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En fas 3-studie för att utvärdera petosemtamab jämfört med utredarens val monoterapi hos tidigare behandlade patienter med skivepitelcancer i huvud och hals

29 oktober 2026 uppdaterad av: Genmab

En öppen fas 3, randomiserad kontrollerad studie för att utvärdera effekten och säkerheten av petosemtamab jämfört med utredarens val monoterapibehandling hos tidigare behandlade patienter med obotligt, metastaserande/återkommande skivepitelcancer i huvud och hals

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.

Studieöversikt

Detaljerad beskrivning

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

Studietyp

Interventionell

Inskrivning (Faktisk)

621

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Caba, Argentina, C1280AEB
        • Site 58
      • Córdoba, Argentina, X5008HHW
        • Site 45
      • Rosario, Argentina, S2000KZE
        • Site 110
      • Viedma, Argentina, 8500
        • Site 57
      • Darlinghurst, Australien, 2010
        • Site 3
      • Herston, Australien, 4060
        • Site 170
      • Melbourne, Australien, 3000
        • Site 38
      • Nedlands, Australien, 6009
        • Site 30
      • Saint Leonards, Australien, 2065
        • Site 11
      • Sydney, Australien, 2050
        • Site 73
      • Brussels, Belgien, 1200
        • Site 56
      • Ghent, Belgien, 9000
        • Site 92
      • Leuven, Belgien, 3000
        • Site 72
      • Liège, Belgien, 4000
        • Site 108
      • Namur, Belgien, 5000
        • Site 69
      • Brasília, Brasilien, 70390-140
        • Site 154
      • Porto Alegre, Brasilien, 90110-270
        • Site 145
      • Porto Alegre, Brasilien, 90610-000
        • Site 150
      • Recife, Brasilien, 50040-000
        • Site 146
      • Rio de Janeiro, Brasilien, 22281-100
        • Site 148
      • São Paulo, Brasilien, 01509-900
        • Site 147
      • São Paulo, Brasilien, 04538-132
        • Site 144
      • Providencia, Chile, 7500859
        • Site 16
      • Recoleta, Chile, 8420000
        • Site 20
      • Santiago, Chile, 7500921
        • Site 27
      • Santiago, Chile, 7560908
        • Site 21
      • Bordeaux, Frankrike, 33075
        • Site 105
      • Brest, Frankrike, 29200
        • Site 211
      • Le Mans, Frankrike, 72000
        • Site 162
      • Lille, Frankrike, 59000
        • Site 149
      • Lyon, Frankrike, 69373
        • Site 118
      • Marseille, Frankrike, 13005
        • Site 115
      • Montpellier, Frankrike, 34298
        • Site 106
      • Nice, Frankrike, 06189
        • Site 169
      • Paris, Frankrike, 75005
        • Site 114
      • Paris, Frankrike, 75013
        • Site 167
      • Poitiers, Frankrike, 86000
        • Site 136
      • Rennes, Frankrike, 35042
        • Site 141
      • Rouen, Frankrike, 76038
        • Site 107
      • Toulouse, Frankrike, 31059
        • Site 119
      • Vandœuvre-lès-Nancy, Frankrike, 54519
        • Site 142
      • Villejuif, Frankrike, 94800
        • Site 113
    • Alabama
      • Mobile, Alabama, Förenta staterna, 36608
        • Site 160
    • Arizona
      • Prescott, Arizona, Förenta staterna, 86301
        • Site 102
      • Scottsdale, Arizona, Förenta staterna, 85054
        • Site 125
    • California
      • Duarte, California, Förenta staterna, 91010
        • Site 82
      • La Jolla, California, Förenta staterna, 92037
        • Site 25
      • Orange, California, Förenta staterna, 92868
        • Site 173
      • Palo Alto, California, Förenta staterna, 94304
        • Site 28
      • Sacramento, California, Förenta staterna, 95817
        • Site 127
      • San Francisco, California, Förenta staterna, 94158
        • Site 46
    • Colorado
      • Lone Tree, Colorado, Förenta staterna, 80124
        • Site 130
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20010
        • Site 104
    • Florida
      • Fort Myers, Florida, Förenta staterna, 33901
        • Site 12
      • Jacksonville, Florida, Förenta staterna, 32224
        • Site 123
      • Orlando, Florida, Förenta staterna, 32827
        • Site 9
      • Tampa, Florida, Förenta staterna, 33612
        • Site 138
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Site 187
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60607
        • Site 152
      • Chicago, Illinois, Förenta staterna, 60611
        • Site 213
      • Chicago, Illinois, Förenta staterna, 60637
        • Site 68
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Site 31
    • Kentucky
      • Louisville, Kentucky, Förenta staterna, 40202
        • Site 8
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70809
        • Site 40
      • New Orleans, Louisiana, Förenta staterna, 70121
        • Site 100
    • Maryland
      • Columbia, Maryland, Förenta staterna, 21044
        • Site 153
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Site 77
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • Site 103
      • Detroit, Michigan, Förenta staterna, 48201
        • Site 5
    • Minnesota
      • Maple Grove, Minnesota, Förenta staterna, 55369
        • Site 49
      • Rochester, Minnesota, Förenta staterna, 55905
        • Site 124
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Site 18
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Site 86
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87131
        • Site 15
    • New York
      • New York, New York, Förenta staterna, 10029
        • Site 24
      • The Bronx, New York, Förenta staterna, 10461
        • Site 214
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27514
        • Site 98
      • Durham, North Carolina, Förenta staterna, 27710
        • Site 122
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45219
        • Site 23
      • Cleveland, Ohio, Förenta staterna, 44106
        • Site 218
      • Cleveland, Ohio, Förenta staterna, 44195
        • Site 87
      • Columbus, Ohio, Förenta staterna, 43210
        • Site 32
    • Oregon
      • Portland, Oregon, Förenta staterna, 97213
        • Site 26
    • Pennsylvania
      • Bensalem, Pennsylvania, Förenta staterna, 19020
        • Site 151
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Site 158
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Site 50
    • Tennessee
      • Chattanooga, Tennessee, Förenta staterna, 37404
        • Site 60
      • Memphis, Tennessee, Förenta staterna, 38103
        • Site 54
      • Nashville, Tennessee, Förenta staterna, 37203
        • Site 59
      • Nashville, Tennessee, Förenta staterna, 37232
        • Site 67
    • Texas
      • Denison, Texas, Förenta staterna, 75020
        • Site 55
      • El Paso, Texas, Förenta staterna, 79915
        • Site 34
      • Houston, Texas, Förenta staterna, 77030
        • Site 51
      • Houston, Texas, Förenta staterna, 77030
        • Site 7
      • Pearland, Texas, Förenta staterna, 77584
        • Site 94
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • Site 4
    • Virginia
      • Blacksburg, Virginia, Förenta staterna, 24060
        • Site 10
      • Charlottesville, Virginia, Förenta staterna, 22908
        • Site 22
      • Winchester, Virginia, Förenta staterna, 22601
        • Site 156
    • Washington
      • Seattle, Washington, Förenta staterna, 98109
        • Site 163
      • Spokane, Washington, Förenta staterna, 99202
        • Site 6
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53705
        • Site 216
      • Athens, Grekland, 124 62
        • Site 91
      • Heraklion, Grekland, 71500
        • Site 120
      • Thessaloniki, Grekland, 55236
        • Site 83
      • Haifa, Israel, 3109601
        • Site 19
      • Jerusalem, Israel, 9112001
        • Site 1
      • Ramat Gan, Israel, 5265601
        • Site 14
      • Tel Aviv, Israel, 6423906
        • Site 2
      • Brescia, Italien, 25123
        • Site 93
      • Cuneo, Italien, 12100
        • Site 111
      • Milan, Italien, 20133
        • Site 128
      • Milan, Italien, 20141
        • Site 81
      • Naples, Italien, 80131
        • Site 209
      • Naples, Italien, 80131
        • Site 89
      • Roma, Italien, 00161
