Resumen

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Confirmed squamous cell head and neck cancer
Widespread (metastatic) disease, or returned after previous treatment (recurrent)
Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV \[Human Papilloma Virus (oropharynx only)\]
Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Criterios de exclusión

Previous treatment for metastatic or recurrent disease
Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
Any non-squamous subtype
Active autoimmune disease
Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
Previous treatment with checkpoint inhibitor drugs
Active CNS metastases or carcinomatous meningitis

Intervenciones

biological

Nivolumab

biological

Ipilimumab

other

Placebo

Ubicaciones

Local Institution - 0121

Pergamino, Buenos Aires, Argentina

Local Institution - 0111

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)