Etude : CONTESSA TRIO / Cohorte 1: Triple négatif, PDL1+



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : CONTESSA TRIO / Cohorte 1: Triple négatif, PDL1+

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/04/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-negative, Locally Advanced or Metastatic Breast Cancer, and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

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).

Phase : II

Stade : Localement avancé à Métastatique

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Female or male patients aged ≥ 18 years old
- Histologically or cytologically confirmed breast cancer
- Most recent biopsy must be HER2 negative
Cohort 1 only: Most recent biopsy must be hormone receptor (HR) (estrogen receptor and progesterone receptor) negative
- Measurable disease per RECIST 1.1.
- Patients with bone-only metastatic cancer must have a measurable lytic or mixed lytic-blastic lesion
- Known metastases to the CNS are permitted but not required
- Documented (including de novo): (a) locally advanced breast cancer that is not considered curable by surgery and/or radiation; or (b) metastatic breast cancer
- Disease-free interval of at least 12 months after the completion of systemic neoadjuvant or adjuvant chemotherapy for patients previously treated with systemic chemotherapy for a tumor surgically resected with curative intent
- Cohort 1 only: For central determination of PD-L1 expression, adequate, newly obtained or archival core of excisional biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate bone marrow, hepatic, and renal function

Critères de non-inclusion : - Prior chemotherapy for locally advanced or metastatic disease
Cohort 1 only: prior treatment with pembrolizumab, nivolumab, atezolizumab, any other PD-(L)1/PD-L2 inhibitor, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor
- Current evidence or history of leptomeningeal disease
- Known human immunodeficiency virus infection, unless well controlled
- Known active hepatitis B or known active hepatitis C infection
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results
- Presence of neuropathy Grade > 1
- History of hypersensitivity to any of the Study drugs or any of their ingredients, as applicable
Cohort 1 only:
-> Chronic autoimmune disease
-> Evidence of active, non-infectious pneumonia (eg, pneumonia due to autoimmune or connective tissue disease)
-> Treatment with a live vaccine within 30 days prior to the first dose of nivolumab, pembrolizumab, or atezolizumab
-> History of active tuberculosis
-> Prior organ transplantation including allogeneic stem cell transplantation
-> Active infection requiring systemic therapy
-> Current or prior use of immunosuppressive medication within 7 days prior to Cycle 1, Day 1
-> Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy or biologic therapy, ≤ 14 days prior to Enrollment
- Major surgery ≤ 28 days prior to Enrollment
- Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03952325
Promoteur :
ODONATE PHARMACEUTICALS
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Christelle LEVY

TEC / ARC / IDE :
Sara GROSSI
s.grossi@
baclesse.unicancer.fr

Statut de l'essai : CLOS

MAJ : 16/04/2021