FrancophonIA/ELRC3.0 huggingface dataset:
English: The objective response rate (ORR) was 62.1% (95% CI: 42.3, 79.3) with 4 (14%) of patients reported to have a complete response and 14 (48%) to have a partial response.
Danish: (ORR) var 62,1 % (95 % CI: 42,3; 79,3) hvor der for 4 (14 %) af patienterne blev rapporteret om et komplet respons, og 14 (48 %) havde et partielt respons.
English: Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Danish: Patienterne skal overvåges for hyperglykæmi eller andre tegn og symptomer på diabetes.
English: Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
Danish: Samlet blev det rapporteret, at 52 (59 %) af patienterne havde fået 1 tidligere behandling mod MCC, 26 (30 %) havde fået 2 tidligere behandlinger, og 10 (11 %) havde fået 3 eller flere tidligere behandlinger.
English: • The vial should be visually inspected for particulate matter and discoloration.
Danish: • Hætteglasset skal inspiceres visuelt for partikler og misfarvning.
English: For Part A, the major efficacy outcome measure was confirmed best overall response (BOR); secondary efficacy outcome measures included duration of response (DOR), and progression-free survival (PFS).
Danish: Det primære endepunkt for effekt for del A var det bekræftede bedste samlede respons (best overall response, BOR); sekundære endepunkter for effekt omfattede varigheden af responset (duration of response, DOR) og progressionsfri overlevelse (progression free survival, PFS).
English: • Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: o Immune-Related Pneumonitis o Immune-Related Hepatitis o Immune-Related Colitis o Immune-Related Pancreatitis o Immune-Related Myocarditis o Immune-Related Endocrinopathies (diabetes mellitus, thyroid disorders, adrenal insufficiency) o Immune-related nephritis and renal dysfunction o Other immune-related adverse reactions including myositis, hypopituitarism, uveitis and Guillain-Barre Syndrome o Infusion-Related Reactions
Danish: • Beskrivelse af de vigtigste tegn og symptomer på de følgende sikkerhedsovervejelser, og en påmindelse om vigtigheden af straks at informere den behandlende læge, hvis symptomerne opstår, varer ved eller forværres: o Immunrelateret pneumonitis o Immunrelateret hepatitis o Immunrelateret colitis o Immunrelateret pankreatitis o Immunrelateret myokarditis o Immunrelaterede endokrinopatier (diabetes mellitus, tyreoideasygdomme, binyreinsufficiens) o Immunrelateret nefritis og nyredysfunktion o Andre immunrelaterede bivirkninger, herunder myositis, hypopituitarisme, uveitis og Guillain-Barrés syndrom) o Infusionsrelaterede reaktioner
English: Do not store any unused portion of the concentrate or of the diluted infusion solution for reuse.
Danish: Ubrugte dele af koncentratet eller af den fortyndede infusionsopløsning må ikke opbevares til genbrug.
English: • inflammation of your liver (hepatitis) or other liver problems;
Danish: • leverbetændelse (hepatitis) eller andre leverproblemer,
English: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Danish: Bavencio er indiceret som monoterapi ved behandling af voksne patienter med metastatisk Merkelcelle karcinom (MCC).
English: The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
Danish: Den anbefalede dosis af Bavencio som monoterapi er 800 mg, administreret intravenøst over 60 minutter hver 2. uge.
English: • Increase in the number of a type of white blood cells (eosinophils)
Danish: • Forhøjet antal af en type hvide blodlegemer (eosinofiler)
English: Of 1,738 patients treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks, 1,627 were evaluable for treatment-emergent anti-drug antibodies (ADA) and 96 (5.9%) tested positive.
Danish: Ud af de 1.738 patienter, der blev behandlet med avelumab 10 mg/kg som en intravenøs infusion hver 2. uge, kunne 1.627 evalueres for, om der opstod antidrug-antistoffer (anti-drug antibodies, ADA) under behandlingen, og 96 (5,9 %) blev testet positiv.
English: No clinically important differences in the clearance of avelumab were found between patients with mild (glomerular filtration rate (GFR) 60 to 89 mL/min, Cockcroft-Gault Creatinine Clearance (CrCL); n=623), moderate (GFR 30 to 59 mL/min, n=320) and patients with normal (GFR ≥ 90 mL/min, n=671) renal function.
Danish: Der blev ikke fundet nogen klinisk vigtige forskelle i clearance af avelumab mellem patienter med let (glomerulær filtrationsrate (GFR) 60 til 89 ml/min, Cockcroft-Gault kreatininclearance (CrCL), n = 623), moderat (GFR 30 til 59 ml/min, n = 320) og patienter med normal (GFR ≥ 90 ml/min, n = 671) nyrefunktion.
