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Cabozantinib · 2 trials · 3 indications
The primary endpoint is the efficacy of treatment via assessment of 6 month rPFS defined by RECIST version 1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. rPFS is defined as the duration of time from the first day of the start of study treatment to time of radiographic progression or death due to any cause, whichever occurs first.
* Protocol defined hematologic DLTs that occur during the first cycle that are attributed as possibly, probably, or definitely related to study treatment * Protocol defined non-hematologic DLTs possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the first cycle of treatment.
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | 40 mg of cabozantinib taken orally every day (days 1-28) of a 28 day cycle 480 mg of nivolumab given intravenously on the first day (day 1) of each 28 day cycle |
| Level 1: Cabozantinib+Abiraterone acetate +Nivolumab | EXPERIMENTAL | -Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be 20 mg. Participants can continue to receive treatment for up to 2 years. |
| Level 2: Cabozantinib+Abiraterone acetate +Nivolumab | EXPERIMENTAL | -Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be 40 mg. Participants can continue to receive treatment for up to 2 years. |
| Expansion: Cabozantinib+Abiraterone acetate +Nivolumab | EXPERIMENTAL | -Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be dependent on recommended dose found in first part of study. Participants can continue to receive treatment for up to 2 years. |
| Name | Type | Description |
|---|---|---|
| Cabozantinib | DRUG | 40 mg taken orally |
| Nivolumab | DRUG | 480 mg by infusion |
| Abiraterone acetate | DRUG | Commercially available |
| Prednisone | DRUG | Commercially available |
| Peripheral blood collection | PROCEDURE | Prior to start of treatment, after 8 weeks of combination therapy, with every subsequent imaging (every 12 weeks), end of treatment |
Inclusion Criteria: Subjects must meet all of the following applicable inclusion criteria to participate in this study: * Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health informatio...
Cabozantinib is an investigational small molecule being studied for Castration-resistant Prostate Cancer and Metastatic Hormone Refractory Prostate Cancer. It is a kinase inhibitor in the -tinib class, developed by Bristol-Myers Squibb Company (BMY). The drug is currently in Phase 2 clinical development for these oncology indications.
Cabozantinib is a kinase inhibitor, belonging to the -tinib class of targeted therapies. It works by inhibiting kinase enzymes involved in cancer cell growth and proliferation. This mechanism is being evaluated in the treatment of Castration-resistant Prostate Cancer and Metastatic Hormone Refractory Prostate Cancer.
Cabozantinib is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Castration-resistant Prostate Cancer and Metastatic Hormone Refractory Prostate Cancer.
Cabozantinib is currently in Phase 2 clinical development for Castration-resistant Prostate Cancer. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing Phase 2 trial is actively recruiting patients in the United States.
Cabozantinib is being studied in two clinical trials. NCT05502315 is a Phase 2 trial in Castration-resistant Prostate Cancer, currently recruiting 47 patients. NCT04477512 is a completed Phase 1 trial in Metastatic Hormone Refractory Prostate Cancer with 18 patients. Both trials are conducted in the United States.
Cabozantinib is the generic name for the drug also known as Cabometyx. It is being investigated by Bristol-Myers Squibb for Castration-resistant Prostate Cancer and Metastatic Hormone Refractory Prostate Cancer. The drug is a kinase inhibitor currently in Phase 2 clinical trials for these indications.