Latest & greatest articles for nivolumab

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Top results for nivolumab

1. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial

Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features (...) Share Permalink Copy Page navigation Lancet Oncol Actions . 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial , , , , , , , , , , , , , , , , , , , , , , , , , , Affiliations Expand Affiliations 1 Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. Electronic address

2020 EvidenceUpdates

2. Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy

Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy T echnology appraisal guidance Published: 21 October 2020 www.nice.org.uk/guidance/ta655 © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Your responsibility Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after (...) 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 for advanced squamous non-small-cell lung cancer after chemotherapy (TA655) © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 18Contents Contents 1 Recommendations 4 2 Information about nivolumab 6

2020 National Institute for Health and Clinical Excellence - Technology Appraisals

3. Nivolumab (Opdivo) plus ipilimumab (Yervoy) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC)

Nivolumab (Opdivo) plus ipilimumab (Yervoy) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) Nivolumab (Opdivo®) plus ipilimumab (Yervoy®) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) - Repository of AIHTA GmbH English | Browse - - - Nivolumab (Opdivo®) plus ipilimumab (Yervoy®) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) Grössmann, N. (2020): Nivolumab (Opdivo®

2020 Austrian Institute of Health Technology Assessment

4. Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study

Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Clipboard, Search History, and several other advanced features are temporarily unavailable. National (...) Name of RSS Feed: Number of items displayed: Create RSS Cancel RSS Link Copy Actions Cite Share Permalink Copy Page navigation J Clin Oncol Actions . 2020 Jun 1;38(16):1814-1823. doi: 10.1200/JCO.19.02059. Epub 2020 Apr 10. Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study , , , , , , , , , , , , , Affiliations Expand Affiliations 1 Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York

2020 EvidenceUpdates

5. 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

6. 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)

7. 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

8. 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)

9. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. Full Text available with Trip Pro

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

10. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. Full Text available with Trip Pro

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

11. 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)

12. 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

13. 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

14. 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 available with Trip Pro

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

15. Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease

Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease Niv Nivolumab for adjuvant treatment of olumab for adjuvant treatment of completely resected melanoma with completely resected melanoma with lymph node in lymph node inv volv olvement or metastatic ement or metastatic disease disease T echnology appraisal guidance Published: 23 January 2019 nice.org.uk/guidance/ta558 © NICE 2019. All rights reserved. Subject to Notice of rights (...) . They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity 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 for adjuvant treatment of completely resected melanoma with lymph node involvement

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

16. Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V

Nivolumab (melanoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Nivolumab (Melanom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 November 2018). Please note: This document was translated by an external translator and 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. A18-53 Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-53 Version 1.0 Nivolumab (melanoma) 29 November 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (melanoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27 August 2018

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

17. Nivolumab (Opdivo) - melanoma

Nivolumab (Opdivo) - melanoma 1 Published 10 December 2018 1 SMC2112 nivolumab 10mg/mL concentrate for solution for infusion (Opdivo®) Bristol-Myers Squibb Pharmaceuticals Limited 9 November 2018 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 nivolumab (Opdivo ® ) is accepted for use (...) within NHSScotland. Indication under review: As monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Adjuvant treatment with nivolumab improved recurrence free survival compared with another immunotherapy in adults with melanoma with involvement of lymph nodes or metastatic disease who had undergone complete resection. SMC advice takes account of the benefit of Patient Access Schemes (PAS

2018 Scottish Medicines Consortium

18. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial (Abstract)

Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial Previously reported results from the phase 3 CheckMate 067 trial showed a significant improvement in objective responses, progression-free survival, and overall survival with nivolumab plus ipilimumab or nivolumab alone compared with ipilimumab alone in patients with advanced melanoma. The aim of this report is to provide 4-year (...) updated efficacy and safety data from this study.In this phase 3 trial, eligible patients were aged 18 years or older with previously untreated, unresectable, stage III or stage IV melanoma, known BRAFV600 mutation status, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned 1:1:1 to receive intravenous nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses, followed by nivolumab 3 mg/kg every 2 weeks, or nivolumab 3 mg/kg every 2

2018 EvidenceUpdates

19. Diffuse alveolar hemorrhage with pseudoprogression during nivolumab therapy in a patient with malignant melanoma Full Text available with Trip Pro

Diffuse alveolar hemorrhage with pseudoprogression during nivolumab therapy in a patient with malignant melanoma Nivolumab, an anti-PD-1 antibody, has been shown to be effective in many cancers, such as malignant melanoma and lung cancer; however, nivolumab therapy can result in pseudoprogression. Diffuse alveolar hemorrhage (DAH) is persistent or recurrent pulmonary hemorrhage as a result of drugs, autoimmune diseases, or infections. DAH with pseudoprogression during nivolumab administration (...) has rarely been reported. Herein, we describe our experience with one such case. A 41-year-old woman exhibited bloody sputum and ground glass opacities in the lungs along with tumor growth during nivolumab therapy for multiple lung metastases of malignant melanoma. We diagnosed DAH with pseudoprogression as a result of nivolumab and administered steroid therapy. The DAH subsequently improved and the tumor shrank. This case illustrates that nivolumab can cause DAH with pseudoprogression, which can

2018 Thoracic cancer

20. Nivolumab (Opdivo) - to treat stomach cancer, including cancers that occur at the junction of the stomach and oesophagus

Nivolumab (Opdivo) - to treat stomach cancer, including cancers that occur at the junction of the stomach and oesophagus 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 27 July 2018 EMA/504630/2018 EMEA/H/C/003985/II/0039 (...) Withdrawal of application for a change to the marketing authorisation for Opdivo (nivolumab) On 27 June 2018, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new use of Opdivo for the treatment of stomach cancer. What is Opdivo? Opdivo is a cancer medicine currently authorised to treat the following cancers: melanoma (skin cancer), non-small cell lung cancer, renal cell carcinoma (kidney cancer

2018 European Medicines Agency - EPARs