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두경부의 PD-L1 양성(CPS ≥ 1) 재발성/전이성 편평 세포 암종 참가자를 대상으로 1차 치료로서 레틴판리맙과 INCAGN02385 및 INCAGN02390을 병용한 연구

2026년 9월 1일 업데이트: Incyte Biosciences International Sàrl

PD-L1 양성(CPS ≥ 1) 두경부의 재발성/전이성 편평세포암종

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

176

단계

  • 2 단계

확장된 액세스

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연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그루지야
      • K'ut'aisi, 그루지야, 04600
        • Jsc Evex Hospitals
      • Tbilisi, 그루지야, 00114
        • New Hospitals
      • Tbilisi, 그루지야, 00159
        • Jsc Evex Corporation-Caraps Medline
      • Tbilisi, 그루지야, 0159
        • Ltd Cancer Research Centre
  • 그리스
      • Chaïdári, 그리스, 12462
        • University Hospital of West Attica - Attikon
      • Thessaloniki, 그리스, 54007
        • Theagenio Anticancer Hospital
      • Thessaloniki, 그리스, 54622
        • Bioclinic Thessaloniki (Galinos Clinic)
      • Thessaloniki, 그리스, 55236
        • Saint Lukas Clinic
  • 네덜란드
      • Amsterdam, 네덜란드, 1066 CX
        • The Dutch Cancer Institue
      • Leiden, 네덜란드, 02333
        • Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
  • 대만
      • Kaohsiung City, 대만, 80708
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, 대만, 83301
        • Chang Gung Medical Foundation. Kaohsiung Branch
      • Taichung, 대만, 00112
        • China Medical University Hospital
      • Taipei, 대만, 10002
        • National Taiwan University Hospital
      • Taipei, 대만, 00112
        • Institutional Review Board Taipei Veterans General Hospital
  • 대한민국
      • Busan, 대한민국, 49241
        • Pusan National University Yangsan Hospital
      • Gwangju, 대한민국, 58128
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, 대한민국, 13496
        • Cha Bundang Medical Center
      • Seoul, 대한민국, 05505
        • Asan Medical Center
      • Seoul, 대한민국, 03181
        • Kangbuk Samsung Hospital
      • Seoul, 대한민국, 02841
        • Korea University Anam Hospital
      • Seoul, 대한민국, 05030
        • Kunkuk University Medical Center
      • Yangsan, 대한민국, 50612
        • Pusan National University Yangsan Hospital
  • 독일
      • Cologne, 독일, 50937
        • University of Cologne
      • Hamburg, 독일, 22763
        • Asklepios Klinik Altona
      • Hamburg, 독일, 20246
        • Universitatsklinikum Hamburg Eppendorf
      • Mainz, 독일, 55131
        • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85259
        • Mayo Clinic Rochester
    • California
      • Duarte, California, 미국, 91010-9200
        • City of Hope National Medical Center
      • Irvine, California, 미국, 92618
        • City of Hope Orange County
      • La Jolla, California, 미국, 92093
        • University of California San Diego Medical Center, Moores Cancer Center
      • Lancaster, California, 미국, 93534
        • City of Hope-Antelope Valley
      • Long Beach, California, 미국, 90813
        • City of Hope National Medical Center
      • Long Beach, California, 미국, 90805
        • Innovative Clinical Research Institute
      • San Francisco, California, 미국, 94115
        • University of California San Francisco Comprehensive Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20057
        • Georgetown University
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • Mayo Clinic Jacksonville
      • Miami, Florida, 미국, 33174
        • Blessed Health Care
      • Tampa, Florida, 미국, 33612-9416
        • Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • University of Illinois At Chicago
    • Iowa
      • Iowa City, Iowa, 미국, 52242-1316
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, 미국, 66103
        • University of Kansas Hospital Authority
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • University of Maryland-Greenebaum Cancer Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Cancer Center
      • Detroit, Michigan, 미국, 48201
        • Barbara Ann Karmanos Cancer Hospital
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • Hackensack University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19111
        • Fox Chase Cancer Center
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Huntsman Cancer Institute At University of Utah
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • University of Virginia - Emily Couric Clinical Cancer Center
    • Washington
      • Kennewick, Washington, 미국, 99336
        • Kadlec Clinic Hematology and Oncology
  • 벨기에
      • Charleroi, 벨기에, 06000
        • Grand Hospital de Charleroi
      • Hasselt, 벨기에, 03500
        • Jessa Ziekenhuis
      • Wilrijk, 벨기에, 02610
        • Gza Sint Augustinus
  • 스페인
      • Barcelona, 스페인, 08916
        • Catalans Institute of Oncology Barcelona
      • Girona, 스페인, 17007
        • Ico Girona Hospital Universitari de Girona Dr Josep Trueta
      • Madrid, 스페인, 28223
        • Hospital Universitario Quironsalud Madrid
      • Madrid, 스페인, 00034
        • Fundacion Jimenez Diaz University Hospital
      • Madrid, 스페인, 28036
        • Hospital Universitario Ramon Y Cajal
      • Málaga, 스페인, 29010
        • Hospital Regional Universitario Carlos Haya
      • Pamplona, 스페인, 31008
        • Complejo Hospitalario de Navarra
      • Santander, 스페인, 39008
        • Hospital Universitario Marques de Valdecilla
      • Valencia, 스페인, 46014
        • Hospital General Universitario de Valencia
      • Valencia, 스페인, 46026
        • Hospital Universitari I Politecnic La Fe
  • 이탈리아
      • Candiolo, 이탈리아, 10060
        • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
      • Milan, 이탈리아, 20133
        • Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
      • Milan, 이탈리아, 20141
        • European Institute of Oncology
      • Naples, 이탈리아, 80131
        • Istituto Nazionale Tumori Irccs Fondazione Pascale
      • Padova, 이탈리아, 35128
        • Iov - Istituto Oncologico Veneto Irccs
      • Pavia, 이탈리아, 27100
        • Fondazione Irccs Policlinico San Matteo
      • Reggio Emilia, 이탈리아, 42123
        • Ausl-Irccs Di Reggio Emilia
  • 캐나다
    • Quebec
      • Montreal, Quebec, 캐나다, H3T 1E2
        • McGill University Jewish General Hospital
      • Montreal, Quebec, 캐나다, H2X 3E4
        • McGill University Health Centre/Glen Site/Cedars Cancer Centre
      • Montreal, Quebec, 캐나다, H2X3E4
        • Chum Hospital Notre Dame
  • 포르투갈
      • Braga, 포르투갈, 4710-243
        • Hospital de Braga
      • Faro, 포르투갈, 8000-386
        • Centro Hospitalar Universitario Algarve
      • Lisbon, 포르투갈, 1649-035
        • Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
      • Porto, 포르투갈, 4200-319
        • Centro Hospitalar de Sao Joao Alameda
      • Porto, 포르투갈, 4200-072
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
      • Vila Nova de Gaia, 포르투갈, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
  • 폴란드
      • Bydgoszcz, 폴란드, 85-796
        • Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
      • Konin, 폴란드, 62-500
        • Przychodnia Lekarska Komed Roman Karaszewski
      • Lublin, 폴란드, 20-090
        • Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
      • Poznan, 폴란드, 60-780
        • Poznan University of Medical Sciences
      • Tomaszów Mazowiecki, 폴란드, 97-200
        • Nzoz Provita Prolife Centrum Medyczne
      • Warsaw, 폴란드, 02-781
        • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
  • 프랑스
      • Bordeaux, 프랑스, 33000
        • Centre Hospitalier Universitaire de Bordeaux
      • Paris, 프랑스, 75248
        • Institut Curie
      • Rennes, 프랑스, 35042
        • Centre Eugene Marquis
      • Saint-Herblain, 프랑스, 44805
        • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
      • Strasbourg, 프랑스, 67200
        • Icans - Institut de Cancerologie Strasbourg Europe

