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Monoclonal Antibody-Mediated Chemotherapy

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161. Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design. (PubMed)

Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design. Avelumab is a human anti-PD-L1 IgG1 monoclonal antibody that has shown antitumor activity in early phase studies in advanced/metastatic gastric/gastroesophageal junction cancer, including as first-line maintenance therapy. Here, we describe the design of JAVELIN Gastric 100 (NCT02625610), an open-label, Phase III trial. A total of 499 patients with locally advanced/metastatic (...) HER2- gastric/gastroesophageal junction cancer adenocarcinoma, who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy, have been randomized 1:1 to receive avelumab maintenance therapy or continue chemotherapy. The primary objective is to demonstrate superior overall survival in all randomized patients or in the PD-L1+ population. Secondary objectives are to demonstrate superiority for progression-free survival and objective response rate

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2019 Future oncology (London, England)

162. Protective effect of bevacizumab on chemotherapy-related acute exacerbation of interstitial lung disease in patients with advanced non-squamous non-small cell lung cancer. (PubMed)

Protective effect of bevacizumab on chemotherapy-related acute exacerbation of interstitial lung disease in patients with advanced non-squamous non-small cell lung cancer. Acute exacerbation of interstitial lung disease (AE-ILD) is the most serious complication in lung cancer patients with pre-existing ILD receiving chemotherapy. The role of vascular endothelial growth factor (VEGF) in pathogenesis of AE-ILD is conflicting. The influence of bevacizumab (Bev), a monoclonal antibody against VEGF (...) , on lung cancer patients with pre-existing ILD remains unclear. We examined the effect of Bev on reducing AE-ILD risk in non-squamous non-small cell lung cancer (NSCLC) patients receiving chemotherapy.We analysed incidence of AE-ILD and outcomes of 48 patients with advanced non-squamous NSCLC with ILD who received first-line chemotherapy with (Bev group, n = 17) and without (non-Bev group, n = 31) Bev between July 2011 and July 2016. Gray's test, which was competing risk analysis during the study

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2019 BMC pulmonary medicine

163. Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)

or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study drug. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization. Has an active autoimmune disease that has required systemic treatment in the past 2 years. Has had a prior anti-cancer monoclonal antibody (mAb) for direct anti-neoplastic (...) Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361) Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail

2016 Clinical Trials

164. Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434)

participating or has participated in a study with an investigational compound or device within 4 weeks, or 5 times half-life of the investigational compound, whichever is longer, of initial dosing on this study For Part A: Has had chemotherapy, targeted small molecule therapy, radiotherapy, major surgery, or biological cancer therapy (including monoclonal antibodies) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication, or who has not recovered (≤ Grade 1 (...) dose of study medication Has a known hypersensitivity to the components of the trial treatment or another monoclonal antibody For Part B: Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel or pemetrexed. For Part B: Is on chronic systemic steroids with the exception of use of bronchodilators, inhaled steroids, or local steroid injections For Part B cohort 1 and 2: Is unable to interrupt aspirin or other nonsteroidal ant-inflammatory drugs (NSAIDs), other than an aspirin

2016 Clinical Trials

165. Bioprocess development of antibody-drug conjugate production for cancer treatment. (PubMed)

Bioprocess development of antibody-drug conjugate production for cancer treatment. Antibody-drug conjugate (ADC) is a class of targeted cancer therapies that combine the advantages of monoclonal antibody (mAb)'s specific targeting and chemotherapy's potent cytotoxicity. The therapeutic effect of ADC is significantly affected by its bioproduction process. This study aims to develop an effective ADC production process using anti-HER2 mAb-drug as a model therapeutic. First, a high titer (>2 g/L

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2018 PLoS ONE

166. Antibody-Drug Conjugate-Based Therapeutics: State of the Science. (PubMed)

Antibody-Drug Conjugate-Based Therapeutics: State of the Science. Antibody-drug conjugates (ADCs) are complex engineered therapeutics consisting of monoclonal antibodies, directed toward tumor-associated antigens, to which highly potent cytotoxic agents are attached using chemical linkers. This targeted drug delivery strategy couples the precision of the antibody targeting moiety with the cytocidal activity of the payload, which is generally too toxic on its own to be systemically administered (...) . In this manner, ADCs confer a means to reduce off-target toxicities in patients by limiting the exposure of normal tissues to the payload, thus broadening the potential therapeutic window compared with traditional chemotherapy. The pace of ADC development is accelerating, with the number of investigational agents in human trials having more than tripled over the past 5 years, underscoring the enthusiasm for this transformative approach to cancer treatment. Here, we review the key structural elements of ADC

