Nivolumab, BMS-936558 i kombination med Relatlimab, BMS-986016 hos patienter med metastatisk melanom, der er naive over for tidligere immunterapi i metastaserende omgivelser
24. august 2026 opdateret af: John Kirkwood
Et fase II-studie af anti-PD1 monoklonalt antistof (Nivolumab, BMS-936558) administreret i kombination med anti-LAG3 monoklonalt antistof (Relatlimab, BMS-986016) hos patienter med metastatisk melanom, der er naive til tidligere immunterapi i metastatiske omgivelser
Hovedmålet med denne undersøgelse er at evaluere antitumoraktiviteten af relatlimab og nivolumab i kombination hos personer med inoperabelt eller metastatisk melanom, som ikke har modtaget tidligere behandling med immunterapi.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse vil evaluere antitumoraktiviteten af anti-LAG3 monoklonalt antistof relatlimab og anti-PD1 monoklonalt antistof nivolumab i kombination hos forsøgspersoner med inoperabelt eller metastatisk melanom, som ikke har modtaget tidligere behandling med immunterapi.
Forsøget er designet med en indledende fase på 2 cyklusser (4 uger) behandling af enten nivolumab, relatlimab eller kombinationen af nivolumab/relatlimab, efterfulgt af en kombinationsfase med nivolumab/relatlimab behandling i alle forsøgspersoner.
Dette lead-in design med tilhørende tumorbiopsier og perifere blodanalyser vil muliggøre mekanistiske analyser af effekten af LAG3 og PD1 blokade alene og i kombination for at øge forståelsen af mekanismer for respons og resistens.
Varighed af respons, progressionsfri overlevelse og sikkerhed vil blive vurderet som sekundære mål.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
43
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Hillman Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
• Mænd eller kvinder, der er 18 år eller ældre, der opfylder AJCC 8. udgaves kriterier for ikke-operabelt stadium IIIB, stadium IIIC, stadium IIID eller stadium IV melanom, som ikke har modtaget behandling med immunterapi i metastaserende omgivelser
Ekskluderingskriterier:
Kendte eller mistænkte CNS-metastaser, med følgende undtagelser:
- Forsøgspersoner med kontrollerede hjernemetastaser vil få lov til at tilmelde sig. Kontrollerede hjernemetastaser er defineret som ingen radiografisk progression i mindst 4 uger efter stråling og/eller kirurgisk behandling på tidspunktet for samtykke. Forsøgspersoner skal holde sig fra steroider i mindst 2 uger før randomisering.
- Personer med tegn eller symptomer på hjernemetastaser er ikke kvalificerede, medmindre hjernemetastaser udelukkes ved computertomografi eller magnetisk resonansbilleddannelse.
- Aktiv autoimmun sygdom, der kræver behandling, med undtagelse af type 1-diabetes mellitus, vitiligo, løst astma/atopi hos børn, kontrolleret hyper/hypothyroidisme, hypoadrenalisme eller hypopituitarisme.
- Forudgående systemisk behandling i metastaserende omgivelser, herunder anti-PD1, anti-PDL1, anti-PDL2, anti-CTLA-4 antistof eller ethvert andet antistof eller lægemiddel, der specifikt er målrettet mod T-celle costimulering eller immun checkpoint pathways; eller kemoterapi.
- Forudgående adjuverende behandling med anti-PD1, anti-PDL1 og/eller anti-LAG3 antistof. Bemærk, at forudgående adjuverende behandling med målrettet terapi (f.eks. BRAF/MEK-hæmning), anti-CTLA4 eller behandling, der ikke på anden måde er specificeret ovenfor, ville være tilladt.
- Okulært melanom
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Relatlimab
Cyklus 1: Relatlimab (BMS-986016) leveres som en steril 10 mg/ml formulering, der skal administreres som en intravenøs (IV) infusion med 160 mg IV i de første 4 uger (cyklus 1). Cyklus 2+: Kombinationsterapi vil blive administreret ved sekventiel infusion. Nivolumab administreret ved 480 mg IV efterfulgt af infusion af relatlimab ved 160 mg IV én gang hver 4. uge. |
Relatlimab (BMS-986016) - 10 mg/ml formulering, der skal administreres som en intravenøs (IV) infusion med 160 mg IV.
Andre navne:
|
|
Eksperimentel: Nivolumab
Cyklus 1: Nivolumab (BMS-936558) leveres som en steril 10 mg/ml formulering, der skal administreres som en IV-infusion ved 480 mg IV i de første 4 uger. Cyklus 2+: Kombinationsterapi vil blive administreret ved sekventiel infusion. Nivolumab administreret ved 480 mg IV efterfulgt af infusion af relatlimab ved 160 mg IV én gang hver 4. uge. |
Nivolumab (BMS-936558) - 10 mg/ml formulering, der skal administreres som en IV-infusion ved 480 mg IV.
Andre navne:
|
|
Eksperimentel: Relatlimab + Nivolumab
Cyklus 1+: Kombinationsterapi vil blive administreret ved sekventiel infusion.
Nivolumab administreret ved 480 mg IV efterfulgt af infusion af relatlimab ved 160 mg IV i de første 4 uger (cyklus 1), derefter en gang hver 4. uge derefter.
|
Kombinationsbehandling (Relatlimab + Nivolumab) vil blive administreret ved sekventiel infusion.
Nivolumab administreret ved 480 mg IV efterfulgt af infusion af relatlimab ved 160 mg IV.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
LAG3 Gene Expression From scRNAseq
Tidsramme: At Baseline
|
Percent Lymphocyte-activation gene 3 (LAG3) level (cell surface molecule expressed on activated T cells) expression from scRNAseq
|
At Baseline
|
|
LAG3 Gene Expression From scRNAseq
Tidsramme: At Week 4
|
Percent Lymphocyte-activation gene 3 (LAG3) level (cell surface molecule expressed on activated T cells) expression from scRNAseq
|
At Week 4
|
|
PD1 Expression
Tidsramme: At baseline (Week 0)
|
Percent PD1 (programmed cell death protein 1) expression after completion of lead-in phase.
|
At baseline (Week 0)
|
|
PD1 Expression
Tidsramme: At Week 4
|
Percent PD1 (programmed cell death protein 1) expression after completion of lead-in phase.
|
At Week 4
|
|
Change in Tumor Size
Tidsramme: At baseline and at 4 weeks
|
Percentage change in tumor size assessed per Response Evaluation Criteria in Solid Tumors. Per RECIST 1.1, Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
|
At baseline and at 4 weeks
|
|
Overall Response Rate (ORR)
Tidsramme: Beginning at 12 weeks post initial treatment, up to 4 years
|
Percent of participants experiencing Complete Response (CR) + Number of participants experiencing Partial Response (PR)/total patients assessed.
Per RECIST v1.1, CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
(Note: the appearance of one or more new lesions is also considered progression).
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
Beginning at 12 weeks post initial treatment, up to 4 years
|
|
Overall Response Rate (ORR) - ITT (Intent-to-treat) Population
Tidsramme: Beginning at 12 weeks post initial treatment, up to 4 years
|
Percent of participants experiencing Complete Response (CR) + Number of participants experiencing Partial Response (PR)/total patients assessed.
Per RECIST v1.1, CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
(Note: the appearance of one or more new lesions is also considered progression).
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
Beginning at 12 weeks post initial treatment, up to 4 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Varighed af svar
Tidsramme: 12 uger efter indledende behandling, op til 4 år
|
Tid fra første dokumenteret fuldstændig respons (CR) eller delvis respons (PR) indtil den første dato, hvor progressiv sygdom er objektivt dokumenteret.
Per RECIST v1.1, CR: Forsvinden af alle mållæsioner.
Eventuelle patologiske lymfeknuder (hvad enten de er mål eller ikke-mål) skal have reduktion i kort akse til
|
12 uger efter indledende behandling, op til 4 år
|
|
Progressionsfri overlevelse (PFS)
Tidsramme: Op til 4 år
|
Progressionsfri overlevelse er defineret som tiden mellem datoen for randomisering og den første dato for dokumenteret progression eller død på grund af enhver årsag, alt efter hvad der indtræffer først.
I henhold til RECIST v1.1, progressiv sygdom (PD): Mindst en stigning på 20 % i summen af diametre af mållæsioner, idet der tages udgangspunkt i den mindste sum af undersøgelsen (dette inkluderer basissummen, hvis den er den mindste i undersøgelsen).
Ud over den relative stigning på 20 % skal summen også vise en absolut stigning på mindst 5 mm.
|
Op til 4 år
|
|
Samlet overlevelse (OS)
Tidsramme: Op til 4 år
|
Samlet overlevelse er defineret som tiden mellem datoen for randomisering og dødsdatoen på grund af en hvilken som helst årsag.
|
Op til 4 år
|
|
Secondary Outcome: Clinical Benefit Rate
Tidsramme: 12 weeks post initial treatment, up to 4 years
|
Percent of patients with Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) / total patients assessed per RECIST v1.1.
CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
12 weeks post initial treatment, up to 4 years
|
|
Clinical Benefit Rate - ITT (Intent-to-treat) Population
Tidsramme: 12 weeks post initial treatment, up to 4 years
|
Percent of patients with Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) / total patients assessed per RECIST v1.1.
CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
12 weeks post initial treatment, up to 4 years
|
|
Progression-free Survival (PFS) by Lead-in Arm
Tidsramme: Up to 4 years
|
Progression-free survival is defined as the time between the date of randomization and the first date of documented progression or death due to any cause, whichever occurs first.
Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
|
Up to 4 years
|
|
CD8+ Tumor Infiltrating Lymphocytes
Tidsramme: At Baseline
|
Number of CD8+ tumor infiltrating lymphocytes present.
|
At Baseline
|
|
CD8+ Tumor Infiltrating Lymphocytes
Tidsramme: At Week 4
|
Number of CD8+ tumor infiltrating lymphocytes present.
|
At Week 4
|
|
CD4+ Tumor Infiltrating Lymphocytes
Tidsramme: At Week 4
|
Number of CD4+ tumor infiltrating lymphocytes present.
|
At Week 4
|
|
CD4+ Tumor Infiltrating Lymphocytes
Tidsramme: At Baseline
|
Number of CD4+ tumor infiltrating lymphocytes present.
|
At Baseline
|
|
LAG3 Levels - PBMC
Tidsramme: At Baseline
|
To determine the amount of LAG3 expressed on activated T cells in the blood through single-cell RNA sequencing.
The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
|
At Baseline
|
|
LAG3 Levels - PBMC
Tidsramme: At Week 4
|
To determine the amount of LAG3 expressed on activated T cells in the blood through single-cell RNA sequencing.
The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
|
At Week 4
|
|
LAG3 Levels - TIL
Tidsramme: At Baseline
|
To determine the amount of LAG3 expressed on activated tumor infiltrating lymphocytes (TIL) through single-cell RNA sequencing.
The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
|
At Baseline
|
|
LAG3 Levels - PBMC
Tidsramme: At Week 16
|
To determine the amount of LAG3 expressed on activated T cells in the blood through single-cell RNA sequencing.
The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
|
At Week 16
|
|
LAG3 Levels - TIL
Tidsramme: At Week 4
|
To determine the amount of LAG3 expressed on activated tumor infiltrating lymphocytes (TIL) through single-cell RNA sequencing.
The LAG3 expression is reported as the natural log (ln) of the number of LAG3 transcripts divided by the number of total mapped reads plus 1.
|
At Week 4
|
|
PD-1 Expression in PBMC
Tidsramme: At Baseline
|
To determine the amount of PD-1 (programmed cell death protein 1) expressed on PBMCs through single-cell RNA sequencing in treated patients.
The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
|
At Baseline
|
|
PD-1 Expression in PBMC
Tidsramme: At Week 4
|
To determine the amount of PD-1 (programmed cell death protein 1) expressed on PBMCs through single-cell RNA sequencing in treated patients.
The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
|
At Week 4
|
|
PD-1 Expression in PBMC
Tidsramme: At Week 16
|
To determine the amount of PD-1 (programmed cell death protein 1) expressed on PBMCs through single-cell RNA sequencing in treated patients.
The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
|
At Week 16
|
|
PD-1 Expression in TIL
Tidsramme: At Baseline
|
To determine the amount of PD-1 (programmed cell death protein 1) expressed on TILs through single-cell RNA sequencing in treated patients.
The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
|
At Baseline
|
|
PD-1 Expression in TIL
Tidsramme: At Week 4
|
To determine the amount of PD-1 (programmed cell death protein 1) expressed on TILs through single-cell RNA sequencing in treated patients.
The PD-1 expression is reported as the natural log (ln) of the number of PD-1 transcripts divided by the number of total mapped reads plus 1.
|
At Week 4
|
|
Cell Effector/Memory Status - TIL
Tidsramme: At Baseline
|
Measure of cells that have previously encountered and responded to their cognate antigen in TIL.
|
At Baseline
|
|
Cell Effector/Memory Status - TIL
Tidsramme: At Week 4
|
Measure of cells that have previously encountered and responded to their cognate antigen in TIL.
|
At Week 4
|
|
Cell Effector/Memory Status - PBMCs
Tidsramme: At Baseline
|
Measure of cells that have previously encountered and responded to their cognate antigen in PBMCs.
|
At Baseline
|
|
Cell Effector/Memory Status - PBMC
Tidsramme: At Week 4
|
Measure of cells that have previously encountered and responded to their cognate antigen in PBMCs.
|
At Week 4
|
|
Cell Effector/Memory Status - PBMC
Tidsramme: At Week 16
|
Measure of cells that have previously encountered and responded to their cognate antigen in PBMCs.
|
At Week 16
|
|
Regulatory T Cell (Treg) Marker Levels - PMBCs
Tidsramme: At Baseline
|
Amount of Regulatory T cell (Treg) markers present in PBMCs in treated patients.
