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    DRUG:

    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

    i
    Other names: 177 Lu PSMA-617, Lu177-PSMA-617, Lu177 RLT, 177LU-PSMA-617, PSMA-617, 177lutetium-PSMA-617, AAA617, AAA-617, AAA 617
    Company:
    Novartis, Otsuka
    Drug class:
    Beta radiation emitter, PSMA inhibitor
    Related drugs:
    1d
    Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov)
    P2, N=87, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    4d
    Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (clinicaltrials.gov)
    P2, N=40, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    5d
    NEPI: Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer (clinicaltrials.gov)
    P1/2, N=1, Terminated, University Hospital, Essen | Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    Yervoy (ipilimumab) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    6d
    NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> Aug 2026 | Trial primary completion date: Jun 2027 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • SSTR2 (Somatostatin Receptor 2) • SYP (Synaptophysin) • CHGA (Chromogranin A)
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
    6d
    CA184-608: Neoadjuvant Lu-PSMA radioligand therapy and Ipilimumab in men with very high-risk prostate cancer (NEPI) (2024-514386-19-00)
    P1, N=12, Completed, Universitaetsklinikum Essen AR | Suspended --> Completed
    Trial completion
    |
    Yervoy (ipilimumab) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    10d
    CAMO959A12103: A clinical trial to learn about the effects of AMO959 given with AAA617 and an androgen receptor pathway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body.athway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body. (2025-521859-23-00)
    P1/2, N=61, Not yet recruiting, Novartis Pharma AG
    New P1/2 trial
    |
    Xtandi (enzalutamide) • abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Firmagon (degarelix) • Orgovyx (relugolix)
    12d
    Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN) (clinicaltrials.gov)
    P=N/A, N=170, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Real-world evidence
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    13d
    A Study of Patient Characteristics, Treatment Patterns and Outcomes Among Patients Treated With 177Lu-PSMA-617 (clinicaltrials.gov)
    P=N/A, N=6448, Completed, Novartis Pharmaceuticals
    New trial
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    14d
    STAMPEDE2: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P3, N=296, Recruiting, University College, London | N=76 --> 296
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    14d
    PSMACare: A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (clinicaltrials.gov)
    P2, N=49, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2030 --> Dec 2026 | Trial primary completion date: Apr 2028 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    FOLH1 positive
    |
    Xtandi (enzalutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    18d
    Lu-177 PSMA Treatment in Cell Renal Carcinoma (clinicaltrials.gov)
    P3, N=20, Not yet recruiting, Ankara University | Initiation date: Aug 2025 --> May 2026
    Trial initiation date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    18d
    Bullseye: Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov)
    P2, N=58, Completed, Radboud University Medical Center | Active, not recruiting --> Completed
    Trial completion
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan)