Latest & greatest articles for nivolumab

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Top results for nivolumab

1. Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial. (Abstract)

Adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): a randomised, double-blind, placebo-controlled, phase 2 trial. Nivolumab and ipilimumab, alone or in combination, are widely used immunotherapeutic treatment options for patients with advanced-ie, unresectable or metastatic-melanoma. This criterion, however, excludes patients with stage IV melanoma with no evidence of disease. We therefore (...) aimed to evaluate the safety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in this patient population.We did a randomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres. Eligible patients were aged 18-80 years with stage IV melanoma with no evidence of disease after surgery or radiotherapy. Key exclusion criteria included uveal or mucosal melanoma, previous therapy with checkpoint inhibitors, and any previous

2020 Lancet

2. Nivolumab provides improved effectiveness and safety compared with docetaxel as a second-line treatment for advanced non-small cell lung cancer: A systematic review and meta-analysis. (Full text)

Nivolumab provides improved effectiveness and safety compared with docetaxel as a second-line treatment for advanced non-small cell lung cancer: A systematic review and meta-analysis. As an inhibitor of programmed death-1 (PD-1) protein, nivolumab has been shown to be effective in various cancers. We thus conducted this meta-analysis to compare the relative efficacy of nivolumab vs docetaxel-based chemotherapy as a second-line treatment for previously treated advanced non-small cell lung cancer (...) (NSCLC).Relevant studies were identified through searches of databases and conference proceedings. Progression-free survival (PFS), overall survival (OS), drug responses, and adverse effects (AEs) were assessed as the primary endpoints.After screening, we included six studies (949 patients) in the final analysis. Nivolumab showed better efficacy in terms of the PFS (hazard ratios [HR]: 0.70, P = 0.03), OS (HR: 0.70, P < 0.00001), objective response rate (ORR) (risk ratios [RR]: 1.73, P = 0.0008

2020 Cancer medicine PubMed abstract

3. The different benefits and side effects of nivolumab combined with ipilimumab in diverse cancer: A Protocol for Systematic Review. (Full text)

The different benefits and side effects of nivolumab combined with ipilimumab in diverse cancer: A Protocol for Systematic Review. This systematic review protocol aims to provide the methods used to assess the total benefits and side effects in all cancer patients and their respective benefits and side effects in different cancers.The following electronic bibliographic databases will be selected without any language restriction: PubMed, EMBASE, The Cochrane Library, Scopus and Web of Science (...) without an upper-limit date until July 12, 2019. Searches will also be performed in the following trials registers: ClinicalTrials.gov (www.ClinicalTrials.gov), the ISRCTN registry (www.isrctn.com), the WHO International Clinical Trials Registry Platform (www.who.int/trialsearch/Default.aspx) and the EU Clinical Trials Register (www.clinicaltrialsregister.eu). All randomized controlled trials related to the combination of nivolumab and ipilimumab for cancer patients will be included. Outcomes

2020 Medicine PubMed abstract

4. Nivolumab for the Treatment of Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (nccRCC): A Single-Institutional Experience and Literature Meta-Analysis. (Full text)

Nivolumab for the Treatment of Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma (nccRCC): A Single-Institutional Experience and Literature Meta-Analysis. Nivolumab alone and in combination with ipilimumab is approved for the treatment of patients with metastatic renal cell carcinoma (RCC) who received prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI) and those who are treatment naive, respectively. However, the clinical activity of nivolumab (...) in non-clear cell RCC (nccRCC) is unknown, as these patients were excluded from the trials.We reviewed the records of patients who received nivolumab for nccRCC and ccRCC with >20% rhabdoid with the primary endpoint to assess the objective response rate (ORR). We assessed radiographic response using RECIST, v1.1. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). We also reviewed the literature to identify studies reporting on the clinical activity of immune

2020 The oncologist PubMed abstract

5. Potential Immune-Related Adverse Events Associated With Monotherapy and Combination Therapy of Ipilimumab, Nivolumab, and Pembrolizumab for Advanced Melanoma: A Systematic Review and Meta-Analysis. (Full text)

