natgillin/translations-raw huggingface dataset:
Pembrolizumabs sikkerhed som monoterapi er blevet vurderet hos 5.884 patienter med fremskredent melanom, resekteret stadie III-melanom (adjuverende behandling), NSCLC, cHL, urotelialt karcinom eller HNSCC ved 4 doser (2 mg/kg hver 3. uge, 200 mg hver 3. uge eller 10 mg/kg hver 2. eller 3. uge) i kliniske studier. 
The safety of pembrolizumab as monotherapy has been evaluated in 5,884 patients with advanced melanoma, resected Stage III melanoma (adjuvant therapy), NSCLC, cHL, urothelial carcinoma, or HNSCC across four doses (2 mg/kg every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg every 2 or 3 weeks) in clinical studies.
Ved forhøjede leverenzymer hos RCC-patienter, der behandles med KEYTRUDA i kombination med axitinib: 
For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib:
Hos patienter med HNSCC, som blev behandlet med pembrolizumab som monoterapi (n=909), var forekomsten af hypotyroidisme 16,1% (alle grader) med 0,3% af grad 3. 
In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3.
Forhøjede leverenzymer, når pembrolizumab anvendes i kombination med axitinib ved RCC I et klinisk studie af tidligere ubehandlede RCC-patienter, der fik pembrolizumab i kombination med axitinib, blev der observeret en højere end forventet forekomst af grad 3 og 4 forhøjelser af ALAT (20%) og ASAT (13%). 
Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC In a clinical study of previously untreated patients with RCC receiving pembrolizumab in combination with axitinib, a higher than expected incidence of Grades 3 and 4 ALT increased (20%) and AST increased (13%) were observed.
Pneumonitis medførte seponering af pembrolizumab hos 98 (1,7%) patienter. 
Pneumonitis led to discontinuation of pembrolizumab in 98 (1.7%) patients.
Den mediane tid til indtræden af pneumonitis var 3,3 måneder (interval: 2 dage til 26,8 måneder). 
The median time to onset of pneumonitis was 3.3 months (range 2 days to 26.8 months).
Almindelig influenzalignende sygdom, kuldegysninger kuldegysninger, influenzalignende sygdom ødem aa 
Common influenza like illness, chills chills, influenza-like illness oedema aa
Ud af 540 patienter var 61% mænd, 43% var ≥ 65 år (medianalderen var 62 år [interval: 15-89]), og 98% var kaukasere. 
Of the 540 patients, 61% were male, 43% were ≥ 65 years (median age was 62 years [range 15-89]) and 98% were white.
Baseline-karakteristika for denne population inkluderede: medianalder 63 år (42% i alderen 65 år eller ældre); 61% mænd; 72% kaukasere og 21% asiater og henholdsvis 34% og 66% med ECOGperformance-status 0 og 1. 
The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively.
Colitis gik over hos 84 patienter, 2 med sequelae. 
Colitis resolved in 84 patients, 2 with sequelae.
Tabel 17: Respons på pembrolizumab 2 eller 10 mg/kg hver 3. uge hos tidligere behandlede patienter med NSCLC i KEYNOTE-010 
Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010
• Før fortynding kan hætteglasset med koncentrat opbevares uden for køleskab (ved temperaturer på eller under 25 °C) i op til 24 timer. 
• Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
I tabel 9 opsummeres effektresultaterne ud fra PD-L1-ekspression. 
Table 9 summarizes efficacy results by PD-L1 expression.
Kemoterapi (n=42) 
Chemotherapy (n=42)
Medianvarigheden blev ikke nået (interval: 2 dage til 32,6+ måneder). 
The median duration was not reached (range 2 days to 32.6+ months).
Medianvarigheden var 3,3 måneder (interval: 3 dage til 18,1+ måneder). 
The median duration was 3.3 months (range 3 days to 18.1+ months).
Almindelig svimmelhed, perifer neuropati, letargi, dysgeusi letargi svimmelhed, letargi, perifer neuropati 
Common dizziness, neuropathy peripheral, lethargy, dysgeusia lethargy dizziness, lethargy, neuropathy peripheral
I tabel 8 opsummeres effektresultaterne ud fra PD-L1-ekspression. 
