Latest & greatest articles for nivolumab

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Top results for nivolumab

121. Nivolumab (Opdivo) for Hodgkin lymphoma in brentuximab na?ve patients - second line

Nivolumab (Opdivo) for Hodgkin lymphoma in brentuximab na?ve patients - second line Nivolumab (Opdivo) for Hodgkin lymphoma in brentuximab naïve patients – second line Nivolumab (Opdivo) for Hodgkin lymphoma in brentuximab naïve patients – second 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. Citation NIHR HSRIC. Nivolumab (Opdivo) for Hodgkin lymphoma (...) in brentuximab naïve patients – second line. Birmingham: NIHR Horizon Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 Authors' objectives Hodgkin lymphoma is a cancer of the lymphatic system – part of the body's immune system. In Hodgkin lymphoma, blood cells called lymphocytes become abnormal, increase in number and collect in the lymph nodes (glands) and other organs. Nivolumab is a new antibody drug for the treatment of Hodgkin lymphoma, and is delivered straight into the bloodstream

2015 Health Technology Assessment (HTA) Database.

122. Nivolumab (Opdivo) for diffuse large B cell lymphoma -second line

Nivolumab (Opdivo) for diffuse large B cell lymphoma -second line Nivolumab (Opdivo) for diffuse large B cell lymphoma –second line Nivolumab (Opdivo) for diffuse large B cell lymphoma –second 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. Citation NIHR HSRIC. Nivolumab (Opdivo) for diffuse large B cell lymphoma –second line. Birmingham: NIHR Horizon (...) Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 Authors' objectives Lymphoma is a cancer of the lymphatic system, which is part of the immune system. It contains cells called lymphocytes that fight infections. Diffuse large B cell lymphoma is the most common type of non-Hodgkin's lymphoma. It can occur at any age but is more common in those over 65 years of age. Nivolumab is a new antibody drug for the treatment of diffuse large B cell lymphoma and is delivered straight

2015 Health Technology Assessment (HTA) Database.

123. Nivolumab (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment)

Nivolumab (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 2015). 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. A15-32 Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-32 Version 1.0 Nivolumab (new TI) – Benefit assessment acc. to §35a Social Code Book V 12 Nov 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab (new therapeutic indication) – Benefit assessment according to §35a SGB V Commissioning

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

124. Nivolumab: benefit assessment according to §35a Social Code Book V (dossier assessment)

Nivolumab: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Nivolumab – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 2015). 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. A15-27 Nivolumab – Benefit assessment (...) according to §35a Social Code Book V 1 Extract of dossier assessment A15-27 Version 1.0 Nivolumab – Benefit assessment acc. to §35a Social Code Book V 13 October 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Nivolumab – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 July 2015 Internal Commission No.: A15-27

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

125. Nivolumab (Opdivo) for first-line treatment of advanced melanoma

Nivolumab (Opdivo) for first-line treatment of advanced melanoma Nivolumab (Opdivo) for first-line treatment of advanced melanoma Nivolumab (Opdivo) for first-line treatment of advanced melanoma HAYES, Inc. 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. Citation HAYES, Inc.. Nivolumab (Opdivo) for first-line treatment of advanced melanoma. Lansdale: HAYES, Inc

2015 Health Technology Assessment (HTA) Database.

126. Opdivo - nivolumab

Opdivo - nivolumab 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 5520 Send a question via our website www.ema.europa.eu/contact 23 April 2015 EMA/CHMP/76688/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report OPDIVO International non-proprietary name: nivolumab Procedure No. EMEA/H/C/003985/0000 Note Assessment report as adopted by the CHMP with all information (...) of a commercially confidential nature deleted. Assessment report EMA/CHMP/76688/2015 Page 2/130 Administrative information Name of the medicinal product: OPDIVO Applicant: Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM Active substance: nivolumab International Nonproprietary Name/Common Name: nivolumab Pharmaco-therapeutic group (ATC Code): L01XC17 Therapeutic indication(s): OPDIVO as monotherapy is indicated for the treatment of advanced (unresectable

2015 European Medicines Agency - EPARs

127. Nivolumab BMS

Nivolumab BMS EMA/351429/2015 EMEA/H/C/003840 EPAR summary for the public Nivolumab BMS nivolumab This is a summary of the European public assessment report (EPAR) for Nivolumab BMS. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Nivolumab BMS. For practical information about using Nivolumab BMS, patients should read the package leaflet or contact their doctor (...) or pharmacist. What is Nivolumab BMS and what is it used for? Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC). It is used in patients whose disease has spread locally or to other parts of the body and who have previously been treated with other cancer medicines (chemotherapy). The medicine contains the active substance nivolumab. How is Nivolumab BMS used? Nivolumab BMS can only be obtained with a prescription