English: Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Danish: Autoimmun colitis, autoimmun pankreatitis, enterocolitis, ileus, nekrotiserende pankreatitis
English: Permanently discontinue
Danish: Seponer permanent
English: The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Danish: Øvrige indholdsstoffer: Mannitol, koncentreret eddikesyre, polysorbat 20, natriumhydroxid, vand til injektionsvæsker (se punkt 2 ”Bavencio har et lavt natriumindhold”).
English: Median in months (95% CI)
Danish: Median i måneder (95 % CI)
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
English: • inflammation of your muscles (myositis).
Danish: • betændelse i musklerne (myositis).
English: Talk to your doctor before receiving Bavencio:
Danish: Kontakt lægen, før du får Bavencio:
English: Bavencio is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
Danish: Bavencio er et klart, farveløst til let gulligt koncentrat til infusionsvæske, opløsning (koncentrat, sterilt).
English: Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Danish: Data for immunrelaterede bivirkninger for avelumab som monoterapi er baseret på 1.650 patienter i fase I-studiet EMR100070-001 af solide tumorer, og 88 patienter i studie EMR100070-003, og for avelumab i kombination med axitinib er baseret på 489 patienter i studie B9991002 og B9991003 (se pkt.
English: Avelumab should be resumed when the immune-related adverse reaction returns to Grade 1 or less following corticosteroid taper.
Danish: Avelumab bør genoptages, når den immunrelaterede bivirkning falder til grad 1 eller derunder, efter en nedtrapning af kortikosteroider.
English: If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Danish: Hvis opløsningen er afkølet, skal den fortyndede opløsning i de intravenøse poser have stuetemperatur før brug.
English: All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Danish: Alle 31 patienter med immunrelateret hepatitis blev behandlet for hepatitis, herunder 30 (96,8 %) patienter behandlet med kortikosteroider, og 1 patient med et non-steroidt immunosuppressivum.
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately.
Danish: Fra et mikrobiologisk synspunkt bør den fortyndede opløsning infunderes straks, medmindre fortyndingsmetoden udelukker risikoen for mikrobiel kontaminering.
English: Median, months (95% CI)
Danish: Median, måneder (95 % CI)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Bavencio in all subsets of the paediatric population for the treatment of Merkel cell carcinoma and renal cell carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Bavencio i alle undergrupper af den pædiatriske population ved behandling af Merkelcellekarcinom og renalcellekarcinom (se pkt.
English: Complete response (CR) n (%) Partial response (PR) n (%)
Danish: Komplet respons (CR) n (%) Partielt respons (PR) n (%)
English: Nephritis and renal dysfunction
Danish: Nefritis og renaldysfunktion
English: Serious adverse reactions were immune-related adverse reactions and infusion-related reaction (see section 4.4).
Danish: Alvorlige bivirkninger var immunrelaterede bivirkninger og infusionsrelateret reaktion (se pkt.
English: How much Bavencio you will receive
Danish: Så meget Bavencio vil du modtage
English: Results (N=116)
Danish: Resultater (N=116)
English: Lymphopenia, eosinophilia
Danish: Lymfopeni, eosinofili
English: After Part B was fully enrolled, a subsequent interim analysis was conducted with 116 patients who received at least one dose of avelumab and with at least 7 months of follow-up at the time of the data cut-off (cut-off date 14 September 2018).
Danish: Efter del B havde inkluderet alle, blev der udført en efterfølgende interimanalyse med 116 patienter, som fik mindst én dosis af avelumab og med mindst 7 måneders opfølgning på tidspunktet for dataafskæringen (cut-off-dato 14. september 2018).
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: Bavencio contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Danish: Bavencio indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, og derfor er det i det væsentlige natriumfrit.
English: Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Danish: Analysen af progressionsfri overlevelse (PFS) var baseret på 39 patienter, som fik mindst én dosis af avelumab med en median PFS på 9,1 måneder (95 % CI: 1,9 kunne ikke estimeres) og en estimeret PFS-rate efter 3 måneder ved Kaplan-Meier på 67 % (95% CI: 48; 80).
English: Hypothyroidism should be managed with replacement therapy and hyperthyroidism with anti-thyroid medicinal product, as needed.
Danish: Hypotyroidisme skal behandles med erstatningsbehandling med et antityreoidea lægemiddel, efter behov.
English: Patients should be monitored for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria.
Danish: Patienterne skal overvåges for tegn og symptomer på infusionsrelaterede reaktioner, herunder pyreksi, kulderystelser, rødme, hypotension, dyspnø, hvæsende vejrtrækning, rygsmerter, abdominalsmerter og urticaria.
English: Positive (n=46)
Danish: Positiv (n = 46)
English: • Patient Information Brochure
Danish: • Brochure med patientinformation
English: Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Danish: Bavencio i kombination med axitinib er indiceret som førstevalgsbehandling af voksne patienter med fremskredent renalcellekarcinom (RCC) (se pkt.