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent. Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible.
  • Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
  • Participants must not have received prior systemic therapy for R/M SCCHN.
  • PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination.
  • For participants with primary oropharyngeal tumors, documentation of HPV p16 status based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites.
  • Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
  • Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy.
  • ECOG performance status of 0 or 1.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy.
  • Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment.
  • Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding.
  • Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded.
  • Less than 3-month life expectancy.
  • Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
  • Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment.
  • Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months before the first dose of study treatment.
  • Known active CNS metastases and/or carcinomatous meningitis. Participants will be excluded if it has been < 4 weeks since radiation therapy was delivered to the CNS.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment Group 1: Retifanlimab Monotherapy

Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
의약품: Retifanlimab

Retifanlimab 500mg will be administered intravenously every 4 weeks.

의약품: Placebo

Placebo will be administered intravenously.
실험적: Treatment Group 2: Retifanlimab + INCAGN02385

Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
의약품: Retifanlimab

Retifanlimab 500mg will be administered intravenously every 4 weeks.

의약품: Placebo

Placebo will be administered intravenously.

의약품: INCAGN02385

INCAGN02385 350mg will be administered intravenously every 2 weeks.
실험적: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.
의약품: Retifanlimab

Retifanlimab 500mg will be administered intravenously every 4 weeks.

의약품: INCAGN02385

INCAGN02385 350mg will be administered intravenously every 2 weeks.

의약품: INCAGN02390

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progeression-free Survival (PFS)
기간: up to 738 days

PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first.
up to 738 days

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response
기간: up to approximately 44 months

Objective response was defined as having a complete response (CR) or partial response (PR), determined based on investigator assessment per RECIST v1.1, recorded post-baseline before and including the first progressive disease, and before new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to approximately 44 months
Duration of Response (DOR)
기간: up to approximately 44 months

DOR was defined as the time from earliest date of disease response (CR or PR) until the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.
up to approximately 44 months
Disease Control
기간: up to approximately 44 months

Disease control was defined as having CR, PR, or stable disease (SD) as best response on or after Day 180, based on investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44 months
Overall Survival
기간: up to approximately 44 months

Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
up to approximately 44 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
기간: up to approximately 44 months

Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug.
up to approximately 44 months
Number of Participants With TEAEs Leading to Treatment Interruption, Dose Delay, and Withdrawal of Study Treatment
기간: up to approximately 44 months

AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug.
up to approximately 44 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Incyte Biosciences International Sàrl

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 11월 14일

기본 완료 (실제)

2025년 3월 14일

연구 완료 (실제)

2026년 6월 23일

연구 등록 날짜

최초 제출

2022년 3월 11일

QC 기준을 충족하는 최초 제출

2022년 3월 11일

처음 게시됨 (실제)

2022년 3월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • INCAGN 2385-203
  • 2021-005775-39 (EudraCT 번호)
  • 2023-504270-38-00 (레지스트리 식별자: EU CT Number)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD 공유 기간

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD 공유 액세스 기준

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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. .

구독하다