En studie av Amivantamab alene eller i tillegg til andre behandlingsmidler hos deltakere med tilbakevendende/metastatisk hode- og nakkekreft (OrigAMI-4)
En fase 1b/2, åpen studie av Amivantamab monoterapi og Amivantamab i tillegg til standardbehandlingsterapeutiske midler hos deltakere med tilbakevendende/metastatisk hode- og nakkeplateepitelkarsinom
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).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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California
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La Jolla, California, Forente stater, 92093
- Fullført
- University of California at San Diego Moores Cancer Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Denver Anschultz Medical Campus
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Connecticut
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New Haven, Connecticut, Forente stater, 06520
- Rekruttering
- Yale Cancer Center
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- The University of Chicago Medical Center (UCMC)
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- University of Maryland School of Medicine
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Rekruttering
- University of Michigan Rogel Cancer Center
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Detroit, Michigan, Forente stater, 48201 2013
- Rekruttering
- Karmanos Cancer Institute
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University School Of Medicine
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Rekruttering
- Rutgers Cancer Institute of New Jersey
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Rekruttering
- University of Utah Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, Forente stater, 22903
- Rekruttering
- University of Virginia
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Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists
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Avignon, Frankrike, 84918
- Rekruttering
- Institut Sainte Catherine
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Lille, Frankrike, 59000
- Rekruttering
- Centre Oscar Lambret
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Nantes, Frankrike, 44000
- Rekruttering
- CHU Nantes
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Paris, Frankrike, 75248
- Rekruttering
- Institut Curie
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Villejuif, Frankrike, 94805
- Rekruttering
- Gustave Roussy
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Nagoya, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center
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Tokyo, Japan, 160-0023
- Rekruttering
- Tokyo Medical University Hospital
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Beijing, Kina, 100142
- Fullført
- Beijing Cancer Hospital of Peking University
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Cheng Du Shi, Kina, 610041
- Rekruttering
- West China School of Medicine/West China Hospital, Sichuan University
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Linyi, Kina, 276002
- Fullført
- Linyi Cancer Hospital
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Shanghai, Kina, 200120
- Rekruttering
- Shanghai East Hospital
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Shanghai, Kina, 200032
- Rekruttering
- Fudan Cancer Hospital
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Wuhan, Kina, 430022
- Rekruttering
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
- Pantai Hospital Kuala Lumpur
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Gdansk, Polen, 80 214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polen, 44-102
- Rekruttering
- Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
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Warsaw, Polen, 02 781
- Rekruttering
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Barcelona, Spania, 08908
- Rekruttering
- Inst. Cat. Doncologia-H Duran I Reynals
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Barcelona, Spania, 08035
- Rekruttering
- Hosp Univ Vall D Hebron
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Madrid, Spania, 28034
- Rekruttering
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spania, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Cambridge, Storbritannia, CB2 0QQ
- Rekruttering
- Addenbrooke's Hospital
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Guildford, Storbritannia, GU2 7XX
- Rekruttering
- The Royal Surrey County Hospital NHS Foundation Trust
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London, Storbritannia, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital
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London, Storbritannia, W1T 7HA
- Rekruttering
- University College London Hospitals
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London, Storbritannia, SM2 5PT
- Rekruttering
- Royal Marsden Hospital (Sutton)
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London, Storbritannia, W12 0HS
- Fullført
- Imperial College London and Imperial College Healthcare NHS Trust
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Manchester, Storbritannia, M20 4BX
- Rekruttering
- The Christie Nhs Foundation Trust
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Changhua, Taiwan, 500
- Rekruttering
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 833
- Rekruttering
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Taipei, Taiwan, 112
- Rekruttering
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 33382
- Rekruttering
- Linkou Chang Gung Memorial Hospital
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Essen, Tyskland, 45147
- Rekruttering
- Universitaetsklinikum Essen
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Leipzig, Tyskland, 04103
- Fullført
- Universitaetsklinikum Leipzig
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Stuttgart, Tyskland, 70174
- Rekruttering
- Klinikum der Landeshauptstadt Stuttgart
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
Pembrolizumab will be administered intravenously.
Andre navn:
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Eksperimentell: 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.
Andre navn:
Paclitaxel will be administered intravenously.
Andre navn:
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Eksperimentell: 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.
Andre navn:
Paclitaxel will be administered intravenously.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
Pembrolizumab will be administered intravenously.
Andre navn:
Carboplatin will be administered intravenously.
Andre navn:
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Eksperimentell: 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.
Andre navn:
Pembrolizumab will be administered intravenously.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 2 years and 2 months
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The participants who achieve MPR at the time of surgery. |
2 years and 2 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 2 years and 2 months
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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
|
|
Cohorts 1, 2, 3B, 4, 5 and 6: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
Tidsramme: 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
|
|
Cohort 1 and 4: Maximum Observed Serum Concentration (Cmax) of Amivantamab
Tidsramme: Predose up to 168 hours post dose on Day 1
|
Cmax is defined as maximum observed serum concentration of amivantamab. |
Predose up to 168 hours post dose on Day 1
|
|
Cohort 1 and 4: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab
Tidsramme: 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
|
|
Cohort 1 and 4: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab
Tidsramme: 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
|
|
Cohort 1 and 4: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab
Tidsramme: 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
|
|
Cohort 1 and 4: Trough Serum Concentration (Ctrough) of Amivantamab
Tidsramme: 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
|
|
Cohort 1 and 4: Accumulation Ratio (R) of Amivantamab
Tidsramme: 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
|
|
Cohort 6: Event-Free Survival (EFS)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Karsinom
- Karsinom, plateepitel
- Plateepitelkarsinom i hode og nakke
- Organiske kjemikalier
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Koordinasjonskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Karboplatin
- Paclitaxel
- pembrolizumab
- Amivantamab
Andre studie-ID-numre
- 61186372HNC2002
- 61186372HNC2002 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-508418-40-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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