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2019 Journal of the National Cancer Institute

167. Antibody-drug conjugates in clinical trials for lymphoid malignancies and multiple myeloma. (PubMed)

Antibody-drug conjugates in clinical trials for lymphoid malignancies and multiple myeloma. Antibody-drug conjugates (ADC) represent a distinct family of chemoimmunotherapy agents. ADCs are composed of monoclonal antibodies conjugated to cytotoxic payloads via specialized chemical linkers. ADCs therefore combine the immune therapy with targeted chemotherapy. Due to the distinct biomarkers associated with lymphocytes and plasma cells, ADCs have emerged as a promising treatment option

2019 Journal of hematology & oncology

168. Gemtuzumab ozogamicin (Mylotarg) with conventional chemotherapy for acute myeloid leukaemia - first line

publication URL Indexing Status Subject indexing assigned by CRD MeSH Aminoglycosides; Antibodies, Monoclonal, Humanized; Humans; Leukemia, Myeloid, Acute Language Published English Country of organisation England English summary An English language summary is available. Address for correspondence NIHR Horizon Scanning Research&Intelligence Centre, University of Birmingham, Institute of Applied Health Research, Public Health building, Edgbaston, Birmingham B15 2TT Tel: 0121 414 9077 Email: nihrhsc (...) Gemtuzumab ozogamicin (Mylotarg) with conventional chemotherapy for acute myeloid leukaemia - first line Gemtuzumab ozogamicin (Mylotarg) with conventional chemotherapy for acute myeloid leukaemia – first line Gemtuzumab ozogamicin (Mylotarg) with conventional chemotherapy for acute myeloid leukaemia – first line NIHR HSRIC Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database

2015 Health Technology Assessment (HTA) Database.

169. Obinutuzumab (Gazyvaro) for indolent non-Hodgkin lymphoma - first line, in combination with chemotherapy

. Citation NIHR HSRIC. Obinutuzumab (Gazyvaro) for indolent non-Hodgkin lymphoma – first line, in combination with chemotherapy. Birmingham: NIHR Horizon Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 Authors' objectives Obinutuzumab is a humanised and glyco-engineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies such as indolent non-Hodgkin lymphoma (NHL). Such antibodies act by increasing antibody-dependent cellular cytotoxicity, which increases (...) ) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone). Currently, obinutuzumab is in one phase III study comparing its effects on progression free survival against treatment with rituximab (both with chemotherapy). This trial is expected to complete in March 2017. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Humans; Lymphoma, Non-Hodgkin Language Published English Country

2015 Health Technology Assessment (HTA) Database.

170. Ipilimumab (Yervoy) for chemotherapy-naïve hormone-relapsed metastatic prostate cancer

(Yervoy) for chemotherapy-naïve hormone-relapsed metastatic prostate cancer. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2015 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Adult; Androgen Antagonists; Angiogenesis Inhibitors; Antibodies, Monoclonals; Antineoplastic Agents; Disease Progression; Male; Neoplasm Metastasis; Neoplasm Recurrence, Local; Neoplasm Staging; Prostatic Neoplasms; Taxoids Language Published English Country (...) Ipilimumab (Yervoy) for chemotherapy-naïve hormone-relapsed metastatic prostate cancer Ipilimumab (Yervoy) for chemotherapy-naïve hormone-relapsed metastatic prostate cancer Ipilimumab (Yervoy) for chemotherapy-naïve hormone-relapsed metastatic prostate cancer NIHR HSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation NIHR HSC. Ipilimumab

2015 Health Technology Assessment (HTA) Database.

171. A Dose Escalation and Cohort Expansion Study of CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 Antibody (Nivolumab) or in Combination With Nivolumab and Anti-CTLA4 Antibody (Ipilimumab) in Patients With Select Advanced or Metastatic Solid

, a protein which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to expand these cells to promote their anti-tumor effects. Nivolumab is a full human monoclonal antibody that binds to a molecule called PD-1 (programmed cell death protein 1) on immune cells and promotes anti-tumor effects. Part 1: Dose escalation of NKTR-214 in combination with nivolumab. A total of 38 eligible patients were enrolled into one of five dose regimens of NKTR-214 in combination with nivolumab (...) ) Class III heart failure No prior chemotherapy for inoperable locally advanced or metastatic urothelial carcinoma. Prior local intravesical chemotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment. Patients must not have received any prior immune-oncology regimens, including but not limited to checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co