English: Conditional approval
Danish: Godkendelse under betingede omstændigheder
English: Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.
Danish: Nedsat leverfunktion blev defineret i henhold til kriterierne for leverdysfunktion fra National Cancer Institute (NCI).
English: In patients treated with avelumab in combination with axitinib, Grades 3 and Grade 4 increased ALT and increased AST were reported in 9% and 7% of patients, respectively.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib blev der rapporteret grad 3 og grad 4 forhøjet ALAT og forhøjet ASAT hos hhv. 9 % og 7 % af patienterne.
English: • Increases or decreases in blood pressure
Danish: • Forhøjet eller nedsat blodtryk
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE VILKÅR
English: Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate
Danish: Afbryd, indtil bivirkningerne bedres til grad 0-1, genoptag infusionen med 50 % langsommere hastighed
English: Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment.
Danish: Patienterne skal overvåges for tegn og symptomer på binyreinsufficiens under og efter behandlingen.
English: Response rate, CR+PR** n (%) (95% CI)
Danish: Responsrate, CR+PR** n (%) (95 % CI)
English: This is uncommon.
Danish: Dette er ikke almindeligt.
English: The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Danish: Den præspecificerede interimanalyse for del B omfattede 39 patienter, som fik mindst én dosis af avelumab og 29 patienter med en minumumsopfølgning på 13 uger på tidspunktet for dataafskæringen (cut-off-dato 24. marts 2017).
English: In the supplemental analysis, avelumab CL was found to decrease over time: the largest mean maximal reduction (% coefficient of variation [CV%]) from baseline value with different tumour types was approximately 32.1% (CV 36.2%).
Danish: Den største gennemsnitlige maksimale reduktion (% variationskoefficient [coefficient of variation, CV %]) fra værdien ved baseline med forskellige tumortyper var ca. 32,1 % (CV 36,2 %).
English: Bavencio is a clear, colourless to slightly yellow solution.
Danish: Bavencio er en klar, farveløs til let gullig opløsning.
English: Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids to be administered.
Danish: Baseret på bivirkningens sværhedsgrad, skal avelumab afbrydes, og der skal administreres kortikosteroider.
English: Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Avelumab er et humant, monoklonalt IgG1-antistof rettet mod det immunmodulerende ligandprotein på celleoverfladen, PD-L1.Det fremstilles i ovariecellerne fra kinesiske hamstere ved hjælp af rekombinant dna-teknologi.
English: This is very common.
Danish: Dette er meget almindeligt.
English: Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis
Danish: Grad 3 eller grad 4 pneumonitis eller tilbagevendende grad 2 pneumonitis
English: If the solution is cloudy, discoloured, or contains particulate matters, the vial should be discarded.
Danish: Hvis opløsningen er uklar, misfarvet eller hvis den indeholder partikler, må hætteglasset ikke anvendes.
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Danish: Detaljerede retningslinjer for behandling af immunrelaterede bivirkninger beskrives i pkt.
English: Adverse reactions reported for 489 patients with advanced RCC treated in two clinical studies with avelumab in combination with axitinib are presented in Table 3.
Danish: Bivirkninger rapporteret for 489 patienter med fremskredent RCC behandlet i 2 kliniske studier med avelumab i kombination med axitinib vises i tabel 3.
English: Some side effects may not have symptoms and may only be discovered through blood tests.
Danish: De følgende bivirkninger er blevet indberettet i de kliniske studier med avelumab alene: Nogle bivirkninger har måske ikke symptomer, og kan kun opdages ved blodprøver.
English: Confirmed objective response rate (ORR)
Danish: Bekræftet objektiv responsrate (ORR)
English: This is common.
Danish: Dette er almindeligt.
English: Treatment modification
Danish: Behandlingsmodifikation
English: Reduce infusion rate by
Danish: Reducer infusionshastigheden med
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Danish: Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden
English: Decreased appetite
Danish: Meget almindelig Nedsat appetit Almindelig
English: Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
Danish: En dosisreduktion i henhold til produktinformation for axitinib bør overvejes, hvis axitinib genoptages.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
Danish: Kvinder i den fertile alder skal rådes til at undgå graviditet, mens de får avelumab, og de bør anvende sikker kontraception under behandlingen med avelumab og i mindst 1 måned efter den sidste dosis avelumab.
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of avelumab, including immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, myositis, hypopituitarism, uveitis, GuillainBarre syndrome and infusion related reactions, and how to manage them.
Danish: Uddannelsesprogrammet er beregnet til at øge kendskabet og give oplysninger om tegn og symptomer på visse vigtige identificerede risici ved avelumab, herunder immunrelateret pneumonitis, hepatitis, colitis, pankreatitis, myokarditis, tyreoideasygdomme, binyreinsufficiens, type 1 diabetes mellitus, nefritis og nyredysfunktion, myositis, hypopituitarisme, uveitis, Guillain-Barrés syndrom og infusionsrelaterede reaktioner, og hvordan de skal behandles.