        • Site 203
      • Rozzano, Italien, 20089
        • Site 85
      • Chūōku, Japan, 104-0045
        • Site 132
      • Fukuoka, Japan, 812-8582
        • Site 192
      • Kashiwa, Japan, 277-8577
        • Site 131
      • Miki, Japan, 761-0793
        • Site 135
      • Nagoya, Japan, 464-8681
        • Site 139
      • Natori, Japan, 981-1293
        • Site 186
      • Sendai, Japan, 980-8574
        • Site 134
      • Ōsaka-sayama, Japan, 589-8511
        • Site 133
      • Montreal, Kanada, H2X 0A9
        • Site 172
      • Toronto, Kanada, M4N 3M5
        • Site 196
      • Kaunas, Litauen, 50161
        • Site 180
      • Vilnius, Litauen, 08406
        • Site 181
      • Amsterdam, Nederländerna, 1066 CX
        • Site 76
      • Nijmegen, Nederländerna, 6525 GA
        • Site 61
      • Utrecht, Nederländerna, 3584 CX
        • Site 66
      • Bydgoszcz, Polen, 85-796
        • Site 190
      • Gdansk, Polen, 80-214
        • Site 143
      • Gliwice, Polen, 44-102
        • Site 97
      • Krakow, Polen, 31-826
        • Site 177
      • Lodz, Polen, 93-513
        • Site 200
      • Poznan, Polen, 60-185
        • Site 117
      • Warsaw, Polen, 02-781
        • Site 179
      • Coimbra, Portugal, 3004-561
        • Site 182
      • Lisbon, Portugal, 1998-018
        • Site 183
      • Porto, Portugal, 4200-072
        • Site 185
      • Bellinzona, Schweiz, CH-6500
        • Site 184
      • Geneva, Schweiz, 1211
        • Site 189
      • Lausanne, Schweiz, 1011
        • Site 194
      • Sankt Gallen, Schweiz, 9007
        • Site 178
      • Barcelona, Spanien, 08035
        • Site 78
      • Madrid, Spanien, 28040
        • Site 109
      • Madrid, Spanien, 28040
        • Site 75
      • Madrid, Spanien, 28041
        • Site 71
      • Madrid, Spanien, 28050
        • Site 166
      • Pamplona, Spanien, 31008
        • Site 63
      • Pamplona, Spanien, 31008
        • Site 64
      • Valencia, Spanien, 46009
        • Site 74
      • Cambridge, Storbritannien, CB2 0QQ
        • Site 65
      • Cardiff, Storbritannien, CF14 2TL
        • Site 174
      • Glasgow, Storbritannien, G12 0YN
        • Site 171
      • Liverpool, Storbritannien, L7 8YA
        • Site 44
      • London, Storbritannien, E20 1JQ
        • Site 157
      • London, Storbritannien, EC1A 7BE
        • Site 140
      • London, Storbritannien, SE1 9RT
        • Site 90
      • London, Storbritannien, SW3 6JJ
        • Site 42
      • Manchester, Storbritannien, M20 4BX
        • Site 48
      • Middlesex, Storbritannien, HA6 2RN
        • Site 70
      • Newcastle upon Tyne, Storbritannien, NE7 7DN
        • Site 191
      • Sutton, Storbritannien, SM2 5PT
        • Site 43
      • Busan, Sydkorea, 48108
        • Site 161
      • Goyang-si, Sydkorea, 10408
        • Site 13
      • Hwasun, Sydkorea, 58128
        • Site 29
      • Seoul, Sydkorea, 03080
        • Site 137
      • Seoul, Sydkorea, 05505
        • Site 36
      • Seoul, Sydkorea, 06351
        • Site 47
      • Soeul, Sydkorea, 03722
        • Site 33
      • Suwon, Sydkorea, 16499
        • Site 164
      • Kaohsiung City, Taiwan, 807
        • Site 17
      • Kaohsiung City, Taiwan, 833
        • Site 95
      • Taichung, Taiwan, 40447
        • Site 53
      • Tainan, Taiwan, 70428
        • Site 176
      • Taipei, Taiwan, 112
        • Site 35
      • Taoyuan City, Taiwan, 333
        • Site 52
      • Olomouc, Tjeckien, 779 00
        • Site 201
      • Berlin, Tyskland, 12203
        • Site 121
      • Dresden, Tyskland, 01307
        • Site 210
      • Essen, Tyskland, 45147
        • Site 165
      • Giessen, Tyskland, 35390
        • Site 84
      • Greifswald, Tyskland, 17475
        • Site 62
      • Hanover, Tyskland, 30625
        • Site 112
      • Leipzig, Tyskland, 04103
        • Site 116
      • München, Tyskland, 81675
        • Site 168
      • Würzburg, Tyskland, 97080
        • Site 99
      • Nyíregyháza, Ungern, 4400
        • Site 204
      • Pécs, Ungern, 7624
        • Site 195
      • Szeged, Ungern, 6725
        • Site 198

