Approval Probability
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Trilaciclib · 1 trial · 1 indication
Objective according to RECIST v1.1 criteria
| Arm | Type | Description |
|---|---|---|
| Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin | EXPERIMENTAL | Trilaciclib is an agent that helps protect the bone marrow from the side effects of chemotherapy. It is given as an intravenous (IV) infusion over 30 minutes prior to gemcitabine and carboplatin. Gemcitabine is given IV over 30 minutes. Carboplatin is given over 30 minutes. Trilaciclib, gemcitabine and carboplatin are given on Days 1 and 8 every 21 days. Pembrolizumab is given IV over 30 minutes on Day 1 every 21 days. |
| Name | Type | Description |
|---|---|---|
| Trilaciclib | DRUG | IV infusion Day 1 and Day 8 every 21 days, at dose of 240 mg/m2 |
| Pembrolizumab | DRUG | IV infusion Day 1 every 21 days, at dose of 200 mg |
| Gemcitabine | DRUG | IV infusion Day 1 and Day 8 every 21 days, at dose 1000 mg/m2 |
| Carboplatin | DRUG | IV infusion Day 1 and Day 8 every 21 days, at dose area under curve (AUC) 2 (maximum of 300 mg) |
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information signed by the patient 2. Male or female with locally advanced unresectable or metastatic TNBC 3. Age ≥ 18 years at the time of consent 4. Eastern Cooperative Oncology Group (ECOG) Perf...
Trilaciclib is being studied for the treatment of metastatic triple-negative breast cancer. It is an investigational small molecule being evaluated in combination with pembrolizumab, gemcitabine, and carboplatin in a Phase 2 clinical trial. The drug is not yet approved and remains in clinical development.
Trilaciclib targets cyclin-dependent kinases (CDKs), as it belongs to the -ciclib class of CDK inhibitors. By inhibiting CDKs, the drug is designed to modulate cell cycle progression. This mechanism is being explored in the context of metastatic triple-negative breast cancer treatment.
Trilaciclib is being developed by Merck & Company, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate the drug's safety and efficacy in metastatic triple-negative breast cancer.
Trilaciclib is currently in Phase 2 clinical development. It is being investigated as a treatment for metastatic triple-negative breast cancer. The drug is investigational and has not been approved by regulatory authorities. One active Phase 2 trial is ongoing, with enrollment completed.
Trilaciclib is being studied in a Phase 2 trial with the identifier NCT06027268. The trial is titled 'Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer.' It is active but not recruiting, with a planned enrollment of 36 participants in the United States.
Trilaciclib is also known by the brand name Cosela. The drug is being developed by Merck & Company, Inc. under the ticker MRK. In the context of metastatic triple-negative breast cancer, it is being evaluated in a Phase 2 clinical trial.