Potential Immune-Related Adverse Events Associated With Monotherapy and Combination Therapy of Ipilimumab, Nivolumab, and Pembrolizumab for Advanced Melanoma: A Systematic Review and Meta-Analysis. Background: The use of ipilimumab, nivolumab, and pembrolizumab as monotherapies or in combination has transformed the management of advanced melanoma even though these drugs are associated with a new profile of immune-related adverse events (irAEs). The incidence of irAEs from clinical trials (...) of these agents is an important factor for clinicians when treating patients with advanced melanoma. In the current study, we aimed to profile the incidence of potential irAEs of these agents when used as monotherapy and as combination therapy. Methods: We searched the Medline, Embase, and Cochrane databases; clinicaltrials.gov; and websites of regulatory agencies in the USA, Europe, Australia, and Japan for phase 1-3 trials of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma. Random effect meta

2020 Frontiers in oncology PubMed abstract

6. Comparative Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Advanced Cancer: A Systematic Review and Meta-Analysis. (Full text)

Comparative Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Advanced Cancer: A Systematic Review and Meta-Analysis. Combination therapy with immune checkpoint inhibitors (ICIs) has been applied in the clinic to achieve synergistic effects and to improve clinical efficacy. Compared with monotherapy, combination therapy has promising efficacy against various advanced cancers. To further verify the effectiveness of combination therapy, we conducted a meta-analysis of the efficacy (...) and safety of nivolumab (NIVO) and NIVO plus ipilimumab (IPI) in advanced cancer.Electronic databases (PubMed, EMbase, and The Cochrane Library) were systematically searched for applicable studies published in English between January 1990 and June 2019. Relevant outcomes included objective response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), median overall survival (mOS), and grade 3-4 adverse events (AEs).A total of 1,297 patients from six studies were included

2020 Frontiers in pharmacology PubMed abstract

7. Efficacy of nivolumab as checkpoint inhibitor drug on survival rate of patients with relapsed/refractory classical Hodgkin lymphoma: a meta-analysis of prospective clinical study. (Abstract)

Efficacy of nivolumab as checkpoint inhibitor drug on survival rate of patients with relapsed/refractory classical Hodgkin lymphoma: a meta-analysis of prospective clinical study. The primary standard treatment for classic Hodgkin's lymphoma (cHL) is chemotherapy and radiation therapy. However, some patients get relapsed, or their diseases become resistant. PD1 blocking antibodies have been used to increase the response of treatment in solid tumors, and led to potentially stable responses (...) that are acceptable. Our purpose in this study is to investigate the effect of nivolumab as a PD1 blocking antibody on the survival rate of patients with Hodgkin's cancer.Databases were found in International Medical Sciences, Web of Science, Medline, Scopus, Index Copernicus, PubMed, DOAJ, Google Scholar, EBSCO-CINAHL, and Persian databases containing SID and Magiran using keywords such as: "checkpoint inhibitor", "nivolumab", "Hodgkin lymphoma", and "PD1 Blockade". The risk of bias was determined by two

2020 Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico

8. Nivolumab (renal cell carcinoma) - Addendum to Commissions A19-11 and A19-12

Nivolumab (renal cell carcinoma) - Addendum to Commissions A19-11 and A19-12 1 Translation of addendum A19-54 Nivolumab (Nierenzellkarzinom) – Addendum zu den Aufträgen A19-11 und A19-12 (Version 1.0; Status: 19 July 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 19 July 2019 1.0 Commission: A19-54 Version: Status: IQWiG Reports – Commission (...) No. A19-54 Nivolumab (renal cell carcinoma) – Addendum to Commissions A19-11 and A19-12 1 Addendum A19-54 Version 1.0 Nivolumab – Addendum to Commissions A19-11 and A19-12 19 July 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (renal cell carcinoma) – Addendum to Commissions A19-11 and A19-12 Commissioning agency: Federal Joint Committee Commission awarded on: 24 June 2019

