재발성/전이성 두경부암 참가자를 대상으로 아미반타맙 단독 또는 다른 치료제와 병용 투여에 대한 연구 (OrigAMI-4)
재발성/전이성 두경부 편평 세포 암종 참가자를 대상으로 표준 치료 약물에 추가로 아미반타맙 단독요법 및 아미반타맙을 추가하는 1b/2상 공개 라벨 연구
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).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Changhua, 대만, 500
- 모병
- Changhua Christian Hospital
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Kaohsiung City, 대만, 833
- 모병
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital
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Taipei, 대만, 112
- 모병
- Taipei Veterans General Hospital
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Taoyuan, 대만, 33382
- 모병
- Linkou Chang Gung Memorial Hospital
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Seoul, 대한민국, 05505
- 모병
- Asan Medical Center
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Seoul, 대한민국, 03080
- 모병
- Seoul National University Hospital
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Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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Seoul, 대한민국, 03722
- 모병
- Severance Hospital Yonsei University Health System
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Essen, 독일, 45147
- 모병
- Universitaetsklinikum Essen
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Leipzig, 독일, 04103
- 완전한
- Universitaetsklinikum Leipzig
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Stuttgart, 독일, 70174
- 모병
- Klinikum der Landeshauptstadt Stuttgart
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Kuala Lumpur, 말레이시아, 59100
- 모병
- University Malaya Medical Centre
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Kuala Lumpur, 말레이시아, 59100
- 모병
- Pantai Hospital Kuala Lumpur
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California
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La Jolla, California, 미국, 92093
- 완전한
- University of California at San Diego Moores Cancer Center
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Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- University of Colorado Denver Anschultz Medical Campus
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Connecticut
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New Haven, Connecticut, 미국, 06520
- 모병
- Yale Cancer Center
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Illinois
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Chicago, Illinois, 미국, 60637
- 모병
- The University of Chicago Medical Center (UCMC)
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Maryland
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Baltimore, Maryland, 미국, 21201
- 모병
- University of Maryland School of Medicine
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- 모병
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan Rogel Cancer Center
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Detroit, Michigan, 미국, 48201 2013
- 모병
- Karmanos Cancer Institute
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Washington University School Of Medicine
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New Jersey
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New Brunswick, New Jersey, 미국, 08901
- 모병
- Rutgers Cancer Institute of New Jersey
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- 모병
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, 미국, 44195
- 모병
- Cleveland Clinic
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Utah
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Salt Lake City, Utah, 미국, 84112
- 모병
- University of Utah Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, 미국, 22903
- 모병
- University of Virginia
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Fairfax, Virginia, 미국, 22031
- 모병
- Virginia Cancer Specialists
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Barcelona, 스페인, 08908
- 모병
- Inst. Cat. Doncologia-H Duran I Reynals
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Barcelona, 스페인, 08035
- 모병
- Hosp Univ Vall D Hebron
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Madrid, 스페인, 28034
- 모병
- Hosp. Univ. Ramon Y Cajal
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Madrid, 스페인, 28041
- 모병
- Hosp. Univ. 12 de Octubre
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Cambridge, 영국, CB2 0QQ
- 모병
- Addenbrooke's Hospital
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Guildford, 영국, GU2 7XX
- 모병
- The Royal Surrey County Hospital NHS Foundation Trust
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London, 영국, SW3 6JJ
- 모병
- Royal Marsden Hospital
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London, 영국, W1T 7HA
- 모병
- University College London Hospitals
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London, 영국, SM2 5PT
- 모병
- Royal Marsden Hospital (Sutton)
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London, 영국, W12 0HS
- 완전한
- Imperial College London and Imperial College Healthcare NHS Trust
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Manchester, 영국, M20 4BX
- 모병
- The Christie Nhs Foundation Trust
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Nagoya, 일본, 464-8681
- 모병
- Aichi Cancer Center
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Tokyo, 일본, 160-0023
- 모병
- Tokyo Medical University Hospital
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Beijing, 중국, 100142
- 완전한
- Beijing Cancer Hospital of Peking University
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Cheng Du Shi, 중국, 610041
- 모병
- West China School of Medicine/West China Hospital, Sichuan University
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Linyi, 중국, 276002
- 완전한
- Linyi Cancer Hospital
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Shanghai, 중국, 200120
- 모병
- Shanghai East Hospital
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Shanghai, 중국, 200032
- 모병
- Fudan Cancer Hospital
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Wuhan, 중국, 430022
- 모병
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology
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Gdansk, 폴란드, 80 214
- 모병
- Uniwersyteckie Centrum Kliniczne
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Gliwice, 폴란드, 44-102
- 모병
- Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
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Warsaw, 폴란드, 02 781
- 모병
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Avignon, 프랑스, 84918
- 모병
- Institut Sainte Catherine
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Lille, 프랑스, 59000
- 모병
- Centre Oscar Lambret
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Nantes, 프랑스, 44000
- 모병
- CHU Nantes
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Paris, 프랑스, 75248
- 모병
- Institut Curie
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Villejuif, 프랑스, 94805
- 모병
- Gustave Roussy
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Pembrolizumab will be administered intravenously.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Paclitaxel will be administered intravenously.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Paclitaxel will be administered intravenously.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Pembrolizumab will be administered intravenously.
다른 이름들:
Carboplatin will be administered intravenously.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
Pembrolizumab will be administered intravenously.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
기간: 2 years and 2 months
|
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
|
|
Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)
기간: Up to 21 days
|
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
|
|
Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
기간: 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 event. |
2 years and 1 month
|
|
Cohort 6: Major Pathologic Response (MPR)
기간: 2 years and 2 months
|
The participants who achieve MPR at the time of surgery. |
2 years and 2 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR)
기간: 2 years and 2 months
|
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
|
|
Cohorts 1, 2, 3B, 4 and 5: Clinical Benefit Rate (CBR)
기간: 2 years and 2 months
|
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
|
|
Cohorts 1, 2, 3B, 4 and 5: Progression-free Survival (PFS)
기간: 2 years and 2 months
|
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
|
|
Cohorts 1, 2, 3B, 4, 5 and 6: Overall Survival (OS)
기간: 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
|
|
Cohorts 1, 2, 3B, 4, 5 and 6: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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추가 정보
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추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 61186372HNC2002
- 61186372HNC2002 (기타 식별자: Janssen Research & Development, LLC)
- 2023-508418-40-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .