치료되지 않은 진행성 흑색종 참가자에서 펨브롤리주맙 단독 요법과 비교하여 리필루셀 요법과 펨브롤리주맙을 조사하기 위한 연구.
참가자를 대상으로 펨브롤리주맙 단독 요법과 비교하여 펨브롤리주맙과 병용한 Lifileucel(LN-144, 자가 종양 침윤 림프구[TIL]) 요법의 효능 및 안전성을 평가하기 위한 3상, 다기관, 무작위, 공개 라벨, 병렬 그룹, 치료 연구 치료되지 않은 절제 불가능 또는 전이성 흑색종
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.
연구 개요
상태
상세 설명
The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer [AJCC] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.
연구 유형
등록 (추정된)
단계
- 3단계
확장된 액세스
연락처 및 위치
연구 연락처
- 이름: Iovance Biotherapeutics Study Team
- 전화번호: 1-844-845-4682
- 이메일: Clinical.Inquiries@iovance.com
연구 연락처 백업
- 이름: Iovance Biotherapeutics https://www.tilvance-301.com
- 전화번호: 1-844-845-4682
- 이메일: Clinical.Inquiries@iovance.com
연구 장소
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Amsterdam, 네덜란드, 1066 CX
- 모병
- Nederlands Kanker Instituut
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Seoul, 대한민국, 3722
- 모병
- Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 3080
- 모병
- Seoul National University Hospital
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Seoul, 대한민국, 2841
- 모병
- Korea University Anam Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, 대한민국
- 모병
- Bundang Medical Center - CHA University
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South Korea
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Seoul, South Korea, 대한민국, 135-890
- 모병
- Samsung Medical Center
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Dresden, 독일, 1307
- 모병
- Universitätsklinikum Carl Gustav Carus
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Hamburg, 독일, 20251
- 모병
- Universitätsklinikum Hamburg-Eppendorf
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Lübeck, 독일, 23562
- 모병
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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Munich, 독일, 81675
- 모병
- Klinikum Rechts der Isar der Technischen Universität München
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Germany
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Berlin, Germany, 독일, 13353
- 모병
- Charité - Universitätsmedizin Berlin
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Würzburg, Germany, 독일, 97080
- 모병
- Universitätsklinikum Würzburg
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Alabama
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Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama at Birmingham: The Kirklin Clinic
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California
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Duarte, California, 미국, 91010
- 모병
- City of Hope
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Los Angeles, California, 미국, 90007
- 모병
- USC Norris Comprehensive Cancer Center
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San Francisco, California, 미국, 94107
- 빼는
- California Pacific Medical Center
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Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- University of Colorado Cancer Center
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Florida
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Orlando, Florida, 미국, 32806
- 모병
- Orlando Health Cancer Institute
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Illinois
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Chicago, Illinois, 미국, 60612
- 빼는
- University of Illinois Hospital & Health Sciences System
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Kansas
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Kansas City, Kansas, 미국, 66205
- 빼는
- University of Kansas
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Kentucky
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Louisville, Kentucky, 미국, 40202
- 빼는
- University of Louisville - James Graham Brown Cancer Center
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Maryland
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Bethesda, Maryland, 미국, 20814
- 모병
- National Cancer Institute
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Michigan
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Detroit, Michigan, 미국, 48201
- 빼는
- Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
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Detroit, Michigan, 미국, 48202
- 빼는
- Henry Ford Health
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- 모병
- University of Minnesota
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- 모병
- Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center
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New Jersey
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Camden, New Jersey, 미국, 08103
- 모병
- MD Anderson Cancer Center at Cooper
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Ohio
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Cincinnati, Ohio, 미국, 45226
- 모병
- Oncology Hematology Care
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Columbus, Ohio, 미국, 43201
- 모병
- Ohio State University
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Pennsylvania
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Easton, Pennsylvania, 미국, 18045
- 빼는
- St. Luke's Cancer Center - Anderson
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Pittsburgh, Pennsylvania, 미국, 15224
- 모병
- Allegheny Health Network
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Tennessee
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Bartlett, Tennessee, 미국, 37920
- 모병
- Baptist Cancer Center
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Nashville, Tennessee, 미국, 37203
- 모병
- SCRI Oncology Partners
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Utah
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Salt Lake City, Utah, 미국, 84112
- 모병
- Intermountain Health
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Virginia
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Richmond, Virginia, 미국, 23298
- 빼는
- Virginia Commonwealth University
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Washington
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Edmonds, Washington, 미국, 98026
- 모병
- Swedish Cancer Institute
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Jette, 벨기에
- 모병
- Universitair Ziekenhuis Brussel - Oncologisch Centrum
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Västra Götaland County
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Gothenburg, Västra Götaland County, 스웨덴, SE-41346
- 모병
- Sahlgrenska Universitetssjukhuset
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Lausanne, 스위스, 1011
- 모병
- Centre Hospitalier Universitaire Vaudois Lausanne
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Barcelona, 스페인, 8036
- 모병
- Hospital Clinic de Barcelona
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Barcelona, 스페인, 08028
- 모병
- Instituto Oncologico Rosell
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Barcelona, 스페인, 08035
- 빼는
- Hospital Universitari Vall dHebron
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Barcelona, 스페인, 8908
- 모병
- ICO l'Hospitalet - Hospital Duran i Reynals
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Madrid, 스페인, 28041
- 모병
- Hospital 12 de Octubre
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Madrid, 스페인
- 모병
- Hospital Universitario Ramon y Cajal
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Madrid, 스페인, 28050
- 모병
- Hospital Universitario Madrid Sanchinarro - CIOCC
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Madrid, 스페인, 28007
- 모병
- Hospital General Universitario Gregorio Maranon
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Madrid, 스페인, 28223
- 모병
- Hospital Universitario Quirónsalud Madrid
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Pamplona, 스페인, 31008
- 모병
- Clínica Universitaria de Navarra
