Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Patients With HER2 Negative MBC (CONTESSA TRIO)

Official Title

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

Summary:

CONTESSA TRIO is a 2-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane. In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) 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 dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with HER2 negative locally advanced or metastatic breast cancer (MBC) who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary endpoint for Cohort 2 is ORR.

Trial Description

CONTESSA TRIO is a 2-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane.

Cohort 1:

Approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic TNBC 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 (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. Patients with central nervous system (CNS) metastases are eligible. The dual primary endpoints for Cohort 1 are ORR and PFS. Secondary endpoints include duration of response (DoR) and overall survival (OS).

Cohort 2:

Approximately 40 elderly patients (with potential expansion to up to 60 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. Patients with CNS metastases are eligible. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society