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Signed ICF before initiation of any study procedures.
  • Age ≥ 18 years at signing of ICF.
  • Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
  • HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
  • The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
  • A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.
  • Measurable disease as defined by RECIST v1.1 by radiologic methods.
  • ECOG PS of 0 or 1
  • Life expectancy ≥ 12 weeks, as per investigator
  • Adequate organ function (as per protocol)

Exclusion Criteria:

  • Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
  • Known leptomeningeal involvement
  • Any systemic anticancer therapy within 4 weeks prior to randomization.
  • Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
  • Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
  • History of hypersensitivity reaction to any of the excipients of treatment required for this study.
  • Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
  • History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
  • Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
  • Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
  • Participants with known infectious diseases (as per protocol)
  • Pregnant or breastfeeding participants

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Utredarens val

Cetuximab

Methotrexate

Docetaxel

Experimentell: MCLA-158

MCLA-158

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: Up to approximately 3 years

OS was defined as the time from randomization to death due to any cause.

Up to approximately 3 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Tidsram: Up to approximately 2 years

ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.

Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review
Tidsram: Up to approximately 2 years

PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.

Up to approximately 2 years
Duration of Response (DOR) as Assessed by Blinded Independent Central Review
Tidsram: Up to approximately 2 years

For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.

Up to approximately 2 years
Objective Response Rate (ORR) as Assessed by Investigator Review
Tidsram: Up to approximately 2 years

ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.

Up to approximately 2 years
Progression Free Survival (PFS) as Assessed by Investigator Review
Tidsram: Up to approximately 2 years

PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.

Up to approximately 2 years
Duration of Response (DOR) as Assessed by Investigator Review
Tidsram: Up to approximately 2 years

For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of the first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.

Up to approximately 2 years
Time to Response (TTR) as Assessed by Blinded Independent Central Review
Tidsram: Up to approximately 2 years

For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.

Up to approximately 2 years
Time to Response (TTR) as Assessed by Investigator Review
Tidsram: Up to approximately 2 years

For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.

Up to approximately 2 years
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review
Tidsram: Up to approximately 2 years

CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1

Up to approximately 2 years
Clinical Benefit Rate (CBR) as Assessed by Investigator Review
Tidsram: Up to approximately 2 years

CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1

Up to approximately 2 years
Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE)
Tidsram: Up to 30 days post-last dose

An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one TEAE is presented.

Up to 30 days post-last dose
Number of Participants who Experienced At Least One Serious TEAE
Tidsram: Up to 30 days post-last dose

An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one serious TEAE is presented.

Up to 30 days post-last dose
Number of Participants who Discontinued Study Treatment Due to TEAEs
Tidsram: Up to 30 days post-last dose

An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who discontinued study treatment due to TEAEs is presented.

Up to 30 days post-last dose
Number of Participants who had Dose Modification Due to TEAEs
Tidsram: Up to 30 days post-last dose

An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who had dose modification due to TEAEs is presented.

Up to 30 days post-last dose
Pharmacokinetic parameters
Tidsram: Up to first 6 cycles

Clearance of plasma and central volume of distribution based on population PK model

Up to first 6 cycles

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Studierektor: Study Official, Genmab

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 juni 2024

Primärt slutförande (Beräknad)

1 februari 2028

Avslutad studie (Beräknad)

1 mars 2029

Studieregistreringsdatum

Först inskickad

3 juli 2024

Först inskickad som uppfyllde QC-kriterierna

3 juli 2024

Första postat (Faktisk)

11 juli 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • MCLA-158-CL02
  • 2023-510322-32-00 (Ctis)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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