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

9. Antitumor Activity and Treatment-Related Toxicity Associated With Nivolumab Plus Ipilimumab in Advanced Malignancies: A Systematic Review and Meta-Analysis. (Full text)

Antitumor Activity and Treatment-Related Toxicity Associated With Nivolumab Plus Ipilimumab in Advanced Malignancies: A Systematic Review and Meta-Analysis. Combining immune checkpoint inhibitors has shown its efficacy compared to monotherapy in advanced malignancies. We conducted this meta-analysis to provide latest evidence on the objective response rate (ORR) and incidence of treatment-related high-grade adverse events (AEs) during nivolumab and ipilimumab combination treatment and further (...) . There was no significant difference between nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks (N3I1-Q3W) and nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks (N1I3-Q3W) arms in ORR [30.8% vs 41%; odds ratio (OR), 0.72; 95% CI, 0.39-1.30; P = 0.275]. Grade 3-4 AEs related to combination therapy occurred in 39.9% (95% CI, 33.5-46.7%) of patients; the most commonly reported grade 3-4 treatment-related AEs were diarrhea (5.28%), colitis (3.96%) and increased alanine aminotransferase (3.51%). Incidence

2019 Frontiers in pharmacology PubMed abstract

10. Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation - GOV.UK GOV.UK uses cookies which are essential for the site to work. We also use non-essential cookies to help us improve government digital services. Any data collected is anonymised. By continuing to use this site, you agree to our use of cookies. Accept cookies You’ve accepted all cookies. You can (...) at any time. Hide Search Register by 26 November to vote in the General Election on 12 December. Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV). Published 18 October 2019 From: Therapeutic area

2019 MHRA Drug Safety Update

11. Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (renal cell carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (Nierenzellkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-11 Nivolumab (...) (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-11 Version 1.0 Nivolumab (renal cell carcinoma) 13 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (renal cell carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 4 February

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. (Full text)

Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial.We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg (...) per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group.At a minimum follow-up of 60 months

2019 NEJM PubMed abstract

13. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. (Abstract)

Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC.In this open-label, phase 3 trial, we randomly assigned (...) patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus

2019 NEJM

14. Pneumonitis in Irradiated Lungs After Nivolumab: A Brief Communication and Review of the Literature. (Abstract)

Pneumonitis in Irradiated Lungs After Nivolumab: A Brief Communication and Review of the Literature. Nivolumab is a feasible therapy option in patients with advanced non-small cell lung cancer (NSCLC) who progress on first-line treatment. However, there is limited information about an overlapping toxicity of PD-1 inhibitors when administered following thoracic radiotherapy (TRT). Three of 25 patients with advanced NSCLC were treated with palliative or curative intent. Nivolumab was initiated (...) as second or third-line therapy after TRT for recurrent or progressive disease. All 3 patients developed grade 3 pneumonitis at some point during nivolumab therapy. Herein, we describe 3 cases of pneumonitis in patients with NSCLC started on nivolumab following TRT. Imaging analysis was strongly consistent with heterogenous lung parenchyma changes in the irradiated lung volume receiving a total dose of 15-20 Gy. Pulmonary toxicity was manageable; however, interruption of immunotherapy was necessary.

2019 Journal of immunotherapy (Hagerstown, Md. : 1997)

15. Ipilimumab/nivolumab (Yervoy/Opdivo) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma

Ipilimumab/nivolumab (Yervoy/Opdivo) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma Ipilimumab/nivolumab (Yervoy®/Opdivo®) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma | Report | National Health Care Institute You are here: Ipilimumab/nivolumab (Yervoy®/Opdivo®) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma Search within (...) English part of National Health Care Institute Search Ipilimumab/nivolumab (Yervoy®/Opdivo®) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma Zorginstituut Nederland has completed its assessment whether ipilimumab/nivolumab (Yervoy®/Opdivo®) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma, can be included in the insured package. Due to its expected high costs the Minister of Health, Welfare

