CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC. Cohort 1: Approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 once every three weeks (Q3W) plus either: * Nivolumab at 360 mg by intravenous infusion Q3W; * Pembrolizumab at 200 mg by intravenous infusion Q3W; or * Atezolizumab at 1,200 mg by intravenous infusion Q3W. Nivolumab and pembrolizumab (programmed cell death protein 1 \[PD-1\] inhibitors) and atezolizumab (a programmed death-ligand 1 \[PD-L1\] inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. Two of these agents, atezolizumab and pembrolizumab, have been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with triple-negative MBC. The primary efficacy endpoints for Cohort 1 are ORR and PFS in patients with PD-L1 positive status. The secondary efficacy endpoints are ORR and PFS in all patients, duration of response (DoR) and overall survival (OS). Cohort 2: Approximately 60 elderly patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 Q3W. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with HR-positive, HER2-negative disease. The secondary efficacy endpoints are ORR and PFS in patients with triple-negative disease, DoR and OS. Cohort 3: Approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 Q3W. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease. The secondary efficacy endpoints are ORR and PFS in patients with triple negative disease, DoR and OS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
Tesetaxel at 27 mg/m2 orally Q3W
Tesetaxel at 27 mg/m2 orally Q3W
Tesetaxel at 27 mg/m2 orally Q3W
Nivolumab at 360 mg by intravenous infusion Q3W
Pembrolizumab at 200 mg by intravenous infusion Q3W
Atezolizumab at 1,200 mg by intravenous infusion Q3W
Tesetaxel at 27 mg/m2 orally Q3W
Sarah Cannon Research Institute - Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, United States
Florida Cancer Specialists and Research Institute - Panhandle Region
Tallahassee, Florida, United States
Florida Cancer Specialists and Research Institute
West Palm Beach, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
New York Cancer and Blood Specialists
East Setauket, New York, United States
West Cancer Center
Germantown, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
John Hopkins Singapore International Medical Centre
Singapore, Singapore
...and 2 more locations
Cohort 1: ORR in patients with PD-L1 positive status
Time frame: Approximately 2.0-3.0 years
Cohort 1: PFS in patients with PD-L1 positive status
Time frame: Approximately 2.5-3.5 years
Cohort 2: ORR in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 2: PFS in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 3: ORR in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 3: PFS in patients with HR-positive, HER2-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 1: ORR in all patients
Time frame: Approximately 2.0-3.0 years
Cohort 1: PFS in all patients
Time frame: Approximately 2.0-3.0 years
Cohort 1: DoR
Time frame: Approximately 2.5-3.5 years
Cohort 1: OS
Time frame: Approximately 4.0-5.0 years
Cohort 2: ORR in patients with triple-negative disease
Time frame: Approximately 2.0-3.0 years
Cohort 2: PFS in patients with triple-negative disease
Time frame: Approximately 2.5-3.5 years
Cohort 2: DoR
Time frame: Approximately 2.5-3.5 years
Cohort 2: OS
Time frame: Approximately 4.0-5.0 years
Cohort 3: ORR in patients with triple-negative disease
Time frame: Approximately 1.0-2.0 years
Cohort 3: PFS in patients with triple-negative disease
Time frame: Approximately 1.5-2.5 years
Cohort 3: DoR
Time frame: Approximately 2.5-3.5 years
Cohort 3: OS
Time frame: Approximately 4.0-5.0 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.