Table 8 summarises efficacy results by PD-L1 expression.
81% havde en primær tumor i den nederste del af urinvejene, og 19% havde en primær tumor i de øvre urinveje. 
Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract.
Patienterne blev randomiseret i forholdet 1:1 til en af følgende behandlingsarme med intravenøs infusion: 
Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion:
Standardbehandling* n=110 
Standard Treatment* n=110
Patienterne blev stratificeret ud fra PD-L1-tumorekspression (TPS ≥ 50%), HPV-status og ECOG-performance-status og blev herefter randomiseret i forholdet 1:1 til at få enten pembrolizumab 200 mg hver 3. uge (n=247) eller en af tre standardbehandlinger (n=248): methotrexat 40 mg/m2 en gang ugentligt (n=64), docetaxel 75 mg/m2 en gang hver 3. uge (n=99) eller cetuximab 400 mg/m 2 støddosis og herefter 250 mg/m 2 en gang ugentligt (n=71). 
Patients were stratified by PD-L1 expression (TPS ≥ 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks
Den mediane tid til indtræden af forhøjet ALAT var 2,3 måneder (interval: 7 dage til 19,8 måneder). 
The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months).
Standardbehandling* n=65 
Standard Treatment* n=65
Træthed er rapporteret efter administration af pembrolizumab (se pkt. 
Fatigue has been reported following administration of pembrolizumab (see section 4.8).
Der blev udført en subgruppeanalyse som en del af den endelige analyse i KEYNOTE-006 hos patienter, som var enten BRAF vildtype (n=525; 63%), BRAF-mutation uden forudgående BRAF-behandling (n=163; 20%) eller BRAF-mutation med forudgående BRAF-behandling (n=139; 17%) som opsummeret i tabel 7. 
A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7.
Objektiv responsrate* ORR %, (95% CI) OS 
Objective Response Rate* ORR %, (95% CI) OS
KEYTRUDA som monoterapi er indiceret til adjuverende behandling af voksne med stadie III-melanom og lymfeknudeinvolvering, som har fået foretaget komplet resektion (se pkt. 
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection (see section 5.1).
(pneumonitis) - hvis du tidligere har fået ipilimumab, der er et andet lægemiddel til behandling af melanom, og har oplevet alvorlige bivirkninger på grund af dette lægemiddel - hvis du har haft en allergisk reaktion ved behandling med andre monoklonale antistoffer - hvis du har eller har haft en kronisk virusinfektion i leveren, herunder hepatitis B (hbv) eller hepatitis C (hcv) - hvis du har hiv- (human immundefekt virus) infektion eller aids (erhvervet immundefekt syndrom) - hvis du har leverskader - hvis du har nyreskader - hvis du har gennemgået en transplantation af et fast organ eller en knoglemarvstransplantation 
Before you get KEYTRUDA, tell your doctor if you: - have an autoimmune disease (a condition where the body attacks its own cells) - have pneumonia or inflammation of your lungs (called pneumonitis) - were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine - had an allergic reaction to other monoclonal antibody therapies - have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV) - have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) - have liver damage - have kidney damage - have had a solid organ transplant or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic)
Tabel 11: Effektresultater ud fra PD-L1-ekspression og BRAF-mutationsstatus i KEYNOTE-054 
Table 11: Efficacy results by PD-L1 expression and BRAF mutation status in KEYNOTE-054
Blandt de 495 patienter i KEYNOTE-040 havde 129 (26%) tumorer, der udtrykte PD-L1 med TPS ≥ 50% baseret på PD-L1 IHC 22C3 pharmDx 
Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS ≥ 50% based on the PD-L1 IHC 22C3 pharmDx
Kemoterapi n=151 
Chemotherapy n=151
Hos patienter med NSCLC, hvis tumorer har høj PD-L1-ekspression, skal risikoen for bivirkninger med kombinationsbehandling i forhold til pembrolizumab monoterapi overvejes og benefit/risk-forholdet for den kombinerede behandling vurderes på individuel basis (se pkt. 