2019 National Health Care Institute (Zorginstituut Nederland)

16. Nivolumab (Opdivo) - for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC)

Nivolumab (Opdivo) - for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC) 1 Published 10 June 2019 1 SMC2153 nivolumab 10mg/ml concentrate for solution for dilution (Opdivo®) Bristol-Myers Squibb Pharmaceuticals Ltd 10 May 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised (...) as follows: ADVICE: following a full submission assessed under the end of life process nivolumab (Opdivo ® ) is accepted for use within NHSScotland. Indication under review: in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). Overall survival was significantly longer in the nivolumab plus ipilimumab group compared with a multiple receptor tyrosine kinase inhibitor in a phase III study in treatment naïve patients

2019 Scottish Medicines Consortium

17. Intracranial antitumor responses of nivolumab and ipilimumab: a pharmacodynamic and pharmacokinetic perspective, a scoping systematic review. (Full text)

Intracranial antitumor responses of nivolumab and ipilimumab: a pharmacodynamic and pharmacokinetic perspective, a scoping systematic review. Recently, two phase II trials showed intracranial activity of the immune checkpoint inhibitors nivolumab and ipilimumab in patients with melanoma brain metastases. However, it is generally assumed that large molecules like monoclonal antibodies nivolumab and ipilimumab cannot penetrate and pass an intact blood brain barrier (BBB). In this systematic (...) review we provide a pharmacodynamic and pharmacokinetic consideration of the clinical activity of the immune checkpoint inhibitors nivolumab and ipilimumab in melanoma brain metastases.Pubmed was systematically searched for prospective phase II and III studies on nivolumab and ipilimumab in melanoma brain metastases and cerebrospinal fluid (CSF) levels of nivolumab and ipilimumab. Results were discussed and a perspective on the pharmacodynamics and pharmacokinetics for the intracranial activity

2019 BMC Cancer PubMed abstract

18. Nivolumab with ipilimumab for untreated advanced renal cell carcinoma

Nivolumab with ipilimumab for untreated advanced renal cell carcinoma Niv Nivolumab with ipilimumab for untreated olumab with ipilimumab for untreated advanced renal cell carcinoma advanced renal cell carcinoma T echnology appraisal guidance Published: 15 May 2019 www.nice.org.uk/guidance/ta581 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations (...) and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Nivolumab with ipilimumab for untreated advanced renal cell carcinoma (TA581) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 24Contents Contents 1

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

19. Nivolumab monotherapy or in combination with ipilimumab for metastatic melanoma: systematic review and meta-analysis of randomized-controlled trials. (Abstract)

Nivolumab monotherapy or in combination with ipilimumab for metastatic melanoma: systematic review and meta-analysis of randomized-controlled trials. Nivolumab, a completely human programmed death-1 inhibitor antibody, was first approved by the Food and Drug Administration for patients with advanced malignant melanoma resistant to other modalities of treatment. In 2015, it received approval as the first line of treatment for malignant melanoma. We aimed to synthesize evidence from published (...) randomized-controlled trials on the safety and efficacy of nivolumab, either alone or in combination with ipilimumab, in the management of advanced unresectable melanoma. We searched the following electronic databases: PubMed, Scopus, Web of Science, and Cochrane Central. The records retrieved were screened for eligibility. Time-to-event data were pooled as Hazard ratio using the generic inverse variance method and dichotomous data were pooled as relative risk (RR) in a random-effects model. We used

2019 Melanoma research

20. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial (Full text)

Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial In the ongoing phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunitinib in patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma. We aimed to assess whether health-related quality of life (HRQoL) could be used to further describe (...) the benefit-risk profile of nivolumab plus ipilimumab versus sunitinib.In the phase 3, randomised, controlled, CheckMate 214 trial, patients aged 18 years and older with previously untreated, advanced or metastatic renal cell carcinoma with a clear-cell component were recruited from 175 hospitals and cancer centres in 28 countries. Patients were categorised by risk status into favourable, intermediate, and poor risk subgroups and randomly assigned (1:1) to open-label nivolumab 3 mg/kg plus ipilimumab 1 mg

2019 EvidenceUpdates PubMed abstract