Delstudie 02C: Sikkerhed og effekt af Pembrolizumab i kombination med undersøgelsesmidler eller Pembrolizumab alene hos deltagere med trin III melanom, som er kandidater til neoadjuverende terapi (MK-3475-02C/KEYMAKER-U02)
5. august 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 1/2 Open-Label Rolling Arm Paraply Platform-design af undersøgelsesagenter med eller uden Pembrolizumab eller Pembrolizumab alene hos deltagere med melanom (KEYMAKER-U02): Delstudie 02C
Delstudie 02C er en del af et større forskningsstudie, der tester eksperimentelle behandlinger for melanom, en type hudkræft. Det større studie er paraplystudiet.
Målet med delstudie 02C er at evaluere sikkerheden og effektiviteten af undersøgelsesbehandlingsarme hos deltagere med trin III melanom, som er kandidater til neoadjuverende terapi for at identificere det eller de forsøgsmidler, der, når de anvendes i kombination, er overlegne i forhold til de nuværende behandlingsmuligheder /historisk kontrol tilgængelig.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
146
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Wollstonecraft, New South Wales, Australien, 2065
- Melanoma Institute Australia ( Site 3402)
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Queensland
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Southport, Queensland, Australien, 4215
- Tasman Oncology Research Pty Ltd ( Site 3403)
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Western Australia
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Murdoch, Western Australia, Australien, 6150
- Fiona Stanley Hospital ( Site 3401)
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California
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Los Angeles, California, Forenede Stater, 90025
- The Angeles Clinic and Research Institute ( Site 3009)
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Santa Monica, California, Forenede Stater, 90404
- Providence Saint John's Health Center ( Site 3010)
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado, Anschutz Cancer Pavilion ( Site 3012)
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)
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New York
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New York, New York, Forenede Stater, 10016
- NYU Clinical Cancer Center ( Site 3002)
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke Cancer Institute ( Site 3005)
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Ohio
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Columbus, Ohio, Forenede Stater, 43221
- Martha Morehouse Tower ( Site 3020)
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Science University ( Site 3013)
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Abramson Cancer Center ( Site 3008)
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- West Cancer Center - East Campus ( Site 3014)
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Inova Schar Cancer Institute ( Site 3011)
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Paris, Frankrig, 75010
- A.P.H. Paris, Hopital Saint Louis ( Site 3107)
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Frankrig, 13005
- Hopital La Timone ( Site 3103)
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrig, 31059
- Institut Claudius Regaud ( Site 3105)
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Rhone
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Pierre-Bénite, Rhone, Frankrig, 69495
- Centre Hospitalier Lyon Sud ( Site 3102)
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Île-de-France Region
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Villejuif, Île-de-France Region, Frankrig, 94805
- Gustave Roussy ( Site 3101)
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Afula, Israel, 1834111
- HaEmek Medical Center ( Site 3703)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology ( Site 3704)
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Jerusalem, Israel, 9112001
- Hadassah Ein Karem Jerusalem ( Site 3702)
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Petah Tikva, Israel, 4941492
- Rabin Medical Center-Oncology ( Site 3705)
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Ramat Gan, Israel, 5265601
- Chaim Sheba Medical Center ( Site 3701)
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Milan, Italien, 20141
- Istituto Europeo di Oncologia ( Site 3301)
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Siena, Italien, 53100
- Policlinico Le Scotte - A.O. Senese ( Site 3377)
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Canton of Geneva
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Geneva, Canton of Geneva, Schweiz, 1211
- Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 3603)
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Canton of Vaud
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Lausanne, Canton of Vaud, Schweiz, 1011
- CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)
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Canton of Zurich
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Zuerich Flughafen, Canton of Zurich, Schweiz, 8058
- Universitaetsspital Zuerich ( Site 3601)
