in Diffuse Large B Cell Lymphoma and Richter Transformation." Blood 144, Supplement 1 (2024): 3123.4. https://doi.org/10.1182/blood-2024-209059.

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Background and Significance: Rituximab-containing chemoimmunotherapy remains standard front-line treatment for newly diagnosed diffuse large B cell lymphoma (DLBCL) including Richter transformation (RT). Approximately 70% of patients with DLBCL achieve durable remission with this approach. Patients with RT, however, frequently experience shorter remissions. Therefore, novel strategies are warranted to improve outcomes of these patients. Selinexor is a first in class, slowly reversible, potent and selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1) a

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Lacy, M., M. Alsina, C. L. Melvin, et al. "Phase 1 first-in-human dose escalation study of cp-751,871, a specific monoclonal antibody against the insulin like growth factor 1 receptor." Journal of Clinical Oncology 24, no. 18_suppl (2006): 7609. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.7609.

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7609 Background: Multiple lines of evidence indicate that the Insulin Like Growth Factor 1 Receptor (IGF-1R) plays a key role in the progression of multiple myeloma (MM). IGF-1 is a growth factor for MM cells. It promotes survival to the cytotoxic effects of chemotherapy in animal models of MM and its blood levels has been shown to correlate with those of paraprotein in MM patients. CP-751,871, a fully human monoclonal antibody, is a highly specific and potent inhibitor of the autophosphorylation of IGF-1R. Methods: Based on its mechanism of action and the potential relevance of IGF-1R in MM,

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Rutkowski, Piotr, Dariusz Kowalski, Victor Moreno, et al. "A phase 1 study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), and to determine the recommended phase 2 dose (RP2D) of subcutaneous (SC) cetrelimab (CET) in patients (pts) with advanced solid malignancies." Journal of Clinical Oncology 42, no. 16_suppl (2024): e14602-e14602. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e14602.

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e14602 Background: In part (P) 1 and P2 of LUC1001 (NCT02908906), the RP2D of intravenous (IV) CET was established as 240 mg IV once every 2 weeks (Q2W) or 480 mg IV Q4W, and the PK/PD characteristics, safety profile, and clinical activity were consistent with known and approved PD-1 inhibitors (Felip et al. Cancer Chemother Pharmacol 2022). CET administered SC was investigated in P3 and P4 of LUC1001. Methods: In P3 and P4 of LUC1001, safety, PK, PD, and clinical activity of low- (30 mg/mL [CET-LC]) and high- (150 mg/mL [CET-HC]) concentration SC CET formulations, respectively, were evaluated

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Flood, W. A., and L. D. Lewis. "A phase I study of intravenous (IV) milataxel in combination with carboplatin in adult patients with advanced malignant solid tumors." Journal of Clinical Oncology 27, no. 15_suppl (2009): e13525-e13525. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e13525.

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e13525 Background: Milataxel (MXL) is a novel taxane with activity in human xenograft models against tumors resistant to paclitaxel. The primary objective of this study was to determine the MTD when MXL was given intravenously in combination with a fixed dose (AUC=6) of carboplatin (C) every 21 days in subjects with advanced malignant solid tumors. Secondary objectives were to (i) assess the safety and tolerability of the combination (ii) define the pharmacokinetics of MXL and C when given in combination (iii) obtain preliminary information on the antitumor activity of MXL+C. Methods: Key subj

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Odia, Yazmin, Ludimila Cavalcante, Howard Safran та ін. "Malignant glioma subset from Actuate 1801: A phase 1/2 study of 9-ING-41, a glycogen synthase kinase 3 beta (GSK-3β) inhibitor, as a single agent and combined with chemotherapy, in patients with refractory hematologic malignancies or solid tumors." Journal of Clinical Oncology 39, № 15_suppl (2021): 2051. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.2051.

