Et fase 3-studie til evaluering af petosemtamab sammenlignet med investigator's Choice monoterapi hos tidligere behandlede hoved- og nakkepladecellekræftpatienter
En fase 3 åben-label, randomiseret kontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af petosemtamab sammenlignet med investigator's Choice monoterapibehandling hos tidligere behandlede patienter med uhelbredeligt, metastatisk/tilbagevendent hoved- og nakkepladecellecarcinom
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
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
-
-
-
-
-
Montreal, Canada, H2X 0A9
- Site 172
-
Toronto, Canada, M4N 3M5
- Site 196
-
-
-
-
-
Providencia, Chile, 7500859
- Site 16
-
Recoleta, Chile, 8420000
- Site 20
-
Santiago, Chile, 7500921
- Site 27
-
Santiago, Chile, 7560908
- Site 21
-
-
-
-
-
Cambridge, Det Forenede Kongerige, CB2 0QQ
- Site 65
-
Cardiff, Det Forenede Kongerige, CF14 2TL
- Site 174
-
Glasgow, Det Forenede Kongerige, G12 0YN
- Site 171
-
Liverpool, Det Forenede Kongerige, L7 8YA
- Site 44
-
London, Det Forenede Kongerige, E20 1JQ
- Site 157
-
London, Det Forenede Kongerige, EC1A 7BE
- Site 140
-
London, Det Forenede Kongerige, SE1 9RT
- Site 90
-
London, Det Forenede Kongerige, SW3 6JJ
- Site 42
-
Manchester, Det Forenede Kongerige, M20 4BX
- Site 48
-
Middlesex, Det Forenede Kongerige, HA6 2RN
- Site 70
-
Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Site 191
-
Sutton, Det Forenede Kongerige, SM2 5PT
- Site 43
-
-
-
-
Alabama
-
Mobile, Alabama, Forenede Stater, 36608
- Site 160
-
-
Arizona
-
Prescott, Arizona, Forenede Stater, 86301
- Site 102
-
Scottsdale, Arizona, Forenede Stater, 85054
- Site 125
-
-
California
-
Duarte, California, Forenede Stater, 91010
- Site 82
-
La Jolla, California, Forenede Stater, 92037
- Site 25
-
Orange, California, Forenede Stater, 92868
- Site 173
-
Palo Alto, California, Forenede Stater, 94304
- Site 28
-
Sacramento, California, Forenede Stater, 95817
- Site 127
-
San Francisco, California, Forenede Stater, 94158
- Site 46
-
-
Colorado
-
Lone Tree, Colorado, Forenede Stater, 80124
- Site 130
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20010
- Site 104
-
-
Florida
-
Fort Myers, Florida, Forenede Stater, 33901
- Site 12
-
Jacksonville, Florida, Forenede Stater, 32224
- Site 123
-
Orlando, Florida, Forenede Stater, 32827
- Site 9
-
Tampa, Florida, Forenede Stater, 33612
- Site 138
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Site 187
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60607
- Site 152
-
Chicago, Illinois, Forenede Stater, 60611
- Site 213
-
Chicago, Illinois, Forenede Stater, 60637
- Site 68
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Site 31
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40202
- Site 8
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Site 40
-
New Orleans, Louisiana, Forenede Stater, 70121
- Site 100
-
-
Maryland
-
Columbia, Maryland, Forenede Stater, 21044
- Site 153
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Site 77
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- Site 103
-
Detroit, Michigan, Forenede Stater, 48201
- Site 5
-
-
Minnesota
-
Maple Grove, Minnesota, Forenede Stater, 55369
- Site 49
-
Rochester, Minnesota, Forenede Stater, 55905
- Site 124
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63110
- Site 18
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- Site 86
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87131
- Site 15
-
-
New York
-
New York, New York, Forenede Stater, 10029
- Site 24
-
The Bronx, New York, Forenede Stater, 10461
- Site 214
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- Site 98
-
Durham, North Carolina, Forenede Stater, 27710
- Site 122
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- Site 23
-
Cleveland, Ohio, Forenede Stater, 44106
- Site 218
-
Cleveland, Ohio, Forenede Stater, 44195
- Site 87
-
Columbus, Ohio, Forenede Stater, 43210
- Site 32
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97213
- Site 26
-
-
Pennsylvania
-
Bensalem, Pennsylvania, Forenede Stater, 19020
- Site 151
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Site 158
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Site 50
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Site 60
-
Memphis, Tennessee, Forenede Stater, 38103
- Site 54
-
Nashville, Tennessee, Forenede Stater, 37203
- Site 59
-
Nashville, Tennessee, Forenede Stater, 37232
- Site 67
-
-
Texas
-
Denison, Texas, Forenede Stater, 75020
- Site 55
-
El Paso, Texas, Forenede Stater, 79915
- Site 34
-
Houston, Texas, Forenede Stater, 77030
- Site 51
-
Houston, Texas, Forenede Stater, 77030
- Site 7
-
Pearland, Texas, Forenede Stater, 77584
- Site 94
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Site 4
-
-
Virginia
-
Blacksburg, Virginia, Forenede Stater, 24060
- Site 10
-
Charlottesville, Virginia, Forenede Stater, 22908
- Site 22
-
Winchester, Virginia, Forenede Stater, 22601
- Site 156
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Site 163
-
Spokane, Washington, Forenede Stater, 99202
- Site 6
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53705
- Site 216
-
-
-
-
-
Bordeaux, Frankrig, 33075
- Site 105
-
Brest, Frankrig, 29200
- Site 211
-
Le Mans, Frankrig, 72000
- Site 162
-
Lille, Frankrig, 59000
- Site 149
-
Lyon, Frankrig, 69373
- Site 118
-
Marseille, Frankrig, 13005
- Site 115
-
Montpellier, Frankrig, 34298
- Site 106
-
Nice, Frankrig, 06189
- Site 169
-
Paris, Frankrig, 75005
- Site 114
-
Paris, Frankrig, 75013
- Site 167
-
Poitiers, Frankrig, 86000
- Site 136
-
Rennes, Frankrig, 35042
- Site 141
-
Rouen, Frankrig, 76038
- Site 107
-
Toulouse, Frankrig, 31059
- Site 119
-
Vandœuvre-lès-Nancy, Frankrig, 54519
- Site 142
-
Villejuif, Frankrig, 94800
- Site 113
-
-
-
-
-
Athens, Grækenland, 124 62
- Site 91
-
Heraklion, Grækenland, 71500
- Site 120
-
Thessaloniki, Grækenland, 55236
- Site 83
-
-
-
-
-
Amsterdam, Holland, 1066 CX
- Site 76
-
Nijmegen, Holland, 6525 GA
- Site 61
-
Utrecht, Holland, 3584 CX
- Site 66
-
-
-
-
-
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
-
-
-
-
-
Kaunas, Litauen, 50161
- Site 180
-
Vilnius, Litauen, 08406
- Site 181
-
-
-
-
-
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
-
-
-
-
-
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, Tjekkiet, 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, Ungarn, 4400
- Site 204
-
Pécs, Ungarn, 7624
- Site 195
-
Szeged, Ungarn, 6725
- Site 198
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
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 |
|---|---|
|
Aktiv komparator: Efterforskerens valg
|
Cetuximab Methotrexate Docetaxel |
|
Eksperimentel: MCLA-158
|
MCLA-158 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 3 years
|
OS was defined as the time from randomization to death due to any cause. |
Up to approximately 3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to first 6 cycles
|
Clearance of plasma and central volume of distribution based on population PK model |
Up to first 6 cycles
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Study Official, Genmab
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .