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Pembrolizumab · 1 trial · 4 indications
Compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone. PFS is defined as the time from study randomization to disease progression, according to RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first. Patients alive without disease progression are censored at the date of last disease evaluation.
| Arm | Type | Description |
|---|---|---|
| Sacituzumab Govitecan + Pembrolizumab | EXPERIMENTAL | The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle |
| Sacituzumab Govitecan | EXPERIMENTAL | The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle |
| Retreatment | EXPERIMENTAL | Participants who have attained a confirmed complete response (CR) who have been treated for at least 24 weeks on protocol therapy and had at least three cycles (with pembrolizumab and sacituzumab govitecan (Arm A) or sacituzumab govitecan alone (Arm B)) beyond the date when the initial CR was declared may be eligible for additional sacituzumab govitecan and/or pembrolizumab therapy if they progress after stopping study treatment. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the subject meets protocol-specified conditions. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | (iv) fixed dose, administered once per cycle |
| Sacituzumab Govitecan | DRUG | (iv) fixed dose, administered twice per cycle |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from...
Pembrolizumab is being studied in a Phase 2 clinical trial for the treatment of Invasive Breast Cancer, specifically in patients with HR-positive, HER2-negative metastatic breast cancer. The trial evaluates pembrolizumab in combination with sacituzumab govitecan compared to sacituzumab govitecan alone. The study is active but not recruiting participants.
Pembrolizumab targets PDCD1, also known as programmed cell death protein 1, and acts as an inhibitor of this target. By inhibiting PDCD1, pembrolizumab is designed to modulate the immune system's response to cancer cells. This mechanism is being investigated in the context of invasive breast cancer in an ongoing Phase 2 clinical trial.
Pembrolizumab is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is being investigated in a Phase 2 clinical trial for invasive breast cancer, with the trial sponsored by the developer.
Pembrolizumab is in Phase 2 clinical development for the treatment of Invasive Breast Cancer. It is an investigational drug in this indication and has not been approved for this use. The ongoing Phase 2 trial is active but not recruiting, with an enrollment of 110 participants.
Pembrolizumab is involved in one active clinical trial with the identifier NCT04448886. This Phase 2 trial, titled 'Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC', is investigating pembrolizumab in combination with sacituzumab govitecan for HR-positive, HER2-negative metastatic breast cancer. The trial is being conducted in the United States and enrolls adults aged 18 years and older.
Yes, Pembrolizumab is the same as KEYTRUDA, which is a brand name for the drug. The alternative name for pembrolizumab is 'Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]'. In clinical trials, the drug is referred to as pembrolizumab, and it is being studied for use in invasive breast cancer.