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Seville, 스페인, 41009
- 모병
- Hospital Universitario Virgen Macarena
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Valencia, 스페인, 46014
- 모병
- Consorcio Hospital General Universitario de Valencia
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Cantabria
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Santander, Cantabria, 스페인, 39008
- 모병
- Hospital Universitario Marques de Valdecilla
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Málaga
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Málaga, Málaga, 스페인, 29016
- 모병
- Hospital Regional Universitario de Malaga - Hospital General
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Spain
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Barcelona, Spain, 스페인, 8908
- 모병
- Institut Català d'Oncologia (ICO)
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Madrid, Spain, 스페인, 28050
- 모병
- HM Centro Integral Oncologico Clara Campal
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Singapore
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Singapore, Singapore, 싱가포르, 168582
- 모병
- National Cancer Centre Singapore
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Glasgow, 영국, G120YN
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- Beaston West of Scotland Canter Centre
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London, 영국, W1G 6AD
- 모병
- Sarah Cannon Research Institute UK
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London, 영국, SE1 9RT
- 모병
- Guy's Hospital
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England
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Birmingham, England, 영국, B15 2GW
- 모병
- Queen Elizabeth Hospital Birmingham
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Newcastle upon Tyne, England, 영국, NE7 7DN
- 모병
- Freeman Hospital
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London
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Chelsea, London, 영국, SW3 6JJ
- 모병
- Royal Marsden Hospital
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Jerusalem, 이스라엘
- 모병
- Hadassah Medical Center
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Ramat Gan, 이스라엘, 52621
- 모병
- Sheba Medical Center
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Tel Aviv, 이스라엘, 6423906
- 빼는
- Tel Aviv Sourasky Medical Center
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Milan, 이탈리아, 20139
- 빼는
- Istituto Europeo Di Oncologia
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Siena, 이탈리아
- 모병
- Azienda Ospedaliera Universitaria Senese
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Forlì-Cesena
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Meldola, Forlì-Cesena, 이탈리아, 47014
- 모병
- Istituto Romagnolo per lo Studio dei Tumori
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Friuli Venezia Giulia
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Aviano, Friuli Venezia Giulia, 이탈리아, 33081
- 모병
- Centro di Riferimento Oncologico IRCCS
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Napoli
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Naples, Napoli, 이탈리아, 80131
- 모병
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
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Tuscany
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Pisa, Tuscany, 이탈리아, 56100
- 모병
- Azienda Ospedaliero Universitaria Pisana
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Toronto, 캐나다, M5G
- 모병
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, 캐나다, H2L 4M1
- 모병
- Centre hospitalier de l'Université de Montréal
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Marseille, 프랑스, 13009
- 모병
- Institut Paoli Calmettes
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Nantes, 프랑스, 44093
- 모병
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
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Paris, 프랑스, 75475
- 모병
- Hopital Saint Louis
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Finland
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Helsinki, Finland, 핀란드, 290
- 모병
- Helsinki University Hospital Comprehensive Cancer Center
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Bedford Park, 호주, 5042
- 모병
- Flinders Medical Centre
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Westmead, 호주, NSW 2145
- 모병
- Westmead Hospital
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Queensland
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Greenslopes, Queensland, 호주, 4120
- 모병
- Greenslopes Private Hospital
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Victoria
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Melbourne, Victoria, 호주, 3000
- 모병
- Peter MacCallum Cancer Centre
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Western Australia
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Murdoch, Western Australia, 호주, 6150
- 모병
- Fiona Stanley Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of > 6 months.
- Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
- Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
- Participants must have adequate organ function.
- Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria:
- Participant has melanoma of uveal/ocular origin.
- Participant has symptomatic untreated brain metastases.
- Participant received more than 1 prior line of therapy.
- Participant received prior therapy for metastatic disease
- Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
- Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
- Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated >1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
- Participant has a history of allogeneic cell or organ transplant.
Other protocol defined inclusion/exclusion criteria could apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm A
Lifileucel plus Pembrolizumab |
A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.
다른 이름들:
|
|
활성 비교기: Arm B
Pembrolizumab alone with Optional Crossover Period |
Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria. Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response Rate and Progression Free Survival
기간: 5 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by objective response rate (ORR) and progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
5 years total duration
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival
기간: 7 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by overall survival (OS) |
7 years total duration
|
|
Complete Response Rate, Duration of Response and Event Free Survival
기간: 5 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by complete response (CR) rate and duration of response (DOR) and event- free survival (EFS) assessed by the BIRC per RECIST v1.1 |
5 years total duration
|
|
Objective Response Rate, Progression Free Survival, Complete Response Rate, Duration of Responses, Event Free Survival and PFS2
기간: 5 years total duration
|
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by ORR, PFS, CR rate, DOR, and EFS assessed by the investigator per RECIST v1.1 and PFS2 assessed by the investigator |
5 years total duration
|
|
Adverse Events
기간: 5 years total duration
|
To characterize the safety and tolerability profile of lifileucel plus pembrolizumab and pembrolizumab alone in participants with unresectable or metastatic melanoma |
5 years total duration
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Iovance Biotherapeutics Study Team, Iovance Biotherapeutics
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IOV-MEL-301
- TILVANCE-301 (기타 식별자: Iovance Biotherapeutics, Inc.)
- TILVANCE (기타 식별자: Iovance Biotherapeutics, Inc.)
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. .