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2051 Background: GSK-3β, a serine/threonine kinase, is a key regulator of metabolism and glycogen biosynthesis. GSK-3β aberrant overexpression promotes tumor progression and chemotherapy resistance through NF-κB and p53-mediated apoptotic pathways. GSK-3β inhibition impacts immunomodulation through downregulation of checkpoints, such as PD-L1 and LAG-3, and increasing NK and T-cell mediated killing of tumor cells. 9-ING-41 is a small-molecule potent selective GSK-3β inhibitor with preclinical antitumor activity against several tumor types. In chemoresistant PDX models of glioblastoma (GBM), 9-

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Brusak, Vitaliy, Ihor Gnatiak, and Viktoria Shtuhlynets. "STATE AND MONITORING OF CARPATIAN NATIONAL PARK TOURIST ROUTES’ MICRORELIEF." PROBLEMS OF GEOMORPHOLOGY AND PALEOGEOGRAPHY OF THE UKRANIAN CARPATHIANS AND ADJACENT AREAS, no. 15 (September 25, 2023): 30–47. http://dx.doi.org/10.30970/gpc.2023.1.3946.

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Recreation is one of the anthropogenic factors of negative impact on the natural environment of the Ukrainian Carpathians and, above all, on the natural complexes of the national parks of the region. In this regard, the Carpathian NPP with a developed recreational infrastructure – a network of tourist routes and stationary recreation areas is an indicative example. Excessive recreational load causes recreational digression and activation of erosion processes on tourist routes. It was established that different tourist routes have different general state of recreational digression and different

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Menon, Nandini Sharrel, Vanita Noronha, Amit Joshi, et al. "Quality of life in patients with locally advanced head and neck cancer undergoing chemoradiation with once-a-week versus once-every-three-weeks cisplatin." Journal of Clinical Oncology 38, no. 15_suppl (2020): 12092. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.12092.

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12092 Background: This trial was conducted to compare the efficacy of low dose once-a-week cisplatin with once-every-3-weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial. Methods: In this phase III randomized trial, patients with stage III or IV non-metastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once a week or cisplatin 100 mg/m2 once every 3 weeks concurrently with curative intent radiotherapy. The primary endpoint was locoregional control. QoL

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Hurvitz, Sara A., Fabrice Andre, Massimo Cristofanilli, et al. "A phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a nonsteroidal aromatase inhibitor (VIKTORIA-1)." Journal of Clinical Oncology 41, no. 16_suppl (2023): TPS1118. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.tps1118.

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TPS1118 Background: Patients who receive frontline CDK4/6 inhibitor (CDK4/6i) therapy eventually experience disease progression. Resistance to CDK4/6i is likely a transient adaptive mechanism that may be reversed by inhibition of the PI3K/mTOR pathway. Thus, combination of CDK4/6i and PI3K/mTORi after disease progression on CDK4/6i could restore sensitivity to CDK4/6i and prevent activation of the PI3K/mTOR pathway. This hypothesis was evaluated in a Phase 1b study (Layman SABCS 2021) of gedatolisib (geda), a potent inhibitor of PI3K and mTOR. Subjects with HR+/HER2- ABC with prior CDK4/6i rec

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Molyneaux, Michael, John Xu, David M. Evans та Patrick Lu. "Effect on tumor growth by TGF-β1/COX-2 siRNA combination product (STP705) in a human cholangiocarcinoma (HuCCT-1) xenograft tumor model in nude mice." Journal of Clinical Oncology 37, № 15_suppl (2019): e14652-e14652. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e14652.

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e14652 Background: Cholangiocarcinoma (CCA) is a hepatobiliary cancer and although there have been advances recently there is a need for additional treatment methods for patients. Over expressions of TGF-β1 and COX-2 have been reported to play key roles in tumorigenesis of CCA. We studied the effect of STP705 on the growth of HuCCT-1 xenograft tumors in nude mice. STP705 is a TGF-β1/COX-2 specific siRNA combination product formulated in Histidine-Lysine co-Polymer nanoparticle delivery system. Methods: HuCCT-1 xenograft tumors were implanted subcutaneously into 24 BALB/c nude female mice (n =

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Shu, Catherine A., Koichi Goto, Byoung Chul Cho, et al. "CHRYSALIS-2: A phase 1/1b study of lazertinib as monotherapy and in combination with amivantamab in patients with EGFR-mutant NSCLC." Journal of Clinical Oncology 39, no. 15_suppl (2021): TPS9132. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.tps9132.