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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 til 120 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Har histologisk eller cytologisk bekræftet melanom
- Har klinisk påviselig og resekterbar trin IIIB eller IIIC eller IIID melanom, der er modtagelig for kirurgi
Har været ubehandlet for trin IIIB, IIIC eller IIID melanom
- kirurgisk resektion af primært melanom er tilladt
- forudgående strålebehandling af det primære melanom er tilladt
- Har givet en baseline tumorbiopsi
- Mandlige deltagere, der modtager gebasaxturev, afholder sig fra heteroseksuelt samleje eller accepterer at bruge prævention i interventionsperioden og i mindst 120 dage efter den sidste dosis af gebasaxturev
- Mandlige deltagere, der modtager ATRA, afholder sig fra heteroseksuelt samleje eller accepterer at bruge prævention i interventionsperioden og i mindst 7 dage efter den sidste dosis ATRA
- Kvindelige deltagere er ikke gravide eller ammer og er enten ikke en kvinde i den fødedygtige alder (WOCBP) ELLER bruger en præventionsmetode, der er yderst effektiv eller afholder sig fra heteroseksuelt samleje i interventionsperioden og i mindst 120 dage efter sidste dosis pembrolizumab, vibostolimab, gebasaxturev eller MK-4830, favezelimab + pembrolizumab eller 30 dage efter den sidste dosis ATRA, alt efter hvad der indtræffer sidst
- Har tilstrækkelig organfunktion
- Har opløsning af toksiske virkning(er) af den seneste tidligere behandling til grad 1 eller mindre (undtagen alopeci)
Ekskluderingskriterier:
- Har en diagnose af immundefekt eller modtager immunsuppressiv behandling inden for 7 dage før den første dosis af undersøgelsesintervention
- Har en kendt yderligere malignitet, der skrider frem eller kræver aktiv behandling inden for de seneste 2 år
- Har kendte metastaser i centralnervesystemet (CNS) og/eller karcinomatøs meningitis
- Har okulært eller slimhinde melanom
- Har kendt overfølsomhed, herunder tidligere klinisk signifikant overfølsomhedsreaktion på behandling med et andet monoklonalt antistof (mAb)
- Har en aktiv autoimmun sygdom, der har krævet systemisk behandling i de seneste 2 år
- Har en aktiv infektion, der kræver systemisk terapi
- Har kendt historie med human immundefektvirus (HIV)
- Har kendt historie med hepatitis B
- Har en historie med (ikke-infektiøs) pneumonitis
- Har en historie med aktiv tuberkulose (TB)
- Har tidligere modtaget systemisk anticancerbehandling inden for 4 uger før randomisering
- Har modtaget tidligere strålebehandling inden for 2 uger efter første dosis af undersøgelsesintervention
- Har haft en større operation <3 uger før første dosis af undersøgelsesintervention
- Har modtaget en levende eller levende svækket vaccine inden for 30 dage før den første dosis af undersøgelsesintervention
- Har deltaget i en undersøgelse af et forsøgsmiddel inden for 4 uger før den første dosis af undersøgelsesintervention
- Har fået transplanteret allogen væv/fast organ
- Har kun slimhindelæsioner
- Er ikke naiv over for Talimogene laherparepvec (TVEC) og andre onkolytiske vira
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 |
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Eksperimentel: Pembrolizumab + Vibostolimab
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
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Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
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Eksperimentel: Pembrolizumab + Gebasaxturev
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
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Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
Indgives via IT-injektion i en specificeret dosis på bestemte dage
Andre navne:
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Eksperimentel: Pembrolizumab
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
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Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
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Eksperimentel: Pembrolizumab + MK-4830
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
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Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
Administreret via IV infusion i en specificeret dosis på bestemte dage
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Eksperimentel: Favezelimab (+) Pembrolizumab
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
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Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
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Eksperimentel: Pembrolizumab + All-Trans Retinoic Acid (ATRA)
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
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Administreret via IV infusion i en specificeret dosis på bestemte dage
Andre navne:
Indgivet via orale kapsler i en specificeret dosis på bestemte dage
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Who Experienced an Adverse Event (AE)
Tidsramme: Up to approximately 17 months
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The percentage of participants who experienced an AE was reported.
