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    DRUG:

    cetrelimab (JNJ-63723283)

    i
    Other names: JNJ-63723283, JNJ 63723283, JNJ63723283, WHO10757, JNJ-283, JNJ-3283, WHO 10757, JNJ 283, JNJ 3283, JNJ283, JNJ3283, WHO-10757
    Company:
    J&J, Xoma
    Drug class:
    PD1 inhibitor
    Related drugs:
    4d
    A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=126, Recruiting, Johnson & Johnson Enterprise Innovation Inc. | N=96 --> 126
    Enrollment change
    |
    cetrelimab (JNJ-63723283)
    12d
    SOGUG-NEOWIN: Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations (clinicaltrials.gov)
    P2, N=90, Recruiting, Spanish Oncology Genito-Urinary Group | Active, not recruiting --> Recruiting
    Enrollment open
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    Balversa (erdafitinib) • cetrelimab (JNJ-63723283)
    16d
    SOGUG-NEOWIN: Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Spanish Oncology Genito-Urinary Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    Balversa (erdafitinib) • cetrelimab (JNJ-63723283)
    27d
    17000139BLC2002: 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 (2023-507189-17-00)
    P1/2, N=89, Completed, Janssen - Cilag International | Active, not recruiting --> Completed
    Trial completion
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    29d
    A Study of JNJ-1761981 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=66, Not yet recruiting, Johnson & Johnson Enterprise Innovation Inc.
    New P1 trial
    |
    cetrelimab (JNJ-63723283)
    1m
    A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=300, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2027 --> May 2028 | Trial primary completion date: Jun 2026 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • pasritamig (JNJ-8343)
    2ms
    SunRISe-4: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (clinicaltrials.gov)
    P2, N=163, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2027 --> Mar 2026
    Trial completion date
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    2ms
    QUEST: A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=136, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    Zejula (niraparib) • abiraterone acetate • prednisone • cetrelimab (JNJ-63723283)
    2ms
    PolyDamas: A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=71, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Rybrevant (amivantamab-vmjw) • cetrelimab (JNJ-63723283)
    3ms
    A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=277, Recruiting, Janssen Research & Development, LLC | N=185 --> 277
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • pasritamig (JNJ-8343)
    4ms
    Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study. (PubMed, J Clin Oncol)
    First-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • FGFR (Fibroblast Growth Factor Receptor)
    |
    PD-L1 expression
    |
    Balversa (erdafitinib) • cetrelimab (JNJ-63723283)
    5ms
    C3NIRA: Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    PTEN mutation
    |
    carboplatin • Zejula (niraparib) • cabazitaxel • cetrelimab (JNJ-63723283)