Studie amivantamabu samotného nebo jako doplněk k jiným léčebným látkám u účastníků s recidivující/metastatickou rakovinou hlavy a krku (OrigAMI-4)
Fáze 1b/2, otevřená studie monoterapie amivantamabem a amivantamabem jako doplněk k standardním terapeutickým látkám u pacientů s recidivujícím/metastatickým spinocelulárním karcinomem hlavy a krku
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Study Contact
- Telefonní číslo: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studijní místa
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Avignon, Francie, 84918
- Nábor
- Institut Sainte Catherine
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Lille, Francie, 59000
- Nábor
- Centre Oscar Lambret
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Nantes, Francie, 44000
- Nábor
- CHU Nantes
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Paris, Francie, 75248
- Nábor
- Institut Curie
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Villejuif, Francie, 94805
- Nábor
- Gustave Roussy
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Nagoya, Japonsko, 464-8681
- Nábor
- Aichi Cancer Center
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Tokyo, Japonsko, 160-0023
- Nábor
- Tokyo Medical University Hospital
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Seoul, Jižní Korea, 05505
- Nábor
- Asan Medical Center
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Seoul, Jižní Korea, 03080
- Nábor
- Seoul National University Hospital
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Seoul, Jižní Korea, 06351
- Nábor
- Samsung Medical Center
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Seoul, Jižní Korea, 03722
- Nábor
- Severance Hospital Yonsei University Health System
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Kuala Lumpur, Malajsie, 59100
- Nábor
- University Malaya Medical Centre
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Kuala Lumpur, Malajsie, 59100
- Nábor
- Pantai Hospital Kuala Lumpur
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Essen, Německo, 45147
- Nábor
- Universitaetsklinikum Essen
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Leipzig, Německo, 04103
- Dokončeno
- Universitaetsklinikum Leipzig
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Stuttgart, Německo, 70174
- Nábor
- Klinikum der Landeshauptstadt Stuttgart
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Gdansk, Polsko, 80 214
- Nábor
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polsko, 44-102
- Nábor
- Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
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Warsaw, Polsko, 02 781
- Nábor
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Cambridge, Spojené království, CB2 0QQ
- Nábor
- Addenbrooke's Hospital
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Guildford, Spojené království, GU2 7XX
- Nábor
- The Royal Surrey County Hospital NHS Foundation Trust
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London, Spojené království, SW3 6JJ
- Nábor
- Royal Marsden Hospital
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London, Spojené království, W1T 7HA
- Nábor
- University College London Hospitals
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London, Spojené království, SM2 5PT
- Nábor
- Royal Marsden Hospital (Sutton)
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London, Spojené království, W12 0HS
- Dokončeno
- Imperial College London and Imperial College Healthcare NHS Trust
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Manchester, Spojené království, M20 4BX
- Nábor
- The Christie Nhs Foundation Trust
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California
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La Jolla, California, Spojené státy, 92093
- Dokončeno
- University of California at San Diego Moores Cancer Center
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Nábor
- University of Colorado Denver Anschultz Medical Campus
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520
- Nábor
- Yale Cancer Center
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Illinois
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Chicago, Illinois, Spojené státy, 60637
- Nábor
- The University of Chicago Medical Center (UCMC)
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Nábor
- University of Maryland School of Medicine
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Nábor
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- Nábor
- University of Michigan Rogel Cancer Center
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Detroit, Michigan, Spojené státy, 48201 2013
- Nábor
- Karmanos Cancer Institute
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Nábor
- Washington University School Of Medicine
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New Jersey
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New Brunswick, New Jersey, Spojené státy, 08901
- Nábor
- Rutgers Cancer Institute of New Jersey
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- Nábor
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Nábor
- Cleveland Clinic
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- Nábor
- University of Utah Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, Spojené státy, 22903
- Nábor
- University of Virginia
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Fairfax, Virginia, Spojené státy, 22031
- Nábor
- Virginia Cancer Specialists
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Changhua, Tchaj-wan, 500
- Nábor
- Changhua Christian Hospital
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Kaohsiung City, Tchaj-wan, 833
- Nábor
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Tchaj-wan, 100
- Nábor
- National Taiwan University Hospital
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Taipei, Tchaj-wan, 112
- Nábor
- Taipei Veterans General Hospital
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Taoyuan, Tchaj-wan, 33382
- Nábor
- Linkou Chang Gung Memorial Hospital
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Beijing, Čína, 100142
- Dokončeno
- Beijing Cancer Hospital of Peking University
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Cheng Du Shi, Čína, 610041
- Nábor
- West China School of Medicine/West China Hospital, Sichuan University
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Linyi, Čína, 276002
- Dokončeno
- Linyi Cancer Hospital
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Shanghai, Čína, 200120
- Nábor
- Shanghai East Hospital
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Shanghai, Čína, 200032
- Nábor
- Fudan Cancer Hospital
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Wuhan, Čína, 430022
- Nábor
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Barcelona, Španělsko, 08908
- Nábor
- Inst. Cat. Doncologia-H Duran I Reynals
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Barcelona, Španělsko, 08035
- Nábor
- Hosp Univ Vall D Hebron
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Madrid, Španělsko, 28034
- Nábor
- Hosp. Univ. Ramon Y Cajal
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Madrid, Španělsko, 28041
- Nábor
- Hosp. Univ. 12 de Octubre
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L/A) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease
- Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1.
- Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes [any grade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormone replacement)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test.
Participants should have: a) Hemoglobin >=9 grams per deciliter (g/dL); b) Neutrophils >=1.5 x 10^3/mcg; c) Platelets >=100 x 10^3/mcg
Exclusion Criteria:
- Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
- Participant with a history of clinically significant cardiovascular disease
- Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
- Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Cohort 1: Amivantamab Monotherapy (Dose Expansion)
Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight >=80 kilograms [kg]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight >=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards. |
Amivantamab will be administered subcutaneously.
Ostatní jména:
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Experimentální: Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight >=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight >=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous (IV) injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle). |
Amivantamab will be administered subcutaneously.
Ostatní jména:
Pembrolizumab will be administered intravenously.
Ostatní jména:
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Experimentální: Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight >=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight >=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg/m^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A. |
Amivantamab will be administered subcutaneously.
Ostatní jména:
Paclitaxel will be administered intravenously.
Ostatní jména:
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Experimentální: Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel
Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg/m^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A. |
Amivantamab will be administered subcutaneously.
Ostatní jména:
Paclitaxel will be administered intravenously.
Ostatní jména:
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Experimentální: Cohort 4: Amivantamab Monotherapy
Participants will receive subcutaneous injection of amivantamab monotherapy 1600 mg (2240 mg, if body weight >=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight >=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards. |
Amivantamab will be administered subcutaneously.
Ostatní jména:
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Experimentální: Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion)
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight >=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight >=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards in addition to intravenous injection of pembrolizumab 200 mg on Day 1 of each cycle, and carboplatin (area under the concentration-time curve [AUC] 5 milligram per milliliter [mg/ml]*min) q3w on Day 1 of Cycles 1-6. |
Amivantamab will be administered subcutaneously.
Ostatní jména:
Pembrolizumab will be administered intravenously.
Ostatní jména:
Carboplatin will be administered intravenously.
Ostatní jména:
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Experimentální: Cohort 6: Amivantamab + Pembrolizumab
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight >=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight >=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle) (Neoadjuvant Phase). In the adjuvant phase, pembrolizumab IV (200 mg) will be administered q3w from Adjuvant Cycle 1 Day 1 to Adjuvant Cycle 15 Day 1 and amivantamab SC 2,400 mg (3,360 mg for >80 kg) will be administered q3w from Adjuvant Cycle 4 Day 1 to Adjuvant Cycle 15 Day 1. |
Amivantamab will be administered subcutaneously.
Ostatní jména:
Pembrolizumab will be administered intravenously.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
Časové okno: 2 years and 2 months
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ORR is defined as the proportion of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1. |
2 years and 2 months
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Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)
Časové okno: Up to 21 days
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Number of participants with DLTs will be reported. A DLT is defined as any of the following: treatment delay of greater than (>) 28 days due to unresolved toxicity, non-hematologic toxicity of Grade 3 or higher, hematologic toxicity of Grade 4 neutropenia persisting for >7 days or Grade 3 or higher thrombocytopenia with clinically significant bleeding or neutropenic fever of any grade, and liver enzyme elevation. |
Up to 21 days
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Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
Časové okno: 2 years and 1 month
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event. |
2 years and 1 month
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Cohort 6: Major Pathologic Response (MPR)
Časové okno: 2 years and 2 months
|
The participants who achieve MPR at the time of surgery. |
2 years and 2 months
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR)
Časové okno: 2 years and 2 months
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DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR. |
2 years and 2 months
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Cohorts 1, 2, 3B, 4 and 5: Clinical Benefit Rate (CBR)
Časové okno: 2 years and 2 months
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CBR is defined as the percentage of participants achieving a confirmed complete or partial response, or durable stable disease (the second disease assessment) as defined by RECIST version 1.1. |
2 years and 2 months
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Cohorts 1, 2, 3B, 4 and 5: Progression-free Survival (PFS)
Časové okno: 2 years and 2 months
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PFS is defined as the time from the first administration of study treatment until the date of objective disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1. |
2 years and 2 months
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Cohorts 1, 2, 3B, 4, 5 and 6: Overall Survival (OS)
Časové okno: 2 years and 2 months
|
OS is defined as the time from the first administration of study treatment until the date of death due to any cause. |
2 years and 2 months
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Cohorts 1, 2, 3B, 4, 5 and 6: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
Časové okno: 2 years and 1 month
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse events. |
2 years and 1 month
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Cohort 1 and 4: Maximum Observed Serum Concentration (Cmax) of Amivantamab
Časové okno: Predose up to 168 hours post dose on Day 1
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Cmax is defined as maximum observed serum concentration of amivantamab. |
Predose up to 168 hours post dose on Day 1
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Cohort 1 and 4: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab
Časové okno: Predose up to 168 hours post dose on Day 1
|
Tmax is defined as time to maximum observed serum concentration of amivantamab. |
Predose up to 168 hours post dose on Day 1
|
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Cohort 1 and 4: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab
Časové okno: Predose up to 168 hours post dose on Day 1
|
AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of amivantamab. |
Predose up to 168 hours post dose on Day 1
|
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Cohort 1 and 4: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab
Časové okno: Predose up to 168 hours post dose on Day 1
|
AUC(0-tau) is defined as area under the curve from time 0 to tau hours of amivantamab. |
Predose up to 168 hours post dose on Day 1
|
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Cohort 1 and 4: Trough Serum Concentration (Ctrough) of Amivantamab
Časové okno: Predose up to 168 hours post dose on Day 1
|
Ctrough is defined as the serum concentration of amivantamab. |
Predose up to 168 hours post dose on Day 1
|
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Cohort 1 and 4: Accumulation Ratio (R) of Amivantamab
Časové okno: Predose up to 168 hours post dose on Day 1
|
Accumulation ratio (R) is calculated as area under the serum concentration-time curve from time zero to 168 hours (AUC[0-168]) value at Cycle 2 Day 1 dose divided by AUC(0-168) value after Cycle 1 Day 1 amivantamab dose. |
Predose up to 168 hours post dose on Day 1
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Cohort 6: Event-Free Survival (EFS)
Časové okno: 2 years and 2 months
|
EFS is defined as the time from the first administration of study treatment until the date of radiographic disease progression, local or distant progression or recurrence as assessed with imaging or biopsy as indicated, or death due to any cause. |
2 years and 2 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Novotvary podle histologického typu
- Novotvary hlavy a krku
- Novotvary, žlázové a epiteliální
- Karcinom
- Karcinom, skvamózní buňky
- Spinocelulární karcinom hlavy a krku
- Organické chemikálie
- Uhlovodíky
- Cykloparafiny
- Uhlovodíky, alicyklické
- Uhlovodíky, cyklické
- Terpeny
- Koordinační komplexy
- Taxoidy
- Cyclodecanes
- Diterpeny
- Karboplatina
- Paklitaxel
- Pembrolizumab
- Amivantamab
Další identifikační čísla studie
Další identifikační čísla studie
- 61186372HNC2002
- 61186372HNC2002 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2023-508418-40-00 (Identifikátor registru: EUCT number)
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Studuje lékový produkt regulovaný americkým FDA
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