Cetrelimab

DRUG15 trials

Sponsors

Janssen - Cilag International, Janssen Research & Development, LLC, M.D. Anderson Cancer Center, Rahul Aggarwal, Johnson & Johnson Enterprise Innovation Inc.

Conditions

Advanced Stage Solid TumorsAggressive Variant Prostate CarcinomaBladder CancerCarcinoma, Non-Small-Cell LungCarcinoma, Non-small-Cell LungCastration-Resistant Prostate CarcinomaHepatitis B, ChronicLocally Advanced Solid Tumor

Phase 1

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

Active, not recruitingNCT03473743

Janssen Research & Development, LLCUrothelial Carcinoma

Start: 2018-04-05End: 2026-12-31Updated: 2026-03-30

A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection

CompletedNCT05242445

Janssen Research & Development, LLCHepatitis B, Chronic

Start: 2022-04-19End: 2023-05-09Updated: 2023-07-24

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

RecruitingNCT05818683

Janssen Research & Development, LLCMetastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer

Start: 2023-04-26End: 2028-05-23Target: 300Updated: 2026-04-01

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

Active, not recruitingNCT05908734

Janssen Research & Development, LLCCarcinoma, Non-Small-Cell Lung

Start: 2023-05-18End: 2027-03-31Updated: 2026-03-13

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer

RecruitingNCT06116786

Johnson & Johnson Enterprise Innovation Inc.Carcinoma, Non-small-Cell Lung

Start: 2023-11-27End: 2029-06-07Target: 126Updated: 2026-03-13

A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

RecruitingNCT06311578

Johnson & Johnson Enterprise Innovation Inc.Neoplasms

Start: 2024-04-10End: 2032-08-26Target: 96Updated: 2026-02-13

A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers

Active, not recruitingCTIS2023-506144-16-00

Janssen - Cilag InternationalAdvanced Stage Solid Tumors

Start: 2016-12-06Target: 3Updated: 2025-03-16

A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer

RecruitingNCT07027514

Ankyra Therapeutics, IncNon Small Cell Lung Cancer

Start: 2025-10-22End: 2028-12-31Target: 60Updated: 2025-11-18

Phase 2

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Active, not recruitingNCT04592237

M.D. Anderson Cancer CenterAggressive Variant Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma +3

Start: 2020-12-29End: 2027-12-31Target: 120Updated: 2025-12-23

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Active, not recruitingNCT04640623

Janssen Research & Development, LLCUrinary Bladder Neoplasms

Start: 2020-12-18End: 2027-09-30Updated: 2026-03-13

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Active, not recruitingNCT04919512

Janssen Research & Development, LLCUrinary Bladder Neoplasms

Start: 2022-07-07End: 2026-03-31Updated: 2026-03-25

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer

TerminatedNCT04926181

Rahul AggarwalProstate Cancer, Small Cell Carcinoma, Small Cell Neuroendocrine Carcinoma

Start: 2022-03-16End: 2024-03-31Updated: 2025-05-15

CD8 PET Imaging in Metastatic Solid Tumours

RecruitingNCT06534190

University Medical Center GroningenLocally Advanced Solid Tumor

Start: 2025-03-11End: 2028-11-01Target: 30Updated: 2026-02-09

Phase 3

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Active, not recruitingNCT04658862

Janssen Research & Development, LLCUrinary Bladder Neoplasms

Start: 2020-12-07End: 2028-12-31Updated: 2026-03-19

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Active, not recruitingNCT05714202

Janssen Research & Development, LLCBladder Cancer

Start: 2023-03-23End: 2029-09-18Updated: 2026-03-19

Related Papers

Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results.

2025-12-031 citations

TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial.

2025-08-273 citations

The Evolving Landscape of Systemic Immunotherapy for Bacillus Calmette-Guérin-naïve High-risk Non-muscle-invasive Bladder Cancer: At the Edge of a Tsunami?

2025-08-051 citations

TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study

Journal of Clinical Oncology2025-07-3010 citations

C3NIRA: Randomized phase II study of carboplatin-cabazitaxel-cetrelimab (anti-PD-1) induction followed by niraparib +/- cetrelimab maintenance in men with aggressive variant prostate cancers (AVPC).

Journal of Clinical Oncology2025-05-281 citations

Abstract CT137: Initial results from a phase 1 study of an A2a receptor antagonist, administered as monotherapy and in combination with anti-PD1 therapy in patients with advanced non-small cell lung cancer

Cancer Research2025-04-25

Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas

BMJ Open2025-02-014 citations

P2-01 TAR-200 IN PATIENTS WITH BACILLUS CALMETTE–GUÉRIN-UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER: RESULTS FROM SUNRISE-1 STUDY

The Journal of Urology2024-05-0111 citations

The Safety, Tolerability, and Preliminary Efficacy of a Gemcitabine-releasing Intravesical System (TAR-200) in American Urological Association-defined Intermediate-risk Non-muscle-invasive Bladder Cancer Patients: A Phase 1b Study.

2024-02-1615 citations

Reasons for refusal of or ineligibility for radical cystectomy (RC) in patients (Pts) with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) from the SunRISe-1 study.

Journal of Clinical Oncology2024-01-291 citations

Erdafitinib (ERDA) vs ERDA plus cetrelimab (ERDA+CET) for patients (pts) with metastatic urothelial carcinoma (mUC) and fibroblast growth factor receptor alterations (FGFRa): Final results from the phase 2 Norse study.

Journal of Clinical Oncology2023-06-0141 citations

SunRISe-4: TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy.

Journal of Clinical Oncology2023-02-209 citations

Outcomes of Patients with Advanced Urothelial Carcinoma after Anti-programmed Death-(ligand) 1 Therapy by Fibroblast Growth Factor Receptor Gene Alteration Status: An Observational Study.

2022-12-154 citations

First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers

Cancer Chemotherapy and Pharmacology2022-03-1723 citations

SunRISe-1: Phase 2b study of TAR-200 plus cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk nonmuscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guérin who are ineligible for or decline radical cystectomy.

Journal of Clinical Oncology2022-02-1611 citations

MP13-17 SUNRISE-2: A PHASE 3, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY OF TAR-200 IN COMBINATION WITH CETRELIMAB VERSUS CONCURRENT CHEMORADIOTHERAPY IN PARTICIPANTS WITH MUSCLE-INVASIVE UROTHELIAL CARCINOMA OF THE BLADDER

The Journal of Urology2021-08-043 citations

A phase 3, multicenter, randomized study evaluating the efficacy of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive urothelial carcinoma of the bladder.

Journal of Clinical Oncology2021-05-205 citations

Evolving development of PD-1 therapy: Cetrelimab (JNJ-63723283) from monotherapy to combination with erdafitinib.

Journal of Clinical Oncology2020-05-202 citations

Does escalation results from phase Ib/II Norse study of erdafitinib (ERDA) + PD-1 inhibitor JNJ-63723283 (Cetrelimab [CET]) in patients (pts) with metastatic or locally advanced urothelial carcinoma (mUC) and selected fibroblast growth factor receptor (FGFR) gene alterations.

Journal of Clinical Oncology2020-02-1915 citations