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Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC

NCT03952325 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2021-07-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tesetaxel

Tesetaxel at 27 mg/m2 orally Q3W

DRUG

Tesetaxel

Tesetaxel at 27 mg/m2 orally Q3W

DRUG

Tesetaxel

Tesetaxel at 27 mg/m2 orally Q3W

DRUG

Nivolumab

Nivolumab at 360 mg by intravenous infusion Q3W

DRUG

Pembrolizumab

Pembrolizumab at 200 mg by intravenous infusion Q3W

DRUG

Atezolizumab

Atezolizumab at 1,200 mg by intravenous infusion Q3W

DRUG

Tesetaxel

Tesetaxel at 27 mg/m2 orally Q3W

Sponsors & Collaborators

  • Odonate Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph O'Connell, M.D. · Odonate Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2021-06-23
Completion
2021-06-23
FDA Drug
Yes

Countries

  • United States
  • Singapore
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03952325 on ClinicalTrials.gov