AzTrials
AzTrials

Urinary Bladder NeoplasmsPhase 2NCT04172675

A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

A Phase 2 study testing Erdafitinib, Investigator Choice (Gemcitabine) and Investigator Choice (Mitomycin C) in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 150 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
What is being tested?
Erdafitinib, Investigator Choice (Gemcitabine) and Investigator Choice (Mitomycin C)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
150 sitesin 17 countries
Study dates
28 Feb 2020to 27 Feb 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
  • Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
  • Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
  • Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
  • Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • A woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
  • Adequate bone marrow, liver, and renal function as specified in the protocol

Who cannot join

  • Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
  • Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder
  • Prior treatment with an FGFR inhibitor
  • Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
  • Current central serous retinopathy or retinal pigment epithelial detachment of any grade

Trial locations and contacts

150 sites in 17 countries.

150 sites in 17 countries

United States22 sites

  • Albany Medical College

    Albany, New York, 12208

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • The Urology Group

    Cincinnati, Ohio, 45212

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio, 43221

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Urological Research Network

    Hialeah, Florida, 33016

  • USC Institute of Urology

    Los Angeles, California, 90033

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Urology Associates

    Nashville, Tennessee, 37209

  • NYU Langone Health

    New York, New York, 10016

  • University of Pittsburgh Medical Center - Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health And Science University

    Portland, Oregon, 97239

  • Great Lakes Physician PC d/b/a Western New York Urology Associates

    Sanborn, New York, 14132

  • University of Washington

    Seattle, Washington, 98008

  • Simmons Cancer Institute

    Springfield, Illinois, 62702

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741

  • University of Kansas

    Westwood, Kansas, 66205

Other trials in United States

Japan16 sites

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519

  • Asahi General Hospital

    Chiba, 289-2511

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

  • Hitachi General Hospital

    Hitachi, 317-0077

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Nagoya University Hospital

    Nagoya, 466 8560

  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373 8550

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

  • Toranomon Hospital

    Tokyo, 105-8470

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

France15 sites

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33076

  • CHU Gabriel-Montpied

    Clermont-Ferrand, 63000

  • Hopital Huriez

    Lille, 59037

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, 75013

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020

  • Hopital Bichat Claude Bernard

    Paris, 75877

  • CHU De Poitiers

    Poitiers, 86021

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35033

  • Hopital Charles Nicolle

    Rouen, 76031

  • CHP Saint Gregoire

    Saint-Grégoire, 35760

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31000

  • Centre Hospitalier Universitaire de Nancy - Hôpital Central

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Brazil14 sites

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060

  • Oncocentro Ceará

    Fortaleza, 60135-237

  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

    Goiânia, 74605-070

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, 50070-550

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto, 14048-900

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

  • Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004

Other trials in Brazil

Italy11 sites

  • Ente Ecclesiastico Ospedale Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021

  • Ospedale Regionale Umberto Parini

    Aosta, 11100

  • Fondazione Istituto G. Giglio

    Cefalù, 90015

  • Ospedale Civile di Guastalla

    Guastalla, 42016

  • Azienda Ospedaliera ''Vito Fazzi''

    Lecce, 73100

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80138

  • UOC Oncologia Ospedale Provinciale di Macerata

    Province of Macerata, 62100

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

South Korea10 sites

  • Pusan National University Hospital

    Busan, 49241

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Germany9 sites

  • Urologicum Duisburg

    Duisburg, 47169

  • Klinikum Herne - Urologie

    Herne, 44625

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538

  • Praxisklinik Urologie Rhein/Ruhr - Germany

    Mülheim, 45468

  • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

    München, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • MVZ Urologie 24 gGmbH

    Nuremberg, 90491

  • Studienpraxis Urologie Drs. Feyerabend

    Nürtingen, 72622

  • CUROS - Uberörtliche urologische Gemeinschaftspraxis

    Wesseling, 50389

Other trials in Germany

Spain8 sites

  • Fund. Puigvert

    Barcelona, 08025

  • Hosp Clinic de Barcelona

    Barcelona, 8036

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Argentina7 sites

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    Buenos Aires, C1419AHN

  • CEMIC Saavedra

    Buenos Aires, C1431FWN

  • Hospital Britanico de Buenos Aires

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de, C1199ABB

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

  • Hospital Privado de Cordoba

    Córdoba, XX5016KEH

Other trials in Argentina

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Pratia MCM Krakow

    Krakow, 30-727

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055

  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

    Szczecin, 70-111

  • Medical Concierge Centrum Medyczne

    Warsaw, 02 798

  • City Clinic Sp. z o.o.

