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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:
    1d
    Can manual gemcitabine instillation or tumor microenvironment-based selection enhance the efficacy of TAR-200 in bladder cancer? (PubMed, Transl Oncol)
    We hypothesize that assessing baseline or BCG-induced immunosuppressive status may help identify patients who would derive greater benefit from the addition of the PD-1 inhibitor cetrelimab to TAR-200. These considerations warrant further investigation to maximize therapeutic efficacy in this challenging patient population.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    3d
    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, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion
    |
    cetrelimab (JNJ-63723283) • Inlexzo (gemcitabine intravesical system)
    8d
    A phase I study evaluating subcutaneous administration of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced solid malignancies. (PubMed, Cancer Immunol Immunother)
    RP2D of subcutaneous cetrelimab was established as a loading dose of 900 mg followed by 600 mg Q3W. Subcutaneous cetrelimab demonstrated characteristics consistent with prior characterization of intravenous cetrelimab. Trial registration NCT02908906 at ClinicalTrials.gov, September 21, 2016; EudraCT 2016-002,017-22 at clinicaltrialsregister.eu, Jan 11, 2017.
    P1 data • Journal
    |
    PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    cetrelimab (JNJ-63723283)
    18d
    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=234, Active, not recruiting, Janssen Research & Development, LLC | N=413 --> 234
    Enrollment change • First-in-human
    |
    cetrelimab (JNJ-63723283)
    1m
    A Study of JNJ-1761981 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=66, Recruiting, Johnson & Johnson Enterprise Innovation Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cetrelimab (JNJ-63723283)
    2ms
    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)
    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 | Active, not recruiting --> Recruiting
    Enrollment open
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    Balversa (erdafitinib) • 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, Active, not recruiting, Spanish Oncology Genito-Urinary Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    Balversa (erdafitinib) • cetrelimab (JNJ-63723283)
    2ms
    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)
    2ms
    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)
    3ms
    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 • enzalutamide • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • apalutamide • cetrelimab (JNJ-63723283) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • pasritamig (JNJ-8343)
    3ms
    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)