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Lutetium Lu 177 Vipivotide Tetraxetan · 2 trials · 4 indications
PSA progression is defined as a rise in PSA at \> 12 weeks by more than 25% and more than 2ng/mL above the nadir (lowest PSA point). Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
Will be calculated as the percentage with 95% confidence interval (CI) of the total number of patients who had PSMA-high expression on re-assessment gallium Ga 68 gozetotide (68Ga)-PSMA-11 positron emission tomography (PET).
| Arm | Type | Description |
|---|---|---|
| Treatment (177Lu-PSMA-617) | EXPERIMENTAL | Patients receive 177Lu-PSMA-617 IV over 30 minutes on days 1, 8, 50, 57, 99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA-PET/CT during screening and SPECT/CT on study. Patients also undergo CT or MRI, bone scan, as well as blood sample collection throughout the study. |
| Treatment (vorinostat, 177Lu-PSMA-617) | EXPERIMENTAL | Patients receive vorinostat PO QD for 28 days and then receive gallium Ga 68 gozetotide IV and undergo a PET scan on trial. Patients may go on to receive 177Lu-PSMA-617 IV per SOC on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and bone scan on trial and during follow-up, as well as a FDG PET/CT during screening and on trial and SPECT/CT on trial. Patients undergo blood sample collection on trial and may also optionally undergo biopsy during screening and on trial. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Scan | PROCEDURE | Undergo bone scan |
| Computed Tomography | PROCEDURE | Undergo SPECT/CT and CT |
| Lutetium Lu 177 Vipivotide Tetraxetan | DRUG | Given IV |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| PSMA PET-CT Scan | PROCEDURE | Undergo PSMA PET/CT |
| Questionnaire Administration | OTHER | Ancillary studies |
| Single Photon Emission Computed Tomography | PROCEDURE | Undergo SPECT/CT |
| Biopsy Procedure | PROCEDURE | Undergo biopsy |
| Fludeoxyglucose F-18 | OTHER | Undergo FDG PET/CT |
| Gallium Ga 68 Gozetotide | OTHER | Given IV |
| Positron Emission Tomography | PROCEDURE | Undergo 68Ga-PSMA-11 PET |
| Vorinostat | DRUG | Given IV |
Inclusion Criteria: * Patients must have the ability to understand and sign an approved informed consent. * Patients must have the ability to understand and comply with all protocol requirements. * Patients must be ≥ 18 years of age. * Patients must have an Eastern Cooperative Oncology Group (ECOG)...
Lutetium Lu 177 Vipivotide Tetraxetan is used for the treatment of castration-resistant prostate carcinoma and metastatic castration-resistant prostate carcinoma. It is being studied in patients with PSMA-expressing disease, including those with low PSMA expression, as part of ongoing clinical trials.
Lutetium Lu 177 Vipivotide Tetraxetan targets prostate-specific membrane antigen (PSMA), which is expressed on prostate cancer cells. The drug is designed to deliver radiation to PSMA-positive tumors, and its use is guided by PSMA expression levels as determined by imaging biomarkers.
Lutetium Lu 177 Vipivotide Tetraxetan is developed by Novartis AG, a company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer.
Lutetium Lu 177 Vipivotide Tetraxetan is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are recruiting patients to further assess its potential as a treatment for metastatic castration-resistant prostate cancer.
Lutetium Lu 177 Vipivotide Tetraxetan is being studied in two Phase 2 trials: NCT06145633, which combines vorinostat with the drug for PSMA-low metastatic castration-resistant prostate cancer, and NCT06526299, which evaluates intensified treatment for patients with low PSMA-expressing disease. Both trials are recruiting in the United States.