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    DRUG:

    cetrelimab (JNJ-63723283)

    i
    Other names: JNJ-63723283, JNJ 63723283, JNJ63723283, JNJ-283, JNJ-3283, WHO 10757, JNJ 283, JNJ 3283, JNJ283, JNJ3283, WHO-10757, WHO10757
    Company:
    J&J, Xoma
    Drug class:
    PD1 inhibitor
    Related drugs:
    22d
    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)
    1m
    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)
    2ms
    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 | Trial completion date: Mar 2029 --> Oct 2029 | Trial primary completion date: Mar 2026 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    Balversa (erdafitinib) • cetrelimab (JNJ-63723283)
    2ms
    SunRISe-1: 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 (clinicaltrials.gov)
    P2, N=220, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jul 2027 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    3ms
    Therapeutic Intensification Based on Immune Checkpoint Inhibitors in Non-Muscle Invasive Bladder Cancer: State of the Art and Future Perspectives. (PubMed, Cancers (Basel))
    Therapeutic intensification using systemic immunotherapy applies to both BCG-unresponsive NMIBC, with a new target pathway (HLA-E/NKG2A), and BCG-naïve HR NMIBC, where the combination of BCG instillations and immunotherapy represents a major breakthrough.
    Review • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    HLA-E (Major Histocompatibility Complex, Class I, E) • KLRC1 (Killer Cell Lectin Like Receptor C1)
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • sasanlimab (PF-06801591) • cetrelimab (JNJ-63723283)
    4ms
    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 completion date: Sep 2026 --> Mar 2027
    Trial completion date
    |
    EGFR L858R • EGFR exon 19 deletion
    |
    Rybrevant (amivantamab-vmjw) • cetrelimab (JNJ-63723283)
    4ms
    ANK-101-004: 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 (clinicaltrials.gov)
    P1, N=60, Recruiting, Ankyra Therapeutics, Inc | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cetrelimab (JNJ-63723283)
    5ms
    A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=96, Recruiting, Johnson & Johnson Enterprise Innovation Inc. | Trial completion date: Nov 2033 --> Aug 2032
    Trial completion date
    |
    cetrelimab (JNJ-63723283)
    5ms
    A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers (clinicaltrials.gov)
    P1/2, N=413, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2025 --> Dec 2026
    Trial completion date • First-in-human
    |
    cetrelimab (JNJ-63723283)
    5ms
    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=245, Recruiting, Janssen Research & Development, LLC | N=176 --> 245
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • pasritamig (JNJ-8343)
    5ms
    NORSE: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (clinicaltrials.gov)
    P1/2, N=125, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2025 --> Oct 2026
    Trial completion date
    |
    cisplatin • carboplatin • Balversa (erdafitinib) • cetrelimab (JNJ-63723283)
    6ms
    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 | Phase classification: P1/2 --> P2
    Phase classification
    |
    Zejula (niraparib) • abiraterone acetate • prednisone • cetrelimab (JNJ-63723283)