Cetrelimab

Phase 3Monoclonal antibody

Johnson & Johnson

Cetrelimab is one of 208 small molecule programs targeting Urinary Bladder Neoplasms. It is currently in Phase 3.

Indications

Total Trials

Active Trials

207

Competitors

Pipeline

Status by Indication[3][1]

Indication

Urinary Bladder NeoplasmsActive, not recruiting

Bladder CancerActive, not recruiting

Metastatic Castration-Resistant Prostate NeoplasmsRecruiting

NeoplasmsRecruiting

Prostatic Neoplasms, Castration-ResistantActive, not recruiting

Solid TumoursRecruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Non-Small Cell Lung CancerRecruiting

Urothelial CarcinomaActive, not recruiting

Urinary Bladder NeoplasmsPhase 3

Active, not recruiting

Bladder CancerPhase 3

Active, not recruiting

Metastatic Castration-Resistant Prostate NeoplasmsPhase 1

Recruiting

NeoplasmsPhase 1

Recruiting

Prostatic Neoplasms, Castration-ResistantPhase 2

Active, not recruiting

Solid TumoursPhase 2

Recruiting

Carcinoma, Non-Small-Cell LungPhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Recruiting

Urothelial CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Albumin-Bound Paclitaxel

Bristol-Myers Squibb

Phase 3

2 2

KN046

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

Phase 3

4 3

Cetrelimab

Johnson & Johnson

Phase 3

1 4

TAK-788

Takeda

Phase 3

4 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Treatment

GSK

Preclinical

1 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—10

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalActive, not recruiting

Urothelial Carcinoma

NCT03473743

Phase 2Active, not recruiting

Prostatic Neoplasms, Castration-Resistant

NCT03431350

Q1 2027

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05908734

Q3 2027

Phase 2Active, not recruiting

Urinary Bladder Neoplasms

NCT04640623

Q4 2027

Phase 2Active, not recruiting

Aggressive Variant Prostate Carcinoma

NCT04592237

Clinical

Trials by Indication[1]

Urinary Bladder Neoplasms3 trials

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04640623·220 enrolled

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04658862·518 enrolled

A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04919512·163 enrolled

Prostate Cancer2 trials

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

Terminated·RRahul Aggarwal·Phase 2·NCT04926181·2 enrolled

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03551782·33 enrolled

Carcinoma, Non-Small-Cell Lung2 trials

A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-Small Cell Lung Cancer

Active, not recruiting·JJohnson & Johnson Enterprise Innovation Inc.·Phase 1·NCT06116786·67 enrolled

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05908734·71 enrolled

Neoplasms2 trials

Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors

Recruiting·JJohnson & Johnson Enterprise Innovation Inc.·Phase 1·NCT07525141·66 enrolled

Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors

Recruiting·JJohnson & Johnson Enterprise Innovation Inc.·Phase 1·NCT06311578·126 enrolled

Solid Tumours1 trial

CD8 PET Imaging in Metastatic Solid Tumours

Recruiting·UUniversity Medical Center Groningen·Phase 2·NCT06534190·30 enrolled

7 more indications

Chronic Hepatitis B Virus Infection1 trial

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05242445·11 enrolled

Aggressive Variant Prostate Carcinoma1 trial

Randomized Phase II Study of Platinum-Taxane-Cetrelimab Induction Followed by Niraparib Plus or Minus Cetrelimab Maintenance in Men With Aggressive Variant Prostate Cancers

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04592237·120 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase 1b, Two-Part 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

Recruiting·AAnkyra Therapeutics, Inc·Phase 1·NCT07027514·60 enrolled

Bladder Cancer1 trial

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety 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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05714202·1,135 enrolled

Urothelial Carcinoma1 trial

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT03473743·125 enrolled

Metastatic Castration-resistant Prostate Neoplasms1 trial

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05818683·300 enrolled

Prostatic Neoplasms, Castration-Resistant1 trial

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03431350·136 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Cetrelimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cetrelimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cetrelimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

Cetrelimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Urinary Bladder Neoplasms3 trials

Prostate Cancer2 trials

Carcinoma, Non-Small-Cell Lung2 trials

Neoplasms2 trials

Solid Tumours1 trial

Chronic Hepatitis B Virus Infection1 trial

Aggressive Variant Prostate Carcinoma1 trial

Non-Small Cell Lung Cancer1 trial

Bladder Cancer1 trial

Urothelial Carcinoma1 trial

Metastatic Castration-resistant Prostate Neoplasms1 trial

Prostatic Neoplasms, Castration-Resistant1 trial

References

Drug Info

Quick Facts

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