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TPS9132 Background: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have improved clinical outcomes for patients with EGFR mutant (EGFRm) non-small cell lung cancer (NSCLC); however, patients will inevitably progress due to acquired resistance mutations. Lazertinib is a potent, brain-penetrant, 3rd-generation EGFR TKI with efficacy against activating EGFR and resistance T790M mutations. Amivantamab is an EGFR-MET bispecific antibody with immune cell-directing activity that targets activating EGFR and MET mutations. Synergistic inhibition of the EGFR by targeting the r

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Johnson, Benny, Cara Haymaker, Van K. Morris, et al. "Abstract CT118: A phase I/II trial of a CXCR1/2 inhibitor in combination with anti-PD-1 for circulating tumor DNA (ctDNA) positive & refractoryRAS-mutated microsatellite stable (MSS) colorectal cancer." Cancer Research 83, no. 8_Supplement (2023): CT118. http://dx.doi.org/10.1158/1538-7445.am2023-ct118.

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Abstract Background: Preclinical CRC models reveal KRAS mutations activate the CXCR2 axis promoting an immunosuppressive tumor microenvironment (TME). This occurs via KRAS repression of interferon regulatory factor 2 (IRF2) resulting in upregulation of CXCL3 chemokines, which bind CXCR2 and recruit myeloid-derived suppressor cells (MDSC; Liao et al, Cancer Cell 2019). MDSCs also accelerate metastases by ‘priming’ the premetastatic niche via promoting egress of tumors cells into the circulation, inhibiting killing by immune cells and promoting extravasation into the tissues (Veglia et al. Natur

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Li, Lin, Ping Zhang, Jiayi Gao, et al. "Preliminary efficacy and safety of camrelizumab plus metronomic oral vinorelbine as first-line therapy for people aged 70 and above with advanced non-small cell lung cancer (NSCLC) from a phase II trial." Journal of Clinical Oncology 41, no. 16_suppl (2023): e14677-e14677. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.e14677.

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e14677 Background: Traditional platinum-based combination chemotherapy used as the standard first‐line treatment for advanced NSCLC poses potential safety risk for patients (pts) aged 70 years and above. Moreover, data on immune checkpoint inhibitors treating older pts with lung cancer in the current pivotal trials is limited. Metronomic chemotherapy (MCT) is the frequent administration of chemotherapy drugs at lower doses each time. Compared with traditional chemotherapy, MCT shows better safety profile and antitumor angiogenesis and immunomodulatory effects. Camrelizumab, an anti-PD-1 inhibi

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Hauschild, A., U. Trefzer, C. Garbe, et al. "A phase II multicenter study on the histone deacetylase (HDAC) inhibitor MS-275, comparing two dosage schedules in metastatic melanoma." Journal of Clinical Oncology 24, no. 18_suppl (2006): 8044. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.8044.

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8044 Background: The acetylation of histones is a key component of gene regulation, which plays an important role in tumor initiation and progression. MS-275, an inhibitor of the benzamide series, is a synthetic orally available inhibitor of HDACs which showed anti-tumor activity in 3 phase 1 trials. Methods: A phase II, multicenter, randomized, parallel-group study of oral MS-275 evaluated the efficacy and toxicity in patients with non-resectable metastatic melanoma. Patients should have received at least one, but not more than two previous systemic therapies (chemo- and/or immunotherapy) for

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Rosen, Ezra, Manish Sharma, David Berz, et al. "Phase 1/2 dose expansion study evaluating first-in-class eIF4A inhibitor zotatifin in patients with ER+ metastatic breast cancer." Journal of Clinical Oncology 41, no. 16_suppl (2023): 1080. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.1080.