In patients with NSCLC whose tumours have high PD-L1 expression, the risk of adverse reactions with combination therapy relative to pembrolizumab monotherapy should be considered and the benefit/risk ratio of the combined therapy evaluated on an individual basis (see sections 4.1, 4.4, 4.8 and 5.1).
Hos de 616 patienter i KEYNOTE-189 var baseline-karakteristika: medianalder 64 år (49% i alderen 65 år eller ældre); 59% mænd; 94% kaukasere og 3% asiater; henholdsvis 43% og 56% med ECOGperformance-status 0 eller 1; 31% PD-L1-negative (TPS < 1%); og 18% med behandlede eller ikke behandlede hjernemetastaser ved baseline. 
Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline.
Tabel 28: Effektresultater i KEYNOTE-426 
Table 28: Efficacy Results in KEYNOTE-426
Sekundære resultatmål var ORR og responsvarighed. 
Secondary efficacy outcome measures were ORR and response duration.
Almindelig colitis n, mundtørhed colitis n, mundtørhed colitis n, mundtørhed 
Common colitis n, dry mouth colitis n, dry mouth colitis n, dry mouth
Patienterne blev behandlet med pembrolizumab indtil uacceptabel toksicitet eller sygdomsprogression. 
Patients were treated with pembrolizumab until unacceptable toxicity or disease progression.
Median i måneder (95% CI) PFS 
Median in months (95% CI) PFS
Samlet responsrate Samlet responsrate (95% CI) Komplet respons % Partielt respons % p-værdi 
Overall Response Rate Overall response rate (95% CI) Complete response % Partial response % p-Value
Brug af pembrolizumab hos patienter med urotelialt karcinom, som tidligere har fået platinbaseret kemoterapi 
Use of pembrolizumab in urothelial carcinoma patients who have received prior platinum-containing chemotherapy
Pembrolizumab + Axitinib versus Sunitinib 
Pembrolizumab + Axitinib vs. Sunitinib
Yderligere eksklusionskriterier var en anamnese med svære eller livstruende immunrelaterede bivirkninger som følge af behandling med ipilimumab, defineret som en hvilken som helst grad 4-toksicitet eller en grad 3-toksicitet, som krævede behandling med kortikosteroider (> 10 mg prednison dagligt eller en dosis ækvivalent hermed) i mere end 12 uger; igangværende bivirkninger ≥ grad 2 fra tidligere behandling med ipilimumab; patienter, der tidligere har haft svær overfølsomhed over for andre monoklonale antistoffer; patienter med pneumonitis eller interstitiel lungesygdom i anamnesen; patienter med hiv-, hepatitis B- eller hepatitis C-infektion og ECOG-performance-status ≥ 2. 
The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immunerelated adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions ≥ Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status ≥ 2.
HR* for RFS (95% CI) RFS-rate ved måned 6 
RFS Hazard ratio* (95% CI) RFS rate at 6 months
Der var ingen betydningsfuld indvirkning på forplantningsorganerne hos han- og hunaber i toksicitetsstudier af 1 måned og 6 måneders varighed med gentagne doser. 
There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat dose toxicity studies (see section 5.3).
træthed eller brystsmerter; betændelse i hjertesækken - ændret hårfarve; tør, kløende hud; små buler eller sår på huden. 
feeling tired, or chest pain; inflammation of the covering of the heart - hair colour changes; dry, itchy skin; small skin bumps, lumps or sores
Patienter med klinisk signifikant nedsat nyrefunktion (kreatinin > 1,5 x ULN) eller leverfunktion (bilirubin > 1,5 x ULN, ALAT, ASAT > 2,5 x ULN med fravær af levermetastaser) ved baseline blev ekskluderet fra kliniske studier. 
Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical trials, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment.
Retningslinjerne for medicinsk behandling for begge lægemidler skal følges (se pkt. 
Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib).
KEYTRUDA, i kombination med pemetrexed og platinbaseret kemoterapi, er indiceret til førstelinjebehandling af metastatisk ikke-planocellulær NSCLC hos voksne uden EGFR- eller ALKpositive mutationer i tumorer. 
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the firstline treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Patienter med aktiv autoimmun sygdom eller lidelser, som krævede behandling med immunsuppressiva, eller slimhindemelanom eller okulært melanom var uegnede til studiet. 
Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible.
Behandlingen med pembrolizumab og axitinib fortsatte indtil sygdomsprogression defineret i henhold til RECIST v1.1 baseret på BICR-vurdering eller bekræftet af investigator, uacceptabel toksicitet, eller for for pembrolizumab, i højst 24 måneder. 
Treatment with pembrolizumab and axitinib continued until RECIST v1.1-defined progression of disease as verified by BICR or confirmed by the investigator, unacceptable toxicity, or for pembrolizumab, a maximum of 24 months.
Karakteristika for studiepopulationen var: medianalder på 62 år (interval: 26 til 90); 38% i alderen 65 år eller ældre; 73% mænd; 79% kaukasere og 16% asiatere; 80% havde en Karnofsky Performance-Score (KPS) på 90-100, og 20% havde en KPS på 70-80; patientfordelingen ifølge IMDC-risikokategorier var 31% lav risiko, 56% middel risiko og 13% høj risiko. 
The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor.
Den samlede opbevaringstid på 96 timer efter rekonstitution kan inkludere opbevaring i op til 6 timer ved stuetemperatur (ved eller under 25 °C). 
This 96 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°C).
Den mediane tid til indtræden af hypertyroidisme var 1,4 måneder (interval: 1 dag til 22,5 måneder). 
The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 22.5 months).
Patienterne havde PD-L1ekspression med tumour proportion score (TPS)  50% baseret på PD-L1 IHC 22C3 pharmDx 
Patients had PD-L1 expression with a  50% tumour proportion score (TPS) based on the PD-L1 IHC 22C3 pharmDx
Pembrolizumabs sikkerhed og virkning blev undersøgt i KEYNOTE-040, et åbent, randomiseret, kontrolleret multicenterstudie til behandling af histologisk bekræftet recidiverende eller metastatisk HNSCC i mundhulen, svælget (farynx) eller struben (larynx) hos patienter, som havde sygdomsprogression under eller efter platinbaseret kemoterapi administreret til behandling af recidiverende eller metastatisk HNSCC eller efter platinbaseret kemoterapi administreret som en del af induktionsbehandling, samtidig behandling eller adjuverende behandling, og som ikke var modtagelige for lokal kurativt intenderet behandling. 
The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, openlabel, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent.
• KEYTRUDA 200 mg hver 3. uge 
• KEYTRUDA 200 mg every 3 weeks
Almindelig trombocytopeni, lymfopeni febril neutropeni, leukopeni, lymfopeni anæmi, neutropeni, leukopeni, trombocytopeni 
Common thrombocytopaenia, lymphopaenia febrile neutropaenia, leukopaenia, lymphopaenia anaemia, neutropaenia, leukopaenia, thrombocytopaenia
4. kvartal 2023 
4Q 2023
Efter rekonstitution indeholder 1 ml koncentrat 25 mg pembrolizumab. 
After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.
Behandling med pembrolizumab fortsatte indtil sygdomsprogression defineret i henhold til RECIST 1.1 efter investigators vurdering, uacceptabel toksicitet eller i højst 24 måneder. 
Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months.
Sjælden immun trombocytopenisk purpura, hæmolytisk anæmi, ren erytrocyt aplasi, hæmofagocytisk lymfohistiocytose eosinofili 
Rare immune thrombocytopenic purpura, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis eosinophilia
• Træk det påkrævede volumen (op til 4 ml (100 mg)) koncentrat op og overfør det til en intravenøs infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9%) eller glucose 50 mg/ml (5%) for at fremstille den færdige infusionsvæske med en endelig koncentration på 1 til 10 mg/ml. 
• Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
• Lad hætteglasset opnå stuetemperatur (ved temperaturer på eller under 25 °C). 
• Equilibrate the vial to room temperature (at or below 25°C).
Kemoterapi: 
Chemotherapy:
Pembrolizumabs sikkerhed og virkning blev vurderet i KEYNOTE-045, et randomiseret (1:1), kontrolleret multicenterstudie til behandling af lokalt fremskredent eller metastatisk urotelialt karcinom hos patienter med sygdomsprogression ved eller efter platinbaseret kemoterapi. 
