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)

STATUS

Recruiting
End date

Sep 29, 2026
participants needed

141
sponsor

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

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Updated on 19 February 2024

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psychiatric disorder

cancer

diabetes

pulmonary disease

platelet count

corticosteroids

ct scan

heart disease

serum pregnancy test

measurable disease

metastasis

carboplatin

hearing loss

neutrophil count

nivolumab

squamous cell carcinoma of head and neck

squamous cell carcinoma

paclitaxel

monoclonal antibodies

liver metastasis

edta

immunosuppressive agents

pulmonary function tests

carcinoma

cetuximab

major surgery

renal impairment

skin disorder

autoimmune disease

kidney function tests

immunodeficiency

adjuvant therapy

neuropathy

head and neck cancer

hepatitis b

neck cancer

hepatitis c antibody

oropharyngeal

metastatic squamous cell carcinoma

caries

vitiligo

squamous cell carcinoma of unknown primary

pneumonitis

interstitial lung disease

tumor of the oropharynx

central nervous system disease

leptomeningeal metastases

adjuvant

melanoma

cisplatin

autoimmune thyroiditis

cutaneous malignant melanoma

metastatic head and neck squamous cell cancer

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.

Details

Condition	Recurrent Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer Stage IV
Age	18years - 100years
Treatment	Nivolumab + Paclitaxel, Cetuximab + Paclitaxel
Clinical Study Identifier	NCT04282109
Sponsor	Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care
	Histologically confirmed recurrent or metastatic 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 evaluable disease. Measurable disease as defined by RECIST version 1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease
	Patients unable for cisplatin-based chemotherapy, defined "unable" by
	Karnofsky 70% or
	Karnofsky 80-100% and amenable to chemotherapy, but
	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), or
	ii. grade 2 hearing loss, according to the NCI CTCAE v 5.0, or
	iii. Class III heart failure according to the New York Heart Association
	(annex 9), or
	iv. History of allergic reactions to cisplatin, carboplatin, or other
	platinum-containing compounds or
	v. Prior dose of cisplatin 225 mg/m for locally advanced disease (a patient
	who received prior RT + 3 cycles of cisplatin 100 mg/m2 or 3 cycles induction
	TPF (with cisplatin 75/m2) for locally advanced primary HN cancer can be
	included), or
	vi. Disease progression or relapse during or within 6 months of receiving
	platinum-based therapy administered as neoadjuvant, adjuvant therapy or as
	concomitant chemotherapy with radiotherapy and have received at least 200
	mg/m2 of cisplatin
	\. 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
	\. Clinical laboratory values as specified below within 28 days before the
	first dose of study drug
	Total bilirubin must be 2 the upper limit of normal (ULN)
	Magnesium lower limit of normal
	Calcium lower limit of normal
	ALT and AST must be 3 ULN unless liver metastases are present, in which case they must be 5x ULN
	Hemoglobin must be 9 g/dL, absolute neutrophil count (ANC) must be 1.500/L, WBC must be 2.000/L and platelet count must be 100.000/L
	Subjects who have received radiation as primary therapy are eligible if radiation therapy treatment was completed > 4 weeks prior to inclusion
	Subjects who have previously received chemotherapy as part of the initial multimodality treatment for locally advanced disease are eligible if the chemotherapy was completed > 24 weeks prior to inclusion
	Documentation of PD-L1 status by IHC performed by the central lab at randomization. A pre-treatment tumor tissue sample should be sent. If several tumor samples are available, testing should be performed on the most recently obtained tumor sample
	Documentation of HPV p16 status (OPC) is required for HNSCC tumor of the oropharynx. For subjects with oropharyngeal cancer, sites are defined in annex 8. HPV status of tumor tissue has to be locally determined at screening by any of the following methods: p16 IHC, in situ hybridization, or polymerase chain reaction based assay. If HPV status by p16 IHC is positive result confirmation by PCR is mandatory
Exclusion Criteria
	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%
	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)
	Active brain metastases or leptomeningeal metastases
	Carcinomatous meningitis
	Active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included
	Diagnosis of immunodeficiency or any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
	History of pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
	Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function
	Prior therapy with experimental antitumor vaccines; any T-cell co-stimulation agents or inhibitors of checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody; or other agents specifically targeting T cells are prohibited
	Any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
	Life-threatening illness unrelated to cancer
	Female patients who are lactating and breast-feeding or a positive serum pregnancy test during the screening period
	Systemic anticancer treatment or radiotherapy less than 4 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment or not recovered from acute toxic effects from prior chemotherapy and radiotherapy
	Prior treatment with investigational agents 21 days (4 weeks for monoclonal antibodies with evidence of PD) or 5 their half-lives (whichever is shorter) before the first dose of study treatment. A minimum of 10 days should elapse from prior therapy to initiating protocol therapy
	Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery
	Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug
	Known human immunodeficiency virus (HIV) positive (testing not required), or known acquired immunodeficiency syndrome (AIDS)
	Patients with positive test for hepatitis B virus or hepatitis C virus indicating presence of virus, eg, Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative)
	Active secondary malignancy that requires treatment. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period
	Any clinically significant co-morbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study
	Patients with history of allergy to study drugs components excipients
	Symptomatic peripheral neuropathy of Grade 2 based on the CTCAE v5.0
	Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event 8 weeks prior to starting the study treatment
	History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
	History of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor EL (polyoxyethylated castor oil)

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squamous cell carcinoma of head and neck

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immunosuppressive agents

pulmonary function tests

kidney function tests

metastatic squamous cell carcinoma

caries

vitiligo

squamous cell carcinoma of unknown primary

pneumonitis

interstitial lung disease

tumor of the oropharynx

central nervous system disease

leptomeningeal metastases

adjuvant

melanoma

cisplatin

autoimmune thyroiditis

cutaneous malignant melanoma

metastatic head and neck squamous cell cancer

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Study Definition

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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)