Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects W… (NCT04282109) | Clinical Trial Compass
CompletedPhase 2
Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects With Head and Neck Cancer Unable for Cisplatin-based Chemotherapy (NIVOTAX)
Spain141 participantsStarted 2020-06-03
Plain-language summary
Chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma is palliative and usually platinum based, and the patients often present with poor physical condition. Consequently, many of them are not able to withstand a platinum-based chemotherapy. The addition of taxanes to the armamentarium of drugs improve the outcome in this group of patients. An alternative and better tolerated regimen for these patients is paclitaxel in combination with cetuximab, included the in guidelines of the Spanish Society of Medical Oncology.
Recently, new treatments such as immune-checkpoint inhibitors have shown promising activity and good tolerability in patients with recurrent or metastatic head and neck squamous cell carcinoma and has been included in the recently published guidelines from the Society for Immunotherapy of Cancer. Nivolumab (anti-PD1) has been approved for patients progressing on or after platinum-based therapy, as it clearly impacts on overall survival.
This randomized phase II study will evaluate the efficacy of nivolumab plus paclitaxel for first-line treatment of recurrent or metastatic HNSCC in the platinum ineligible and platinum refractory settings. Control arm will be paclitaxel in combination with cetuximab, treatment included in the guidelines of the Spanish Society of Medical Oncology.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care.
✓. Histologically confirmed HNSCC (oral cavity, oropharynx, hypopharynx, larynx) not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
✓. Patients not previously treated for recurrent/metastatic disease.
✓. Radiographically measurable disease as defined by RECIST version 1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression according to RECIST version 1.1.
✓. Patients unable for cisplatin-based chemotherapy, defined "unable" by:
✓. Karnofsky 70% or
✓. Karnofsky 80-100% and amenable to chemotherapy, but:
✓. Male or female patients aged ≥18 years. Patients aged ≥70 years old can only be included with a G8 (Geriatric 8) health status screening score ≥ 14.
Exclusion criteria
What they're measuring
1
Two Years Overall Survival (OS)
Timeframe: 2 years
Trial details
NCT IDNCT04282109
SponsorGrupo Español de Tratamiento de Tumores de Cabeza y Cuello
. Male or female patients aged \<18 years. Patients aged ≥ 70 years old should not be included with a G8 (Geriatric 8) health status screening score \< 14.
✕. Karnofsky \<70%.
✕. Patients that meets more than one of the following criteria:
✕. Karnofsky 70%,
✕. Impaired renal function, creatinine clearance \>30 mL/min and \<80 mL/min GFR could be assessed by direct measurement (EDTA or creatinine clearance) if available or by calculation from serum or plasma creatinine (see annex 5),
✕. Class III heart failure according to the New York Heart Association (annex 9).
✕. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, hear loss and the laboratory values defined in the inclusion criteria.
✕. Histologically confirmed recurrent or metastatic squamous cell carcinoma of unknown primary, of the nasopharynx or non-squamous histologies (eg, mucosal melanoma).