    Warsaw, 02-473

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50-556

Other trials in Poland

India6 sites

  • Health Care Global Enterprises pvt Ltd

    Bangalore, 560027

  • Rajiv Gandhi Cancer Institute & Research Centre

    Delhi, 110085

  • King Georges Medical University

    Lucknow, 226003

  • Meenakshi Mission Hospital and Research Center

    Madurai, 625107

  • Muljibhai Patel Urological Hospital

    Nadiād, 387001

  • CIMET s Inamdar Multispeciality Hospital

    Pune, 411040

Other trials in India

Taiwan6 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan County, 33305

Other trials in Taiwan

Australia4 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010

  • Macquarie University

    Macquarie University, 2109

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

Other trials in Australia

Belgium4 sites

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHU Sart-Tilman

    Liège, 4000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

China4 sites

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200240

  • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

Other trials in China

Czechia4 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Krajská nemocnice Liberec

    Liberec, 460 63

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

United Kingdom3 sites

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

  • Universirty of Sheffield Teaching Hospitals NHS Trust

    Sheffield, S10 2JF

  • Lister Hospital

    Stevenage, SG1 4AB

Other trials in United Kingdom

About this study

Official title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.

Read the detailed description

This study enrolls participants with high risk NMIBC and FGFR mutations or fusions. Erdafitinib is an oral pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor with demonstrated clinical activity in participants with solid tumors, including urothelial carcinoma, with alterations in the FGFR pathway. In Cohort 1, participants will be randomized to erdafitinib or to Investigators Choice (intravesical gemcitabine or intravesical mitomycin C [MMC] or hyperthermic MMC). The study consists of screening period, treatment phase, follow-up phase, and long-term extension phase.

Being tested
Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
Keywords
Non muscle invasive bladder cancer (NMIBC), Bacillus calmette- guerin (BCG) failure, BCG unresponsive
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErdafitinibDrug

    Also called JNJ-42756493

    Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.

  • Investigator Choice (Gemcitabine)Drug

    Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.

  • Investigator Choice (Mitomycin C)Drug

    Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.

Study groups in NCT04172675
Study groupRoleWhat they receive
Cohort 1: ErdafitinibExperimentalParticipants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.
Receives: Drug: Erdafitinib
Cohort 1: Investigators ChoiceActive comparatorParticipants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.
Receives: Drug: Investigator Choice (Gemcitabine); Drug: Investigator Choice (Mitomycin C)
Cohort 2ExperimentalParticipants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.
Receives: Drug: Erdafitinib
Cohort 3ExperimentalMarker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.
Receives: Drug: Erdafitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: Recurrence-Free Survival (RFS)

    RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or carcinoma in situ [CIS]), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and computed tomography (CT)/ magnetic resonance imaging (MRI) urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment. The Kaplan-Meier method was used to estimate the distribution of overall RFS for each treatment group.

    Measured: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months

Secondary outcomes (5)

  1. Cohort 1: Recurrence-Free Survival Rate at 6 Months and 12 Months

    RFS rate was the proportion of participants who were recurrence-free and alive based on Kaplan-Meier estimates. RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or CIS), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and CT/ MRI urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment.

    Measured: At Month 6 and Month 12

  2. Cohort 1: Time to Progression

    Time to progression (TTP) was defined as the time from the date of randomization until the date of first documented evidence of any of the following: disease progression (PD) or death. PD included development of or increase in stage to lamina propria invasion (for example- increase from Ta to T1), development of or increase in stage to muscle-invasive disease (stage greater than or equal to [>=] T2), development of or increase in stage to lymph node (N+) or distant metastasis (M1) disease (participants must have previously been diagnosed with N0 and/or M0 disease), increase in tumor grade from low to high (including CIS).

    Measured: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months

  3. Cohort 1: Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of the participant's death due to any cause.

    Measured: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months

  4. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were the events between first dose of study drug and up to 30 (+7 days) days after last dose or before start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure (OM).

    Measured: From start of treatment (Day 1) up to 25.2 months

  5. Plasma Concentrations of Erdafitinib

    Plasma concentrations of erdafitinib were reported. Plasma samples were analyzed using liquid chromatography/mass spectrometry method.

    Measured: All cohorts: Pre-dose on Cycle 1 Day 14, pre-dose and 3 hours post-dose on Cycle 2 Day 1 (each cycle was of 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start28 Feb 2020
  3. Primary completion12 Jul 2024
  4. Study completion27 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172675
Sponsor's protocol ID
CR108699
Other IDs
42756493BLC2003, 2019-002449-39, 2023-510306-40-00, 2023, 2019
Status last verified
Feb 2026
First submitted
20 Nov 2019
Last updated
24 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.

    PubMed 34125951

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erdafitinib, Investigator Choice (Gemcitabine) and Investigator Choice (Mitomycin C) in people with Urinary Bladder Neoplasms, run by Janssen Research & Development, LLC at 150 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Japan, France, Brazil, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Recurrence-Free Survival (RFS) (time frame: From randomization (Cycle 1 Day 1, pre-dose) up to 48.2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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