A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (RAGNAR)

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Erdafitinib

Detailed Description

Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations in the FGFR pathway. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered as the time when the last participant receives the last dose of study drug on the study and either all pediatric participants are off study or until the most recently enrolled pediatric participant still participating in the study has 6 months of follow-up, whichever occurs first. Currently this study is recruiting pediatric participants only.

• Study Type: Interventional
• Enrollment (Actual): 316
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman
  • Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Ciudad Autonoma de Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
  • Ciudad Autonoma de Buenos Aires, Argentina, C1428AQK
    • Instituto Fleni
  • Ciudad Autónoma de Buenos Aires, Argentina, C1012AAR
    • Instituto de Investigaciones Metabolicas
  • Cordoba, Argentina, 5000
    • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • La Plata Lpl Lpl, Argentina, 1900
    • Hospital Italiano de la Plata
  • Mar Del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Mar Del Plata, Buenos Aires, Argentina, B7600FZN
    • Instituto de Investigaciones Clínicas Mar del Plata
  • Pilar, Argentina, 1629
    • Hospital Universitario Austral
  • Rosario, Argentina, 2000
    • Sanatorio Británico de Rosario
  • San Salvador De Jujuy, Argentina, Y4600AFW
    • ARS Medica
• Australia
  • Adelaide, Australia, 5042
    • Flinders Centre for Innovation in Cancer
  • Camperdown, Australia, 2050
    • Chris O'Brien Lifehouse
  • Darlinghurst, Australia, 2010
    • St. Vincent's Hospital Sydney
  • Fitzroy, Australia, 3065
    • St Vincents Hospital Melbourne
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • South Brisbane, Australia, 4101
    • Intergrated Clinical Oncology Network Pty Ltd (ICON)
• Belgium
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Bruxelles, Belgium, 1200
    • UCL Hopital Saint-Luc
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi, site Notre Dame
  • Dinant, Belgium, 5500
    • CHU UCL Namur - Site Dinant
  • Edegem, Belgium, 2650
    • UZA
  • Gent, Belgium, 9000
    • UZ Gent
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Haine-Saint-Paul, La Louviere, Belgium, 7100
    • Jolimont
  • Namur, Belgium, 5000
    • CHU UCL Namur - Site Sainte Elisabeth
  • Ottignies, Belgium, 1340
    • Cliniques St Pierre
  • Yvoir, Belgium, 5530
    • CHU UCL Namur - site Godinne
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação PIO XII
  • Curitiba, Brazil, 81520-060
    • Liga Paranaense de Combate ao Cancer
  • Goiania, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Ijui, Brazil, 98700-000
    • Associação Hospital de Caridade Ijuí
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra O Câncer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Recife, Brazil, 50070-550
    • Instituto de Medicina Integral Professor Fernando Figueira
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Rio de Janeiro, Brazil, 22281-100
    • Instituto D Or de Pesquisa e Ensino (IDOR)
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael
  • Sao Paulo, Brazil, 01246-000
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • Sao Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01321-001
    • Real e Benemérita Associação Portuguesa de Beneficência
  • São Paulo, Brazil, 01308-901
    • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • São Paulo, Brazil, 05410-030
    • Hospital das Clínicas da Faculdade de Medicina da USP
  • São Paulo, Brazil, 4039001
    • GRAACC
• China
  • Beijing, China, 100853
    • Chinese PLA General hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100070
    • Beijing Tiantan Hospital, Capital Medical University
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 101100
    • Beijing Luhe Hospital, Capital Medical University
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changchun, China, 130012
    • Jilin Cancer Hospital
  • Chengdu, China, 610041
    • West China Hospital,Sichuan University
  • Chongqing, China, 400038
    • Chongqing Southwest Hospital
  • Chongqing, China, 400042
    • Third Military Medical University Daping Hospital Cancer Center
  • Guangzhou, China, 510289
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310003
    • First Affiliated Hospital of Zhejiang University
  • Nanjing, China, 210002
    • Eastern Theater General Hospital, Qinhuai District Medical Area
  • Shanghai, China, 200032
    • Shanghai Zhongshan Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University
  • Shanghai, China, 200032
    • Cancer Hospital, FuDan University
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
• France
  • Bordeaux, France, 33075
    • Hopital Saint Andre
  • Caen, France, 14000
    • Centre Francois Baclesse
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21000
    • centre Georges François Leclerc
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Marseille, France, 130005
    • Hôpital de la Timone
  • Paris, France, 75005
    • Institut Curie
  • Poitiers, France, 86021
    • Chu de Poitiers
  • Vandoeuvre lès Nancy, France, 54519
    • Institut de Cancérologie de Lorraine
  • Villejuif, France, 94800
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10115
    • Charité
  • Dresden, Germany, 01307
    • Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Frankfurt, Germany, 60385
    • Universitaetsklinikum Frankfurt
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Köln, Germany, 50937
    • Universitaetsklinikum Koeln
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • München, Germany, 81675
    • Klinikum Rechts der Isar der TU München
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Monza, Italy, 20900
    • Asst Di Monza
  • Napoli, Italy, 80138
    • Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
  • Napoli, Italy, 80138
    • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
  • Perugia, Italy, 06132
    • Ospedale S. Maria Della Misericordia
  • Pisa, Italy, 56126
    • Ospedale Santa Chiara AO Universitaria Pisana
  • Terni, Italy, 5100
    • Azienda Ospedaliera S. Maria Terni
  • Verona, Italy, 37134
    • Ospedale Borgo Roma
• Japan
  • Chuo-Ku, Japan, 104-0045
    • National Cancer Center Hospital
  • Hiroshima-shi, Japan, 734-8551
    • Hiroshima University Hospital
  • Kashiwa, Japan, 277 8577
    • National Cancer Center Hospital East
  • Matsuyama, Japan, 791-0280
    • National Hospital Organizaiton Shikoku Cancer Center
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 3080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St. Mary'S Hospital
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED Roman Karaszewski
  • Krakow, Poland, 31-501
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
  • Lodz, Poland, 93-513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Skorzewo, Poland, 60-185
    • Centrum Medyczne Pratia Poznan
  • Warszawa, Poland, 01-211
    • Instytut Matki i Dziecka
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Warszawa, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
• Spain
  • Barcelona, Spain, 08035
    • Hosp. Univ. Vall D Hebron
  • Barcelona, Spain, 08028
    • Hosp. Univ. Quiron Dexeus
  • Barcelona, Spain, 08950
    • Hosp. Sant Joan de Deu
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Hospitalet de Llobregat, Barcelona, Spain, 08908
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Madrid, Spain, 28040
    • Hosp. Univ. Fund. Jimenez Diaz
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28027
    • Clinica Univ. de Navarra
  • Madrid, Spain, 28009
    • Hosp. Infantil Univ. Nino Jesus
  • Sevilla, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 833
    • Chang Gung Medical Foundation
  • Kaohsiung City, Taiwan, 82445
    • E-DA Cancer Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 403
    • China Medical University Hospital
  • Tainan, Taiwan, 736
    • Chi Mei Medical Center - Liu Ying
  • Tainan, Taiwan, 710
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center Yong Kang
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou Branch
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Bristol, United Kingdom, BS2 8AE
    • Bristol Royal Hospital for Children
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Trust
  • Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC - HOPE
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
  • Georgia
    • Atlanta, Georgia, United States, 30022
      • Emory University
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Hawaii Cancer Care
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
    • New York, New York, United States, 10128
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute, Carolinas HealthCare System
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology-Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • MD Anderson
    • Houston, Texas, United States, 77030
      • Oncology Consultants - Texas
    • Odessa, Texas, United States, 79761
      • Texas Oncology Odessa-West Texas Cancer Center
    • San Antonio, Texas, United States, 78217
      • Texas Oncology San Antonio Northeast
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties, PLLC
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Aurora Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
• Measurable disease
• Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
• Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening

Exclusion Criteria:

• Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
• The presence of FGFR gatekeeper and resistance mutations
• Histologic demonstration of urothelial carcinoma
• Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
• For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS
• Active malignancies other than for disease requiring therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Erdafitinib; Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of erdafitinib oral tablets until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.

Drug: Erdafitinib; Participants will receive erdafitinib oral tablets.; Other Names: JNJ-42756493

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)	ORR as assessed by IRC is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR).	Up to 6 years and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate as Assessed by Investigator	ORR as assessed by investigator is defined as the percentage of participants who achieve a CR or PR.	Up to 6 years and 9 months
Duration of Response (DOR)	DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.	Up to 6 years and 9 months
Disease Control Rate (DCR)	DCR is defined as the percentage of participants with CR, PR or stable disease (SD).	Up to 6 years and 9 months
Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with CR, PR or durable SD.	Up to 6 years and 9 months
Progression Free Survival (PFS)	PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.	Up to 6 years and 9 months
Overall Survival (OS)	OS will be measured from the date of first dose of study drug to the date of the participant's death.	Up to 6 years and 9 months
Plasma Concentrations of Erdafitinib	Plasma concentrations of erdafitinib will be reported.	Predose and 2-4 hours postdose
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the relevant investigational product.	Up to 6 years and 9 months
Number of Participants with Adverse Events by Severity	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Adverse event severity is a clinical determination of the intensity of an adverse event.	Up to 6 years and 9 months
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score	The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.	Baseline; up to 2 years and 9 months
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score	The PGIS is a single question regarding the patient report of disease severity: considering all aspects of your cancer symptoms right now would you say your cancer symptoms are none, mild, moderate, severe, or very severe?	Baseline; up to 2 years and 9 months
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Change (PGIC) Scale	The PGIC is the patient-reported outcome (PRO) counterpart to the clinical global impressions (CGI) scale. The PGIC is a single verbal rating scale ranging from 1 = a lot better now to 7 = a lot worse now.	Baseline; up to 2 years and 9 months
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score	The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline; up to 2 years and 9 months
Change from Baseline in Pediatric Functional Assessment of Cancer Therapy - Brain (Peds FACT-Br) Total Score	Peds FACT-Br consists of 4 sets of disease-specific questions pertaining to brain neoplasms (a set of 34 to 37 questions each for child, parent of child, adolescent or parent of adolescent). Peds FACT-Br total score for child ranges from 0-136 and for parent of child, adolescent and parent of adolescent the score ranges from 0-148. Here '0' indicates a severely "symptomatic participant" and highest score indicates "asymptomatic participant".	Baseline; up to 2 years and 9 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): August 15, 2022
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CR108661; 2019-002113-19 (EudraCT Number); 42756493CAN2002 (Other Identifier: Janssen Research & Development, LLC); 2023-510301-18-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No