English: Treatment modifications
Danish: Behandlingsmodifikationer
English: Results (N=88)
Danish: Resultater (N = 88)
English: < 1/1,000); very rare (< 1/10,000).
Danish: (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: For patients with Grade 2 infusion-related reactions, the infusion should be temporary discontinued until Grade 1 or resolved, then the infusion will restart with a 50% slower infusion rate (see section 4.2).
Danish: Hos patienter med infusionsrelaterede reaktioner af grad 2 skal infusionen midlertidigt afbrydes, indtil reaktionen er af grad 1 eller er forsvundet, og så kan infusionen påbegyndes igen med en 50 % langsommere infusionshastighed (se pkt.
English: Of the 480 patients with at least one valid ADA result at any time point treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily, 453 were evaluable for treatment-emergent ADA and 66 (14.6%) tested positive.
Danish: Ud af de 480 patienter med mindst et gyldigt ADA-resultat på et vilkårligt tidspunkt, behandlet med avelumab 10 mg/kg som en intravenøs infusion hver 2. uge i kombination med axitinib 5 mg to gange dagligt, kunne 453 evalueres for ADA, som opstod under behandlingen, og 66 (14,6 %) testede positivt.
English: • Signs of inflammation of the muscles (myositis) may include muscle pain or weakness.
Danish: • Tegn på betændelse i musklerne (myositis) kan omfatte muskelsmerter eller svaghed.
English: • Inflammation of the eye
Danish: • Øjenbetændelse
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions.
Danish: I tilfælde af en overdosering, skal patienterne overvåges nøje for tegn og symptomer på bivirkninger.
English: Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
Danish: Tabel 4 opsummerer endepunkter for virkning hos patienter, der fik avelumab ved den anbefalede dosis for studie EMR100070-003, del A, med en minimumsopfølgning på 36 måneder.
English: Figure 1: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part A, minimum follow-up of 36 months)
Danish: Figur 1: Kaplan-Meier-estimater af progressionsfri overlevelse (PFS) pr. RECIST v1.1, IERC (del A, minimumsopfølgning på 36 måneder)
English: Glacial acetic acid Polysorbate 20
Danish: Koncentreret eddikesyre Polysorbat 20
English: The safety of avelumab in combination with axitinib has been evaluated in 489 patients with advanced RCC receiving 10 mg/kg avelumab every 2 weeks and axitinib 5 mg orally twice daily in two clinical studies.
Danish: Avelumabs sikkerhed i kombination med axitinib er blevet evalueret hos 489 patienter med fremskredent RCC, der fik 10 mg/kg avelumab hver 2. uge, og axitinib 5 mg oralt to gange dagligt i 2 kliniske studier.
English: Check with your doctor or nurse before you receive Bavencio if:
Danish: Spørg lægen eller sundhedspersonalet, før du får Bavencio, hvis:
English: Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Danish: Endokrinopatier (hypotyroidisme, hypertyroidisme, adrenal insufficiens, hyperglykæmi)
English: Avelumab should be withheld in the event of suspected immune-related pancreatitis.
Danish: Avelumab bør tilbageholdes i tilfælde af formodet immunrelateret pankreatitis.
English: Dose modification advice for axitinib when used with Bavencio When Bavencio is administered in combination with axitinib, please refer to the axitinib product information for recommended dose modifications for axitinib.
Danish: Anbefaling om dosisjustering for axitinib, når det anvendes sammen med Bavencio Når Bavencio administreres i kombination med axitinib henvises til produktinformationen for axitinib for anbefalinger om dosisjusteringer for axitinib.
English: Negative (n=31)
Danish: Negativ (n = 31)
English: Grade 3 or Grade 4 infusion-related reaction
Danish: Grad 3 eller grad 4 infusionsrelateret reaktion
English: There are insufficient data in patients with severe renal impairment for dosing recommendations.
Danish: Der er ikke tilstrækkelige data for patienter med svært nedsat nyrefunktion til doseringsanbefalinger.
English: If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Danish: Hvis kortikosteroiderne anvendes til at behandle en bivirkning, skal behandlingen med kortikosteroider nedtrappes over mindst 1 måned, efter forbedring er observeret.
English: Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
Danish: Patienter med tidligere systemisk behandling rettet mod fremskredent eller metastatisk RCC; tidligere systemisk immunterapeutisk behandling med IL-2-, IFN-α-, anti-PD-1-, anti-PD-L1- eller anti-CTLA-4-antistoffer eller aktive hjernemetastaser, aktiv autoimmunsygdom, der kan forværres, når der fås immunstimulerende midler, andre tidligere maligniteter i anamnesen inden for de sidste 5 år, organtransplantation, var ikke egnede.