2016 Clinical Trials

172. Bevacizumab (Avastin) for recurrent or persistent stage IVB cervical cancer ? in combination with chemotherapy

of this assessment has been made for the HTA database. Citation NIHR HSC. Bevacizumab (Avastin) for recurrent or persistent stage IVB cervical cancer – in combination with chemotherapy. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2014 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanizeds; Uterine Cervical Neoplasms Language Published English Country of organisation England English summary (...) Bevacizumab (Avastin) for recurrent or persistent stage IVB cervical cancer ? in combination with chemotherapy Bevacizumab (Avastin) for recurrent or persistent stage IVB cervical cancer – in combination with chemotherapy Bevacizumab (Avastin) for recurrent or persistent stage IVB cervical cancer – in combination with chemotherapy NIHR HSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality

2014 Health Technology Assessment (HTA) Database.

173. Obinutuzumab in combination with CHOP chemotherapy for CD20-positive diffuse large B-cell lymphoma ? first line

of this assessment has been made for the HTA database. Citation NIHR HSC. Obinutuzumab in combination with CHOP chemotherapy for CD20-positive diffuse large B-cell lymphoma – first line. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2014 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocolss; Lymphoma, B-Cell Language Published English Country of organisation England English (...) Obinutuzumab in combination with CHOP chemotherapy for CD20-positive diffuse large B-cell lymphoma ? first line Obinutuzumab in combination with CHOP chemotherapy for CD20-positive diffuse large B-cell lymphoma – first line Obinutuzumab in combination with CHOP chemotherapy for CD20-positive diffuse large B-cell lymphoma – first line NIHR HSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality

2014 Health Technology Assessment (HTA) Database.

174. Signal Detection in Monoclonal and New Agents in Lymphoma

(external analysis). An economical study is embedded. As the LYSA data contained all fully monitored patients' bio clinical and demographic characteristics, special attention will be paid to the addition of new agents, in particular anti-CD20 antibody, to the cytotoxic chemotherapy regimens in conjunction with other well-known risk factors (e.g. tobacco, obesity, comorbidities; internal analysis). Data will be reported according to the initial NHL treatment strategy and cross-validated by long-term (...) characteristics, initial location of the cancer, its treatment and possible iatrogenic complications. Study Design Go to Layout table for study information Study Type : Observational [Patient Registry] Actual Enrollment : 1671 participants Observational Model: Cohort Time Perspective: Prospective Target Follow-Up Duration: 1 Day Official Title: Detection of Long Term Toxicity of Monoclonal Agents Combined With Chemotherapy in Non-Hodgkin Lymphoma - the SIMONAL Project Study Start Date : April 2015 Actual

2016 Clinical Trials

175. Ramucirumab for treating advanced gastric cancer or gastro-oesophageal junction adenocarcinoma previously treated with chemotherapy

-targeted monoclonal antibody that specifically binds vascular endothelial growth factor (VEGF) receptor-2. This interaction prevents VEGF receptor-2 from binding with activating ligands (VEGF-A, VEGF-C and VEGF-D). Upregulation of VEGF-A, VEGF-C and VEGF-D ligands in gastric cancer is associated with poorer prognosis for people with resected or metastatic disease. 2.3 The summary of product characteristics lists the following adverse reactions: fatigue or asthenia (weakness), neutropenia, leukopenia (...) Ramucirumab for treating advanced gastric cancer or gastro-oesophageal junction adenocarcinoma previously treated with chemotherapy Ramucirumab for treating advanced Ramucirumab for treating advanced gastric cancer or gastro–oesophageal gastric cancer or gastro–oesophageal junction adenocarcinoma pre junction adenocarcinoma previously viously treated with chemother treated with chemotherap apy y T echnology appraisal guidance Published: 27 January 2016 nice.org.uk/guidance/ta378 © NICE 2018

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

176. Randomized phase II study of the anti-epidermal growth factor receptor monoclonal antibody cetuximab with cisplatin versus cisplatin alone in patients with metastatic triple-negative breast cancer. (PubMed)

Randomized phase II study of the anti-epidermal growth factor receptor monoclonal antibody cetuximab with cisplatin versus cisplatin alone in patients with metastatic triple-negative breast cancer. Epidermal growth factor receptor is overexpressed in metastatic triple-negative breast cancers (mTNBCs), an aggressive subtype of breast cancer. Our randomized phase II study investigated cisplatin with or without cetuximab in this setting.Patients who had received no more than one previous (...) chemotherapy regimen were randomly assigned on a 2:1 schedule to receive no more than six cycles of cisplatin plus cetuximab or cisplatin alone. Patients receiving cisplatin alone could switch to cisplatin plus cetuximab or cetuximab alone on disease progression. The primary end point was overall response rate (ORR). Secondary end points studied included progression-free survival (PFS), overall survival (OS), and safety profiles. Analyses included a significance level of α = .10 with no adjustments