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Up to approximately 17 months
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Percentage of Participants Who Discontinued Study Intervention Due to an AE
Tidsramme: Up to approximately 13 months
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The percentage of participants who discontinued study intervention due to an AE was reported.
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Up to approximately 13 months
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Pathological Complete Response (pCR) Rate With 90% Confidence Interval (CI)
Tidsramme: Up to approximately 6 weeks
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pCR rate was defined as the percentage of participants with complete absence of viable tumor in the treated tumor bed as assessed by central review of the pathology results.
Per protocol, pCR rate with 90% CI was reported.
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Up to approximately 6 weeks
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pCR Rate With 95% CI
Tidsramme: Up to approximately 6 weeks
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pCR rate was defined as the percentage of participants with complete absence of viable tumor in the treated tumor bed as assessed by central review of the pathology results.
Per protocol, pCR rate with 95% CI was reported.
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Up to approximately 6 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Near pCR Rate With 90% CI
Tidsramme: Up to approximately 6 weeks
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Near pCR was defined as the percentage of participants with >0% but ≤10% of viable tumor cells in the treated tumor bed as assessed by central review of the pathology results.
Per protocol, near pCR rate with 90% CI was reported.
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Up to approximately 6 weeks
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Near pCR Rate With 95% CI
Tidsramme: Up to approximately 6 weeks
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Near pCR was defined as the percentage of participants with >0% but ≤10% of viable tumor cells in the treated tumor bed as assessed by central review of the pathology results.
Per protocol, near pCR rate with 95% CI was reported.
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Up to approximately 6 weeks
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Pathological Partial Response (pPR) Rate With 90% CI
Tidsramme: Up to approximately 6 weeks
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pPR rate was defined as the percentage of participants with >10% but ≤50% of the treated tumor bed occupied by viable tumor cells as assessed by central review of the pathology results.
Per protocol, pPR rate with 90% CI was reported.
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Up to approximately 6 weeks
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pPR Rate With 95% CI
Tidsramme: Up to approximately 6 weeks
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pPR rate was defined as the percentage of participants with >10% but ≤50% of the treated tumor bed occupied by viable tumor cells as assessed by central review of the pathology results.
Per protocol, pPR rate with 95% CI was reported.
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Up to approximately 6 weeks
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Recurrence-Free Survival (RFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by The Investigator
Tidsramme: Up to approximately 62 months
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RFS was defined as the time from the date of surgery to (1) any recurrence (local, regional, or distant) per RECIST 1.1 as assessed by the investigator or (2) death due to any cause (both cancer and noncancer causes of death).
Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ).
Per protocol, RFS per RECIST 1.1 as assessed by the investigator was presented.
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Up to approximately 62 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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)
26. juni 2020
Primær færdiggørelse (Faktiske)
24. september 2025
Studieafslutning (Faktiske)
24. september 2025
Datoer for studieregistrering
Først indsendt
9. marts 2020
Først indsendt, der opfyldte QC-kriterier
9. marts 2020
Først opslået (Faktiske)
10. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2026
Sidst verificeret
1. august 2026
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
- Parkinson Disease 4, Autosomal Dominant Lewy Body
- Organiske kemikalier
- Retinoider
- Carotenoider
- Polyener
- Alkener
- Kulbrinter, acyklisk
- Kulbrinter
- Cyclohexener
- Cyclohexanes
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Pigmenter, biologisk
- Biologiske faktorer
- Diterpenes
- A -vitamin
- Tretinoin
- pembrolizumab
Andre undersøgelses-id-numre
- 3475-02C
- 2019 (U.S. NIH-bevilling/kontrakt: Chief Medical Office (CMO) Alberta Health Services)
- 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
- KEYMAKER-U02 (Anden identifikator: MSD)
- MK-3475-02C (Anden identifikator: MSD)
- 2019-003978-22 (EudraCT nummer)
- 2023-506314-51-00 (Registry Identifier: EU CT)
- U1111-1293-5665 (Registry Identifier: UTN)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .