PD-L1陽性（CPS≧1）の再発/転移性頭頸部扁平上皮がんの参加者における一次治療としてのINCAGN02385およびINCAGN02390との併用におけるレチンファンリマブの研究
PD-L1陽性（CPS≧ 1) 再発・転移性頭頸部扁平上皮がん
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).
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
アクセスの拡大
連絡先と場所
研究場所
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Arizona
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Scottsdale、Arizona、アメリカ、85259
- Mayo Clinic Rochester
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California
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Duarte、California、アメリカ、91010-9200
- City of Hope National Medical Center
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Irvine、California、アメリカ、92618
- City of Hope Orange County
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La Jolla、California、アメリカ、92093
- University of California San Diego Medical Center, Moores Cancer Center
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Lancaster、California、アメリカ、93534
- City of Hope-Antelope Valley
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Long Beach、California、アメリカ、90813
- City of Hope National Medical Center
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Long Beach、California、アメリカ、90805
- Innovative Clinical Research Institute
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San Francisco、California、アメリカ、94115
- University of California San Francisco Comprehensive Cancer Center
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District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20057
- Georgetown University
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Jacksonville
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Miami、Florida、アメリカ、33174
- Blessed Health Care
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Tampa、Florida、アメリカ、33612-9416
- Moffitt Cancer Center
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Illinois
-
Chicago、Illinois、アメリカ、60612
- University of Illinois At Chicago
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Iowa
-
Iowa City、Iowa、アメリカ、52242-1316
- University of Iowa
-
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Kansas
-
Kansas City、Kansas、アメリカ、66103
- University of Kansas Hospital Authority
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Maryland
-
Baltimore、Maryland、アメリカ、21201
- University of Maryland-Greenebaum Cancer Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Cancer Center
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Detroit、Michigan、アメリカ、48201
- Barbara Ann Karmanos Cancer Hospital
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New Jersey
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Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- Fox Chase Cancer Center
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Utah
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Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute At University of Utah
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia - Emily Couric Clinical Cancer Center
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Washington
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Kennewick、Washington、アメリカ、99336
- Kadlec Clinic Hematology and Oncology
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-
-
-
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Candiolo、イタリア、10060
- Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
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Milan、イタリア、20133
- Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
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Milan、イタリア、20141
- European Institute of Oncology
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Naples、イタリア、80131
- Istituto Nazionale Tumori Irccs Fondazione Pascale
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Padova、イタリア、35128
- Iov - Istituto Oncologico Veneto Irccs
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Pavia、イタリア、27100
- Fondazione Irccs Policlinico San Matteo
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Reggio Emilia、イタリア、42123
- Ausl-Irccs Di Reggio Emilia
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-
-
-
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Amsterdam、オランダ、1066 CX
- The Dutch Cancer Institue
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Leiden、オランダ、02333
- Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
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-
-
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Quebec
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Montreal、Quebec、カナダ、H3T 1E2
- McGill University Jewish General Hospital
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Montreal、Quebec、カナダ、H2X 3E4
- McGill University Health Centre/Glen Site/Cedars Cancer Centre
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Montreal、Quebec、カナダ、H2X3E4
- Chum Hospital Notre Dame
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-
-
-
-
Chaïdári、ギリシャ、12462
- University Hospital of West Attica - Attikon
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Thessaloniki、ギリシャ、54007
- Theagenio Anticancer Hospital
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Thessaloniki、ギリシャ、54622
- Bioclinic Thessaloniki (Galinos Clinic)
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Thessaloniki、ギリシャ、55236
- Saint Lukas Clinic
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-
-
-
-
K'ut'aisi、グルジア、04600
- Jsc Evex Hospitals
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Tbilisi、グルジア、00114
- New Hospitals
-
Tbilisi、グルジア、00159
- Jsc Evex Corporation-Caraps Medline
-
Tbilisi、グルジア、0159
- Ltd Cancer Research Centre
-
-
-
-
-
Barcelona、スペイン、08916
- Catalans Institute of Oncology Barcelona
-
Girona、スペイン、17007
- Ico Girona Hospital Universitari de Girona Dr Josep Trueta
-
Madrid、スペイン、28223
- Hospital Universitario Quironsalud Madrid
-
Madrid、スペイン、00034
- Fundacion Jimenez Diaz University Hospital
-
Madrid、スペイン、28036
- Hospital Universitario Ramon Y Cajal
-
Málaga、スペイン、29010
- Hospital Regional Universitario Carlos Haya
-
Pamplona、スペイン、31008
- Complejo Hospitalario de Navarra
-
Santander、スペイン、39008
- Hospital Universitario Marques de Valdecilla
-
Valencia、スペイン、46014
- Hospital General Universitario de Valencia
-
Valencia、スペイン、46026
- Hospital Universitari I Politecnic La Fe
-
-
-
-
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Cologne、ドイツ、50937
- University of Cologne
-
Hamburg、ドイツ、22763
- Asklepios Klinik Altona
-
Hamburg、ドイツ、20246
- Universitatsklinikum Hamburg Eppendorf
-
Mainz、ドイツ、55131
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
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-
-
-
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Bordeaux、フランス、33000
- Centre Hospitalier Universitaire de Bordeaux
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Paris、フランス、75248
- Institut Curie
-
Rennes、フランス、35042
- Centre Eugene Marquis
-
Saint-Herblain、フランス、44805
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Strasbourg、フランス、67200
- Icans - Institut de Cancerologie Strasbourg Europe
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-
-
-
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Charleroi、ベルギー、06000
- Grand Hospital de Charleroi
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Hasselt、ベルギー、03500
- Jessa Ziekenhuis
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Wilrijk、ベルギー、02610
- Gza Sint Augustinus
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-
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-
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Braga、ポルトガル、4710-243
- Hospital de Braga
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Faro、ポルトガル、8000-386
- Centro Hospitalar Universitario Algarve
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Lisbon、ポルトガル、1649-035
- Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
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Porto、ポルトガル、4200-319
- Centro Hospitalar de Sao Joao Alameda
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Porto、ポルトガル、4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
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Vila Nova de Gaia、ポルトガル、4434-502
- Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
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Bydgoszcz、ポーランド、85-796
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
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Konin、ポーランド、62-500
- Przychodnia Lekarska Komed Roman Karaszewski
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Lublin、ポーランド、20-090
- Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
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Poznan、ポーランド、60-780
- Poznan University of Medical Sciences
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Tomaszów Mazowiecki、ポーランド、97-200
- Nzoz Provita Prolife Centrum Medyczne
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Warsaw、ポーランド、02-781
- Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
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Kaohsiung City、台湾、80708
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City、台湾、83301
- Chang Gung Medical Foundation. Kaohsiung Branch
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Taichung、台湾、00112
- China Medical University Hospital
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Taipei、台湾、10002
- National Taiwan University Hospital
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Taipei、台湾、00112
- Institutional Review Board Taipei Veterans General Hospital
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Busan、韓国、49241
- Pusan National University Yangsan Hospital
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Gwangju、韓国、58128
- Chonnam National University Hwasun Hospital
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Seongnam-si、韓国、13496
- Cha Bundang Medical Center
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Seoul、韓国、05505
- Asan Medical Center
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Seoul、韓国、03181
- Kangbuk Samsung Hospital
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Seoul、韓国、02841
- Korea University Anam Hospital
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Seoul、韓国、05030
- Kunkuk University Medical Center
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Yangsan、韓国、50612
- Pusan National University Yangsan Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. Placebo will be administered intravenously. |
|
実験的：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. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. Placebo will be administered intravenously. INCAGN02385 350mg will be administered intravenously every 2 weeks. |
|
実験的：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. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. INCAGN02385 350mg will be administered intravenously every 2 weeks. INCAGN02390 400 mg will be administered intravenously every 2 weeks. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progeression-free Survival (PFS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Response
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- INCAGN 2385-203
- 2021-005775-39 (EudraCT番号)
- 2023-504270-38-00 (レジストリ識別子：EU CT Number)
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。