Drugs / Cetrelimab

Trials 18

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT07027514 Oct 2025 → Jun 2027 expected non-small cell lung carcinoma Ankyra Therapeutics, Inc Recruiting No outcome recorded
Phase 1 NCT06311578 Apr 2024 → Nov 2028 expected neoplasm Johnson & Johnson Enterprise Innovation Inc. Recruiting No outcome recorded
Phase 1 NCT05818683 Apr 2023 → Aug 2027 expected prostate carcinoma Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT05242445 Apr 2022 → May 2023 chronic hepatitis B virus infection Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT03547037 Aug 2018 → Jul 2022 neoplasm Janssen Pharmaceutical K.K. Completed No outcome recorded
Phase 1 NCT03551782 Jun 2018 → Nov 2021 castration-resistant prostate carcinoma Janssen Research & Development, LLC Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05908734 May 2023 → Jan 2027 expected non-small cell lung carcinoma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1/2 NCT03473743 Apr 2018 → Sep 2022 overdue urothelial carcinoma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1/2 NCT02908906 Nov 2016 → Nov 2023 overdue neoplasm Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 26 trials
Phase 2 NCT06511648 Mar 2023 → Jul 2026 overdue infiltrating bladder urothelial carcinoma Spanish Oncology Genito-Urinary Group Recruiting No outcome recorded
Phase 2 NCT04919512 Jul 2022 → Feb 2025 urinary bladder neoplasm Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT04926181 Mar 2022 → Mar 2024 prostate cancer, small cell carcinoma Rahul Aggarwal Terminated No outcome recorded Stop: Business
Phase 2 NCT04592237 Dec 2020 → Dec 2027 expected castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate small cell carcinoma M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04640623 Dec 2020 → Jul 2025 overdue urinary bladder neoplasm Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 2 NCT03431350 Mar 2018 → Aug 2021 overdue castration-resistant prostate carcinoma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03357952 Nov 2017 → Oct 2018 plasma cell myeloma Janssen Research & Development, LLC Completed No outcome recorded
Phase 32 trials
Phase 3 NCT05714202 Mar 2023 → Sep 2029 expected urinary bladder cancer Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 3 NCT04658862 Dec 2020 → Dec 2026 expected urinary bladder neoplasm Janssen Research & Development, LLC Active not recruiting No outcome recorded
Comparator or background therapy3 trials
Phase 1 NCT07525141 Background May 2026 → Jan 2028 expected neoplasm Johnson & Johnson Enterprise Innovation Inc. Recruiting No outcome recorded
Phase 1 NCT06116786 Background Nov 2023 → Apr 2027 expected non-small cell lung carcinoma Johnson & Johnson Enterprise Innovation Inc. Active not recruiting No outcome recorded
Phase 2 NCT06534190 Background Mar 2025 → Nov 2028 expected — University Medical Center Groningen Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 10

DateIssuerRelease
2025-10-20 Janssen Research & Development, LLC Results Johnson & Johnson’s INLEXZO™ (gemcitabine intravesical system) plus cetrelimab delivers strong pre-surgical results in patients with muscle invasive bladder cancer scheduled for radical cystectomy jnj.com ↗
These early results support the potential role of neoadjuvant combination therapy in future muscle invasive trials.
2024-09-16 Janssen Research & Development, LLC Results Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer jnj.com ↗
2024-09-16 Janssen Research & Development, LLC Results Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer jnj.com ↗
Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer
2024-09-15 Janssen Research & Development, LLC Results New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer jnj.com ↗
2023-06-05 Janssen Research & Development, LLC Results Janssen Announces BALVERSA® (erdafitinib) Improved Overall Survival Versus Chemotherapy in Patients with Metastatic or Unresectable Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations After Prior Anti-PD-(L)1 Treatment jnj.com ↗
2023-06-05 Janssen Research & Development, LLC Results Janssen Announces BALVERSA® (erdafitinib) Improved Overall Survival Versus Chemotherapy in Patients with Metastatic or Unresectable Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations After Prior AntiPD-(L)1 Treatmen jnj.com ↗
2023-04-30 Janssen Research & Development, LLC Results Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer jnj.com ↗
The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR).
2023-04-30 Janssen Research & Development, LLC Results Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and AntiPD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer jnj.com ↗
2021-09-17 Janssen Research & Development, LLC Results Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor jnj.com ↗
Preliminary findings suggest robust clinical activity and depth of response in patients treated with BALVERSA®in combination with cetrelimab.
2021-09-17 Janssen Research & Development, LLC Results Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor jnj.com ↗
Preliminary findings suggest robust clinical activity and depth of response in patients treated with BALVERSA® in combination with cetrelimab.

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as Cetrelimab ClinicalTrials.gov intervention name — accepted as the source's own label NCT05714202 ↗
17

NCT06116786 ↗

NCT06311578 ↗

NCT04640623 ↗

NCT05242445 ↗

NCT04926181 ↗

NCT06534190 ↗

NCT07525141 ↗

NCT04919512 ↗

NCT05818683 ↗

NCT03473743 ↗

Show 7 more sources

Known as CET “Cetrelimab (CET) combination” NCT06511648 ↗
Known as JNJ-63723283 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03547037 ↗
2

NCT02908906 ↗

NCT03357952 ↗

Action Inhibit “monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283)” PMID 42313189 ↗ Jun 2026
1

“Programmed cell death protein 1 inhibitor” CHEMBL4298001 ↗

Modality Monoclonal antibody “JNJ-63723283, an Anti-PD-1 Monoclonal Antibody” NCT02908906 ↗
Route Intravenous “JNJ-63723283 will be administered by IV infusion or SC injection or infusion.” NCT02908906 ↗
Route Subcutaneous “JNJ-63723283 will be administered by IV infusion or SC injection or infusion.” NCT02908906 ↗
Target PDCD1 “Programmed cell death protein 1 inhibitor” CHEMBL4298001 ↗