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2013 Journal of Clinical Oncology

177. Randomized Phase II Study of the Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Cetuximab With Cisplatin Versus Cisplatin Alone in Patients With Metastatic Triple-Negative Breast Cancer. (PubMed)

Randomized Phase II Study of the Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Cetuximab With Cisplatin Versus Cisplatin Alone in Patients With Metastatic Triple-Negative Breast Cancer. Epidermal growth factor receptor is overexpressed in metastatic triple-negative breast cancers (mTNBCs), an aggressive subtype of breast cancer. Our randomized phase II study investigated cisplatin with or without cetuximab in this setting.Patients who had received no more than one previous (...) chemotherapy regimen were randomly assigned on a 2:1 schedule to receive no more than six cycles of cisplatin plus cetuximab or cisplatin alone. Patients receiving cisplatin alone could switch to cisplatin plus cetuximab or cetuximab alone on disease progression. The primary end point was overall response rate (ORR). Secondary end points studied included progression-free survival (PFS), overall survival (OS), and safety profiles. Analyses included a significance level of α = .10 with no adjustments

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2013 Journal of clinical oncology : official journal of the American Society of Clinical Oncology

178. Phase II study of lutetium-177 labeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 for metastatic castration-resistant prostate cancer. (PubMed)

Phase II study of lutetium-177 labeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 for metastatic castration-resistant prostate cancer. To assess the efficacy of a single infusion of radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 (lutetium-177; (177)Lu) by prostate-specific antigen (PSA) decline, measurable disease response, and survival.In this dual-center phase II study, two cohorts with progressive metastatic castration (...) -resistant prostate cancer received one dose of (177)Lu-J591 (15 patients at 65 mCi/m(2), 17 at 70 mCi/m(2)) with radionuclide imaging. Expansion cohort (n = 15) received 70 mCi/m(2) to verify response rate and examine biomarkers.Forty-seven patients who progressed after hormonal therapies (55.3% also received prior chemotherapy) received (177)Lu-J591. A total of 10.6% experienced ≥50% decline in PSA, 36.2% experienced ≥30% decline, and 59.6% experienced any PSA decline following their single treatment

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2013 Clinical Cancer Research

179. Clinical development of immunostimulatory monoclonal antibodies and opportunities for combination. (PubMed)

Clinical development of immunostimulatory monoclonal antibodies and opportunities for combination. Immune system responses are under the control of extracellular biomolecules, which express functions in receptors present on the surface of cells of the immune system, and thus are amenable to be functionally modulated by monoclonal antibodies. Some of these mechanisms are activating and dictate whether the response ensues, while others play the role of powerful repressors. Antagonist antibodies (...) -PD-L1 (B7-H1), anti-KIR, and anti-TGF-β. Agonist antibodies currently being investigated in clinical trials target CD40, CD137 (4-1BB), CD134 (OX40), and glucocorticoid-induced TNF receptor (GITR). A blossoming preclinical pipeline suggests that other active targets will also be tested in patients in the near future. All of these antibodies are being developed as conventional monoclonal immunoglobulins, but other engineered antibody formats or RNA aptamers are under preclinical scrutiny

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2013 Clinical Cancer Research

180. Combination of two anti-CD5 monoclonal antibodies synergistically induces complement-dependent cytotoxicity of chronic lymphocytic leukaemia cells. (PubMed)

Combination of two anti-CD5 monoclonal antibodies synergistically induces complement-dependent cytotoxicity of chronic lymphocytic leukaemia cells. The treatment of chronic lymphocytic leukaemia (CLL) has been improved by introduction of monoclonal antibodies (mAbs) that exert their effect through secondary effector mechanisms. CLL cells are characterized by expression of CD5 and CD23 along with CD19 and CD20, hence anti-CD5 Abs that engage secondary effector functions represent an attractive (...) opportunity for CLL treatment. Here, a repertoire of mAbs against human CD5 was generated and tested for ability to induce complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) both as single mAbs and combinations of two mAbs against non-overlapping epitopes on human CD5. The results demonstrated that combinations of two mAbs significantly increased the level of CDC compared to the single mAbs, while no enhancement of ADCC was seen with anti-CD5 mAb combinations

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2013 British journal of haematology

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