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PER-066-15

A RANDOMIZED OPEN-LABEL PHASE III STUDY OF SINGLE AGENT PEMBROLIZUMAB VERSUS SINGLEAGENT CHEMOTHERAPY PER PHYSICIAN?S CHOICE FOR METASTATIC TRIPLE NEGATIVE BREAST CANCER(MTNBC) ? (KEYNOTE-119)

Base di dati: WHO (Importata da 20.03.2024)
Cambiato: 8 set 2023, 01:00
Categoria di malattie:

Health conditions (Fonte di dati: WHO)

-C50 Malignant neoplasm of breast
Malignant neoplasm of breast;C50 ;Malignant neoplasm of breast

Interventions (Fonte di dati: WHO)


1. Pembrolizumab: 200 mg IV Q3W
2. Medications used as treatments of physician?s choice (TPC) will be handled according to local regulations and guidelines in participating countries. Sites may choose any ONE drug from the following:
Capecitabine
Eribulin
Gemcitabine
Vinorelbine

Inclusion/Exclusion Criteria (Fonte di dati: WHO)

Gender: Both
Maximum age: 100
Minimum age: 18
Inclusion criteria:
1 Have signed informed consent
2 Be ≥18 years of age on day of signing informed consent.
3 Have received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on the most recent therapy.
4 Have been previously treated with an anthracycline and/or taxane in the (neo)adjuvant or metastatic setting
5 Have centrally confirmed mTNBC
6 Have measurable disease based on RECIST 1.1
7 Have provided a newly obtained core or excisional biopsy from a metastatic, notpreviously irradiated, tumor lesion for central determination of triple-negative breast cancer status and PD-L1 biomarker analysis.
8 Have an ECOG performance status of 0 or 1 assessed within 10 days prior of treatment initiation.
9 Demonstrate adequate organ function
10 Female subjects of childbearing potential must have a negative serum pregnancy testwithin 72 hours prior to randomization and agree to use effective contraception. Male subjects should agree to use an adequate method of contraception starting at randomization through at least 120 days after the last dose of
pembrolizumab or TPC, according to local standard of care.

Exclusion criteria:
1Participated in a study of an investigational agent/device and has received it within 4 weeks of randomization
2 Monoclonal antibody (mAb) for direct anti-neoplastic treatment (4 weeks of randomization)
3 Chemotherapy, targeted small molecule therapy, or radiation therapy (2 weeks of randomization)
4 Not recovered from AE due to previous therapy
5 Active autoimmune disease that required systemic treatment (past 2 years)
6 Diagnosis of immunodeficiency or receiving systemic steroid or immunosuppressive therapy (7 days of randomization)
7 Additional malignancy that progressed or required reatment (last 5 years)
8 Known active brain metastases and/or carcinomatous meningitis
9 Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease.
10 Active infection requiring systemic therapy
11 History or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial
12 Known psychiatric or substance abuse disorders
13 Pregnant or breastfeeding, or expecting to conceive or father children
14 Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor
15 Known history of HIV
16 Known history of Hepatitis B or C
17 Has received a live vaccine (30 days of randomization)
18. Is or has an immediate family member who is part of site staff or sponsor

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=066-15

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=PER-066-15
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

23 mar 2016

Inserimento del primo partecipante

20 mag 2016

Stato di reclutamento

Recruiting

Titolo scientifico (Fonte di dati: WHO)

A RANDOMIZED OPEN-LABEL PHASE III STUDY OF SINGLE AGENT PEMBROLIZUMAB VERSUS SINGLEAGENT CHEMOTHERAPY PER PHYSICIAN?S CHOICE FOR METASTATIC TRIPLE NEGATIVE BREAST CANCER(MTNBC) ? (KEYNOTE-119)

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Estudio Fase III, controlado con tratamiento activo, abierto, randomizado, multicentrico, internacional, de pembrolizumab como agente unico comparado con la quimioterapia con el agente unico de eleccion del medico (TPC) para pacientes que reciben el tratamiento de segunda linea (2L) o de tercera linea (3L) para el cancer de mama triple negativo metastasico (mTNBC). Pacientes se estratificaran de acuerdo a estado de PD-L1 del tumor y antecedentes de tratamiento (neo)adyuvante previo vs. enfermedad metastasica de novo en el diagnostico inicial. Randomizaran 1:1 al tratamiento con pembrolizumab 200 mg IV Q3W agente unico o a la quimioterapia (TPC): capecitabina, eribulina, gemcitabina o vinorelbina. Para la rama TPC, limite maximo de incorporacion del 60% para cada farmaco. La administracion y la frecuencia del TPC de acuerdo con las reglamentaciones y pautas locales. Tratamiento continua hasta progresion,aparicion de EA inaceptable, enfermedad intercurrente que impida admin

Fase (Fonte di dati: WHO)

III

Contatto per informazioni (Fonte di dati: WHO)

Merck Sharp & Dohme Peru S.R.L.

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Paesi di esecuzione (Fonte di dati: WHO)

Australia, Belgium, Brazil, Colombia, Denmark, France, Germany, Ireland, Italy, Japan, Korea South, Malasya, Netherlands, New Zealand, Peru, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom, United States

Contatto per maggiori informazioni sulla sperimentazione

Contatto per informazioni generali (Fonte di dati: WHO)

Mariapia
Urgelles
Calle Andres Reyes Nro. 338, Piso 6
MERCK SHARP & DOHME PERU S.R.L
4115186
mariapia.urgelles@merck.com

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Rodolfo
Lozano
Calle Andres Reyes Nro. 338, Piso 6
MERCK SHARP & DOHME PERU S.R.L
4115-910
rodolfo.lozano@merck.com
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