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1080 Background: Zotatifin (eFT226) is a first-in-class, potent and sequence selective inhibitor of RNA helicase eIF4A that promotes a stable mRNA:eIF4A:drug ternary complex at specific polypurine motifs within the 5’-UTR, preventing translation of select transcripts. In preclinical models zotatifin treatment simultaneously down-regulated translation of numerous oncogenes including CDK4, ERα, ERBB2, KRAS, and CCND1. Methods: Following a 3+3 dose escalation portion of the protocol (Part 1), Part 2 is a Simon’s two-stage design of cohorts of up to 18 patients (pts) with ER+ metastatic breast can

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Miljkovic, Milos D., Kevin C. Conlon, Jennifer Hsu, Clare Sun, Adrian Wiestner, and Thomas A. Waldmann. "Phase 1 Trial of Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocytic Leukemia." Blood 134, Supplement_1 (2019): 3052. http://dx.doi.org/10.1182/blood-2019-130807.

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Background: Of the several drugs and drug combinations approved for treatment of relapsed and refractory chronic lymphocytic leukemia (CLL), the reported complete response rates are no greater than 30%. Obinutuzumab is a glycoengineered, humanized type 2 anti-CD20 monoclonal antibody thought to engage the immune system by directly activating antibody- dependent, cell-mediated cytotoxicity (ADCC); it is approved for treatment of chronic lymphocytic leukemia in combination with chlorambucil. The key mediators of ADCC are polymorphonuclear neutrophils, monocytes, and natural killer (NK) cells. Re

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Appleman, James Richard, and Stephen Evan Webber. "Discovery of a novel Toll-like Receptor 7 agonist for systemic immunotherapy of cancer." Journal of Clinical Oncology 37, no. 15_suppl (2019): e14246-e14246. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e14246.

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e14246 Background: While ICPIs (immune checkpoint inhibitors) have fundamentally changed the practice of cancer therapy for tumors arising from many different tissues, ways to increase both response rate and durability are critically needed. On theoretical grounds, combining stimulators of innate immunity with activators of adaptive immunity should lead to better outcomes. We have therefore created a series of novel Toll-like receptor 7 (TLR7) agonists that are intended to be combined with activators of adaptive immunity for the treatment of cancer. We have previously reported a series of unus

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Gu, Zexian, Xiaoqing Zhao, Pei Huang, Junwei Pu, Xinyu Shi, and Yungang Li. "Identification of Multi-Dimensional Relative Poverty and Governance Path at the Village Scale in an Alpine-Gorge Region: A Case Study in Nujiang, China." International Journal of Environmental Research and Public Health 20, no. 2 (2023): 1286. http://dx.doi.org/10.3390/ijerph20021286.

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Absolute poverty has historically been solved in China, and the focus on poor areas has shifted to addressing relative poverty. To realize the organic combination of the rural revitalization strategy and relative poverty governance, multi-dimensional relative poverty identification and governance path research at the village scale in an alpine-gorge region is required. For this study, the Nujiang Lisu Autonomous Prefecture’s research area in a typical alpine-gorge was chosen. This paper constructed an evaluation index system for the rural regional system based on location conditions, ecologica

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Shen, Sherry, Stephanie Downs-Canner, Fresia Pareja, et al. "Abstract P4-08-05: A Phase Ib/II trial of Lenvatinib plus Pembrolizumab plus Fulvestrant in ER+/HER2- Metastatic Breast Cancer (MBC)." Clinical Cancer Research 31, no. 12_Supplement (2025): P4–08–05—P4–08–05. https://doi.org/10.1158/1557-3265.sabcs24-p4-08-05.

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Abstract Background: The prognosis for endocrine-resistant ER+/HER2- MBC remains poor and novel therapeutic strategies are urgently needed. Immunotherapy is FDA-approved in triple negative breast cancer but has not shown significant efficacy in ER+ BC. This is likely due to differences in immunogenicity, as ER+ tumors are characterized by low levels of tumor-infiltrating lymphocytes, lower mutational load, and lower PDL1 expression; furthermore, driver alterations associated with ER+ BC can contribute to suppressing immunity. Single-agent immunotherapy has yielded low overall response rates (O

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