2015 European Medicines Agency - EPARs

128. Nivolumab in Previously Untreated Melanoma without BRAF Mutation. (PubMed)

Nivolumab in Previously Untreated Melanoma without BRAF Mutation. Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study.We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (...) (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival.At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42

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2014 NEJM

129. Opdivo (nivolumab) - To treat patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs

Opdivo (nivolumab) - To treat patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Opdivo (nivolumab) Injection Company: Bristol-Myers Squibb Company Application No.: 125554 Approval Date: 12/22/2014 Persons with disabilities having problems accessing the PDF files below may

2014 FDA - Drug Approval Package

130. Nivolumab for advanced melanoma ? second or third line

Nivolumab for advanced melanoma ? second or third line Nivolumab for advanced melanoma – second or third line Nivolumab for advanced melanoma – second or third 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 of this assessment has been made for the HTA database. Citation NIHR HSC. Nivolumab for advanced melanoma – second or third line. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC

2014 Health Technology Assessment (HTA) Database.

131. Nivolumab for BRAF V600 mutation? negative advanced melanoma ? first line

Nivolumab for BRAF V600 mutation? negative advanced melanoma ? first line Nivolumab for BRAF V600 mutation– negative advanced melanoma – first line Nivolumab for BRAF V600 mutation– negative advanced melanoma – 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 of this assessment has been made for the HTA database. Citation NIHR HSC. Nivolumab for BRAF V600 mutation– negative advanced

2014 Health Technology Assessment (HTA) Database.

132. Nivolumab for BRAF V600 mutation-positive advanced melanoma ? first line

Nivolumab for BRAF V600 mutation-positive advanced melanoma ? first line Nivolumab for BRAF V600 mutation-positive advanced melanoma – first line Nivolumab for BRAF V600 mutation-positive advanced melanoma – 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 of this assessment has been made for the HTA database. Citation NIHR HSC. Nivolumab for BRAF V600 mutation-positive advanced

2014 Health Technology Assessment (HTA) Database.

133. Nivolumab with ipilimumab for advanced melanoma ? first line

Nivolumab with ipilimumab for advanced melanoma ? first line Nivolumab with ipilimumab for advanced melanoma – first line Nivolumab with ipilimumab for advanced melanoma – 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 of this assessment has been made for the HTA database. Citation NIHR HSC. Nivolumab with ipilimumab for advanced melanoma – first line. Birmingham: NIHR Horizon

2014 Health Technology Assessment (HTA) Database.

134. Nivolumab for advanced or metastatic clear-cell renal cell carcinoma ? second or third line

Nivolumab for advanced or metastatic clear-cell renal cell carcinoma ? second or third line Nivolumab for advanced or metastatic clear-cell renal cell carcinoma – second or third line Nivolumab for advanced or metastatic clear-cell renal cell carcinoma – second or third 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 of this assessment has been made for the HTA database. Citation NIHR (...) HSC. Nivolumab for advanced or metastatic clear-cell renal cell carcinoma – second or third 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; Antineoplastic Agents; Carcinoma, Renal Cell; Kidney Neoplasmss; Programmed Cell Death 1 Receptor; Survival Rate Language Published English Country of organisation England English summary An English language summary

2014 Health Technology Assessment (HTA) Database.

135. Nivolumab for non-small cell lung cancer ? second line

Nivolumab for non-small cell lung cancer ? second line Nivolumab for non-small cell lung cancer – second line Nivolumab for non-small cell lung cancer – second 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 of this assessment has been made for the HTA database. Citation NIHR HSC. Nivolumab for non-small cell lung cancer – second line. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC

2013 Health Technology Assessment (HTA) Database.

136. Nivolumab plus ipilimumab in advanced melanoma. (PubMed)

Nivolumab plus ipilimumab in advanced melanoma. In patients with melanoma, ipilimumab (an antibody against cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4]) prolongs overall survival, and nivolumab (an antibody against the programmed death 1 [PD-1] receptor) produced durable tumor regression in a phase 1 trial. On the basis of their distinct immunologic mechanisms of action and supportive preclinical data, we conducted a phase 1 trial of nivolumab combined with ipilimumab in patients (...) with advanced melanoma.We administered intravenous doses of nivolumab and ipilimumab in patients every 3 weeks for 4 doses, followed by nivolumab alone every 3 weeks for 4 doses (concurrent regimen). The combined treatment was subsequently administered every 12 weeks for up to 8 doses. In a sequenced regimen, patients previously treated with ipilimumab received nivolumab every 2 weeks for up to 48 doses.A total of 53 patients received concurrent therapy with nivolumab and ipilimumab, and 33 received

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2013 NEJM