|
At Baseline
|
|
Regulatory T Cell (Treg) Marker Levels - PMBCs
Tidsramme: At Week 4
|
Amount of Regulatory T cell (Treg) markers present in PBMCs in treated patients.
|
At Week 4
|
|
Regulatory T Cell (Treg) Marker Levels - PMBCs
Tidsramme: At Week 16
|
Amount of Regulatory T cell (Treg) markers present in PBMCs in treated patients.
|
At Week 16
|
|
Regulatory T Cell (Treg) Marker Levels - TIL
Tidsramme: At Baseline
|
Amount of Regulatory T cell (Treg) markers present in TILs in treated patients.
|
At Baseline
|
|
Regulatory T Cell (Treg) Marker Levels - TIL
Tidsramme: At Week 4
|
Amount of Regulatory T cell (Treg) markers present in TILs in treated patients.
|
At Week 4
|
|
Activation and Maturation of Dendritic Cells - PBMC
Tidsramme: At Baseline
|
Measure of expression of activation and maturation of dendritic cells in PBMCs.
|
At Baseline
|
|
Activation and Maturation of Dendritic Cells - PBMC
Tidsramme: At Week 4
|
Measure of expression of activation and maturation of dendritic cells in PBMCs.
|
At Week 4
|
|
Activation and Maturation of Dendritic Cells - PBMC
Tidsramme: At Week 16
|
Measure of expression of activation and maturation of dendritic cells in PBMCs.
|
At Week 16
|
|
Activation and Maturation of Dendritic Cells - TIL
Tidsramme: At Baseline
|
Measure of expression of activation and maturation of dendritic cells in tumor (TIL).
|
At Baseline
|
|
Activation and Maturation of Dendritic Cells - TIL
Tidsramme: At Week 4
|
Measure of expression of activation and maturation of dendritic cells in tumor (TIL).
|
At Week 4
|
|
Soluble LAG3 Levels - PBMC
Tidsramme: At the time of disease progression - up to 4 years
|
Amount of LAG3 (cell surface molecule expressed on activated T cells) protein present in blood in patients that had previously demonstrated complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
At the time of disease progression - up to 4 years
|
|
Soluble LAG3 Levels - TIL
Tidsramme: At the time of disease progression - up to 4 years
|
Amount of LAG3 (cell surface molecule expressed on activated T cells) protein present in tumor tissue in patients that had previously demonstrated complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
At the time of disease progression - up to 4 years
|
|
Granzyme B Serum Levels
Tidsramme: At 2 weeks prior first study treatment, at 4 weeks, at 12 weeks
|
Level of granzyme B (a serine protease secreted cells to mediate apoptosis in target cells) in serum.
|
At 2 weeks prior first study treatment, at 4 weeks, at 12 weeks
|
|
T Cell Count
Tidsramme: At 4 weeks
|
Number of T cells present in TIL or PBMC.
|
At 4 weeks
|
|
T Cell Count
Tidsramme: At 12 weeks
|
Number of T cells present in TIL or PBMC.
|
At 12 weeks
|
|
T Cell Count
Tidsramme: At the time of disease progression - up to 4 years
|
Number of T cells present in TIL or PBMC.
|
At the time of disease progression - up to 4 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Single Cell RNA Sequencing
Tidsramme: 2 weeks
|
The presence and quantity of RNA in in blood and tumor tissue.
|
2 weeks
|
|
Single Cell RNA Sequencing
Tidsramme: At 4 weeks post Cycle 1
|
The presence and quantity of RNA in in blood and tumor tissue.
|
At 4 weeks post Cycle 1
|
|
Single Cell RNA Sequencing
Tidsramme: At week 16 (12 weeks post combination treatment (3 cycles)
|
The presence and quantity of RNA in in blood and tumor tissue.
|
At week 16 (12 weeks post combination treatment (3 cycles)
|
|
Single Cell RNA Sequencing
Tidsramme: At the time of disease progression - up to 4 years
|
The presence and quantity of RNA in in blood and tumor tissue in patients that had previously demonstrated complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
CR: Disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
|
At the time of disease progression - up to 4 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John Kirkwood, MD, University of Pittsburgh
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
29. marts 2019
Primær færdiggørelse (Faktiske)
3. juli 2024
Studieafslutning (Faktiske)
3. juli 2025
Datoer for studieregistrering
Først indsendt
18. oktober 2018
Først indsendt, der opfyldte QC-kriterier
15. november 2018
Først opslået (Faktiske)
16. november 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2026
Sidst verificeret
1. december 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Hudsygdomme
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Neoplasmer i huden
- Hud- og bindevævssygdomme
- Melanom
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Nivolumab
- Relatlimab
Andre undersøgelses-id-numre
- 18-071
Plan for individuelle deltagerdata (IPD)
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