A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

August 27, 2026 updated by: Janssen Research & Development, LLC

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Brest, Belarus, 224027
        • Brest Regional Oncology Dispensary
      • Grodno, Belarus, 230017
        • Grodno University Hospital
      • Homyel, Belarus, 246012
        • Gomel Regional Clinical Oncology Dispensary
      • Lesnoy, Belarus, 223040
        • State Institution N.N. Alexandrov Republican Scientific and
      • Minsk, Belarus, 220013
        • Minsk city Clinical Oncological Dispensary
      • Mogilev, Belarus, 212018
        • Mogilev Regional Hospital
      • Vitebsk, Belarus, 210603
        • Vitebsk Regional Clinical Hospital
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Brussels, Belgium, 1070
        • ULB Hôpital Erasme
      • Haine-Saint-Paul, Belgium, 7100
        • Jolimont
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Liège, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas - Campus Sint-Niklaas Moerland
      • Wilrijk, Belgium, 2610
        • GZA Ziekenhuizen- Campus St Augustinus
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundação Pio XII
      • Belo Horizonte, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte
      • Curitiba, Brazil, 81520 060
        • Liga Paranaense de Combate ao Cancer
      • Fortaleza, Brazil, 60170-170
        • Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro
      • Rio de Janeiro, Brazil, 22250 905
        • Oncoclinicas Rio de Janeiro S A
      • Rio de Janeiro, Brazil, 22775 001
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Santo André, Brazil, 09060-650
        • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • France
      • Angers, France, 49055
        • Institut de Cancerologie de Ouest (ICO) Site Paul Papin
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Caen, France, 14000
        • Centre Francois Baclesse
      • La Rochelle, France, 17019
        • Centre Hospitalier Saint Louis
      • Lyon, France, 69008
        • Centre Leon Berard
      • Marseille, France, 13005
        • APHM Hopital Timone
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
      • Tours, France, 37044
        • CHRU de Tours
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de cancerologie de Lorraine
      • Villejuif, France, 94800
        • Institut Gustave Roussy
  • Italy
      • Bergamo, Italy, 24125
        • Cliniche Humanitas Gavazzeni
      • Candiolo, Italy, 10060
        • Istituto di Candiolo, IRCCS
      • Carpi, Italy, 41012
        • Ospedale Di Zona B Ramazzini
      • Catania, Italy, 95126
        • UOS Oncologia Medica, A.O. Cannizzaro
      • Ferrara, Italy, 44124
        • Arcispedale S. Anna Ferrara
      • Lecco, Italy, 23900
        • PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
      • Livorno, Italy, 57122
        • Ospedale Civile Di Livorno
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Perugia, Italy, 06132
        • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
      • Piacenza, Italy, 29121
        • AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto
      • Roma, Italy, 00128
        • Campus Bio Medico di Roma
      • Sondrio, Italy, 23100
        • Azienda Socio Sanitaria Territoriale (ASST) della Valtellin
      • Terni, Italy, 05100
        • Azienda Ospedaliera S. Maria Terni
      • Udine, Italy, 33100
        • Azienda Ospedaliero Universitaria S.Maria Della Misericordia
  • Poland
      • Konin, Poland, 62-500
        • Przychodnia Lekarska KOMED Roman Karaszewski
      • Lodz, Poland, 93 513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
      • Warsaw, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie
      • Warsaw, Poland, 01-748
        • LUX MED Onkologia Sp. z o.o.
  • Russia
      • Barnaul, Russia, 656049
        • Altai Regional Oncology Dispensary
      • Ivanovo, Russia, 153040
        • Ivanovo Regional Oncology Dispensary
      • Kislino Village, Russia, 305524
        • GUZ Kursk Regional Oncology Dispensary
      • Kuzmolovsky, Russia, 188663
        • Leningrad Regional Oncology Dispensary
      • Moscow, Russia, 105077
        • City Clinical Hospital n.a. D.D.Pletnev
      • Moscow, Russia, 117997
        • Russian Scientific Center of Roentgenoradiology
      • Moscow, Russia, 125130
        • Moscow City Clinical Hospital # 62
      • Nizhny Novgorod, Russia, 603000
        • Clinical Diagnostic Centre of Nizhny Novgorod Region
      • Nizhny Novgorod, Russia, 603074
        • Privolzhsky District Medical Centre
      • Omsk, Russia, 644013
        • Clinical Oncology Dispensary
      • Pyatigorsk, Russia, 357500
        • LLC Novaya Clinica
      • Saint Petersburg, Russia, 196603
        • Private Medical Institution Euromedservice
      • Saint Petersburg, Russia, 197758
        • Russian Scientific Center of Radiology and Surgical Technologies
      • Tambov, Russia, 392013
        • Tambov Regional Oncology Clinical Dispansary
      • Tyumen, Russia, 625041
        • Multifunctional clinical medical center 'Medical city'
  • South Korea
      • Daejeon, South Korea, 35015
        • Chungnam National University Hospital
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital
      • Gyeonggi-do, South Korea, 16247
        • The Catholic University Of Korea, St. Vincent's Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, South Korea, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
      • Yangsan, South Korea, 50612
        • Pusan National University Yangsan Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hosp. Del Mar
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Madrid, Spain, 28040
        • Hosp. Clinico San Carlos
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28050
        • Hosp Univ Fund Jimenez Diaz
      • Madrid, Spain, 28050
        • Hosp Univ Hm Sanchinarro
      • Málaga, Spain, 29010
        • Hosp Virgen de La Victoria
      • Ourense, Spain, 32005
        • Complexo Hosp. Univ. de Ourense
      • Pontevedra, Spain, 36204
        • Complejo Hospitalario de Vigo
      • Pozuelo de Alarcón, Spain, 28223
        • Hosp. Quiron Madrid Pozuelo
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • H. Clinico Universitario de Santiago de Compostela
      • Seville, Spain, 41013
        • Hosp. Virgen Del Rocio
      • Seville, Spain, 41009
        • Hosp. Virgen Macarena
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
      • Valencia, Spain, 46010
        • Hosp. Clinico Univ. de Valencia
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang-Gung Memorial Hospital, LinKou Branch
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 1130
        • Adana Acibadem Hospital
      • Ankara, Turkey (Türkiye), 06520
        • Memorial Ankara Hastanesi
      • Ankara, Turkey (Türkiye), 6100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey (Türkiye), 6200
        • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Aydin, Turkey (Türkiye), 09100
        • Adnan Menderes University Training and Research Hospital
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34096
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey (Türkiye), 34732
        • Istanbul Medeniyet University Goztepe Training and Research Hospital
      • Izmir, Turkey (Türkiye), 35100
        • Ege University
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli University Medical Faculty
      • Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan University Meram Medical Faculty
      • Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Teknik University Medical Faculty
  • United Kingdom
      • Lancaster, United Kingdom, LA1 4rp
        • Royal Lancaster Infirmary
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, PA
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College - NY Presbyterian Hospital
      • White Plains, New York, United States, 10601
        • White Plains Hospital Center for Cancer Care
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute, Carolinas HealthCare System
    • Ohio
      • Toledo, Ohio, United States, 43623-3536
        • Toledo Clinic Cancer Centers
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Cancer Institute
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A.
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
  • Metastatic or locally advanced urothelial cancer
  • Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
  • Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (>) 30 milliliter per minute (mL/min) to receive carboplatin and >60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2

Exclusion Criteria:

  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
  • Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given >12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
  • Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed
  • Active malignancies requiring concurrent therapy other than urothelial cancer
  • Symptomatic central nervous system metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1b: Dose Escalation
Two dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Drug: Erdafitinib
Participants will receive erdafitinib orally.
Other Names:
  • JNJ-42756493
Drug: Cetrelimab
Participants will receive cetrelimab by intravenous infusion.
Other Names:
  • JNJ-63723283
Drug: Cisplatin
Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
Drug: Carboplatin
Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.
Experimental: Phase 2: Dose Expansion
The participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).
Drug: Erdafitinib
Participants will receive erdafitinib orally.
Other Names:
  • JNJ-42756493
Drug: Cetrelimab
Participants will receive cetrelimab by intravenous infusion.
Other Names:
  • JNJ-63723283

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Time Frame: Up to 8 weeks
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Up to 8 weeks
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
Time Frame: From Day 1 up to 36 months
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
From Day 1 up to 36 months
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Time Frame: From Day 1 up to 36 months
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
From Day 1 up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 2: Number of Participants With Abnormal Laboratory Values
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 2: Duration of Response (DoR)
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 2: Time to Response (TTR)
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 2: Progression-free Survival (PFS)
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month
Phase 2: Overall Survival (OS)
Time Frame: Up to 6 years 1 month
Up to 6 years 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108445
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2017 (U.S. NIH Grant/Contract)
  • 2017-001980-19 (EudraCT Number)
  • 42756493BLC2002 (Other Identifier: Janssen Research & Development, LLC)
  • 2023-510295-31-00 (Registry Identifier: EUCT number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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