The safety and efficacy of pembrolizumab were evaluated in KEYNOTE-045, a multicentre, randomised (1:1), controlled study for the treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression on or after platinum-containing chemotherapy.
Den mediane tid til indtræden af nefritis var 5,0 måneder (interval: 12 dage til 21,4 måneder). 
The median time to onset of nephritis was 5.0 months (range 12 days to 21.4 months).
erytem, tør hud alvorlige hudreaktioner s, 
Common severe skin reactions s,
Patienter med lette eller moderate infusionsreaktioner kan fortsætte med at få pembrolizumab under tæt monitorering. 
Patients with mild or moderate infusion reaction may continue to receive pembrolizumab with close monitoring; premedication with antipyretic and antihistamine may be considered.
Den mediane opfølgningstid var 7,8 måneder (interval: 0,1 til 19,1 måneder). 
The median follow-up time was 7.8 months (range: 0.1 to 19.1 months).
Median i måneder (95% CI) Objektiv responsrate ORR % (95% CI) p-værdi 
Median in months (95% CI) Objective Response Rate ORR % (95% CI) p-Value
#) patienter med varighed ≥ 12 måneder 
#) of patients with duration ≥ 12 months
Ikke almindelig perikardieeffusion, perikarditis perikardieeffusion myokarditis 
Uncommon pericardial effusion, pericarditis pericardial effusion myocarditis
Der blev foretaget vurdering af tumorstatus ved baseline, efter randomiseringen i uge 12, herefter hver 6. uge indtil uge 54, og herefter hver 12. uge. 
Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter.
Der blev ikke påvist klinisk betydningsfulde forskelle i pembrolizumabs clearance mellem patienter med let eller moderat nedsat nyrefunktion og patienter med normal nyrefunktion. 
No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate renal impairment and patients with normal renal function.
Karakteristika for studiepopulationen var: medianalder på 65 år (interval: 29 til 88); 55% i alderen 65 år eller ældre; 81% mænd; 77% kaukasere; ECOG-performance status 0 (29%) og 1 (71%); og 8% med behandlede hjernemetastaser ved baseline. 
The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline.
Den mediane tid til indtræden af hepatitis var 3,6 måneder (interval: 8 dage til 21,4 måneder). 
The median time to onset of hepatitis was 3.6 months (range 8 days to 21.4 months).
Placebo + pemetrexed + platinbaseret kemoterapi n=206 
Placebo + Pemetrexed + Platinum Chemotherapy n=206
Responsvarighed Median i måneder (interval) % med varighed ≥ 6 måneder 
Duration of Response Median in months (range) % with duration ≥6 months
Lægen bør overveje benefit/risk-forholdet for de tilgængelige behandlingsmuligheder (pembrolizumab som monoterapi eller pembrolizumab i kombination med kemoterapi), før behandling initieres hos patienter med planocellulært hoved-hals karcinom, hvis tumorer udtrykker PD-L1 (se pkt. 
Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in patients with head and neck squamous cell carcinoma whose tumours express PD-L1 (see section 5.1).
Hver ml koncentrat indeholder 25 mg pembrolizumab. 
Each mL of concentrate contains 25 mg of pembrolizumab.
Patienterne blev behandlet med pembrolizumab indtil sygdomsprogression eller uacceptabel toksicitet. 
Patients were treated with pembrolizumab until disease progression or unacceptable toxicity.
Vurdering af tumorstatus blev foretaget 9 uger efter første dosis, derefter hver 6. uge i det første år, og efterfølgende hver 12. uge. 
Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter.
84% havde melanom i M1c-stadiet, og 8% af patienterne havde hjernemetastaser i anamnesen. 
Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases.
Okulært melanom 
Ocular melanoma
• en bestemt type nyrekræft kaldet renalcellekarcinom. 
• a kind of kidney cancer called renal cell carcinoma.
Den mediane tid til indtræden af hypotyroidisme var 3,5 måneder (interval: 1 dag til 19,6 måneder). 
The median time to onset of hypothyroidism was 3.5 months (range 1 day to 19.6 months).