Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaPhase 2NIVOTAXNCT04282109
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)
A Phase 2 study testing Nivolumab + Paclitaxel and Cetuximab + Paclitaxel in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 21 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nivolumab + Paclitaxel and Cetuximab + Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 21 sitesSpain
- Study dates
- 3 Jun 2020to 21 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- grade ≥2 hearing loss, according to the NCI CTCAE v 5.0, or
- Class III heart failure according to the New York Heart Association (annex 9), or
- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds or
- Prior dose of cisplatin ≥225 mg/m² 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
- 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/µL, WBC must be ≥2.000/µL and platelet count must be ≥100.000/µL.
- Subjects who have received radiation as primary therapy are eligible if radiation therapy treatment was completed > 4 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. A newly obtained biopsy (within 6 months prior to start of study treatment) is preferred but an archival sample is acceptable, 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.
Who cannot join
- 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).
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- 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 hypersensitivity reactions to study drugs (nivolumab, cetuximab or paclitaxel) or any of their 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Centro Oncoloxico de Galicia
A Coruña, 15009
Hospital Universitari Germans Trias i Pujol de Badalona
Badalona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Institut Català D´Oncologia- Hospital Duran i Reynals
Barcelona, 08908
Hospital Universitari de Girona Dr. Josep
Girona, 17007
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Clínico San Carlos
Madrid, 28040
Hospital 12 de Octubre
Madrid
Hospital Universitario Regional de Málaga
Málaga, 29010
Complejo Hospitalario de Navarra
Pamplona, 31008
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea
San Sebastián, San Sebastían, 20014
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Virgen de la Salud
Toledo, 45004
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Universitario y Politécnico la Fe
Valencia, 46026
Hospital Clínico Universitario Lozano
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Phase II Multicenter Randomized Trial to Assess the Efficacy and Safety of First Line Nivolumab in Combination With Paclitaxel in Subjects With R/M HNSCC Unable for Cisplatin-based Chemotherapy (NIVOTAX)
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.
- Being tested
- Nivolumab + Paclitaxel, Cetuximab + Paclitaxel
- Keywords
- Head and neck cancer, Squamous cell carcinoma, Nivolumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + PaclitaxelDrug
Combination treatment: Nivolumab 240 mg will be administered via IV infusion every 2 weeks. Paclitaxel 80mg/m2 will be administered via IV infusion weekly. After 12 weeks from the start of the combined treatment paclitaxel will be stopped.
Maintenance treatment with nivolumab 480 mg every 4 weeks will start two weeks after the last administration of nivolumab 240 mg. Once nivolumab is administered at 480 mg, paclitaxel can no longer be administered.
Nivolumab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months.
Cetuximab + PaclitaxelDrug
Combination treatment: Cetuximab 250 mg/m2 (first dose of 400 mg/m2) administered via IV infusion weekly plus weekly paclitaxel (80 mg/m2) administered via IV infusion.
After 12 weeks from the start of the combined treatment paclitaxel will be stopped and weekly cetuximab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | NIVOTAX (nivolumab + paclitaxel, follow by maintenance with nivolumab) Receives: Drug: Nivolumab + Paclitaxel |
| Arm 2 | Active comparator | ERBITAX (cetuximab + paclitaxel, follow by maintenance with cetuximab) Receives: Drug: Cetuximab + Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two Years Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive.
Measured: 2 years
Secondary outcomes (21)
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the date of first documented disease progression, as assessed by the investigator using RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Measured: Up to 45 months
Overall Response Rate (ORR)
ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects for each treatment group.
Measured: Up to 2 years
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the number of subjects with a best overall response (BOR) of a complete response (CR), partial response (PR) or stable disease (SD) divided by the number of randomized subjects for each treatment group.
Measured: Up to 2 years
Duration of Response (DoR)
Duration of Response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first.
Measured: Up to 45 months
6-months Progression-free Survival Rate
Probability of progression at 6 months.
Measured: 6 months
Overall Survival in Patients ≥ 70 Years.
OS is defined as the time between the date of randomization and the date of death.
Measured: Up to 45 months
Progression Free Survival in Patients ≥ 70 Years.
PFS is defined as the time from randomization to the date of first documented disease progression, as assessed by the investigator using RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Measured: Up to 45 months
Overall Response Rate in Patients ≥ 70 Years.
ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects for each treatment group.
Measured: Up to 2 years
Overall Survival Based on PDL1 Expression (CPS).
OS is defined as the time between the date of randomization and the date of death.
Measured: Up to 45 months
Progression Free Survival Based on PDL1 Expression (CPS).
PFS is defined as the time from randomization to the date of first documented disease progression, as assessed by the investigator using RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Measured: Up to 45 months
Overall Response Rate Based on PDL1 Expression (CPS).
ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects for each treatment group.
Measured: Up to 2 years
Overall Survival Based on Cisplatin Ineligibility.
OS is defined as the time between the date of randomization and the date of death.
Measured: Up to 45 months
Progression Free Survival Based on Cisplatin Ineligibility.
PFS is defined as the time from randomization to the date of first documented disease progression, as assessed by the investigator using RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Measured: Up to 45 months
Overall Response Rate Based on Cisplatin Ineligibility.
ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects for each treatment group.
Measured: Up to 2 years
Overall Survival Based on Karnofsky.
OS is defined as the time between the date of randomization and the date of death.
Measured: Up to 45 months
Progression Free Survival Based on Karnofsky.
PFS is defined as the time from randomization to the date of first documented disease progression, as assessed by the investigator using RECIST 1.1 criteria, or death due to any cause, whichever occurs first.
Measured: Up to 45 months
Overall Response Rate Based on Karnofsky.
ORR is defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects for each treatment group.
Measured: Up to 2 years
Percentage of Patients With AEs
Percentage of patients with AEs in relation with total number of treated patients
Measured: 2 years
Percentage of Patients With Grade 3 and Grade 4 AEs
Percentage of patients with Grade 3 and Grade 4 AEs in relation with total number of treated patients
Measured: 2 years
Percentage of Patients With SAEs
Percentage of patients with SAEs in relation with total number of treated patients
Measured: Up to 45 months
Percentage of Patients Who Discontinued Due to AEs
Percentage of patients who discontinued due to AEs in relation with total number of treated patients
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start3 Jun 2020
- Primary completion1 Sep 2023
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Ricard Mesia, MD, Principal investigator, Hospital Universitari Germans Trias i Pujol de BadalonaLara Iglesias, MD, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282109
- Sponsor's protocol ID
- TTCC-2019-01/CA209-7HE
- Other IDs
- 2019-002922-60, 2019
- Acronym
- NIVOTAX
- Status last verified
- Jun 2025
- First submitted
- 12 Feb 2020
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Randomized Trial to Assess the Efficacy and Safety of First Line Nivolumab in Combination With Paclitaxel in Subjects With R/M HNSCC Unable for Cisplatin-based Chemotherapy (NIVOTAX)
- ClinicalTrials.gov ID
- NCT04282109
- Acronym / sponsor ID
- NIVOTAX / TTCC-2019-01/CA209-7HE
- Keywords
- Head and neck cancer, Squamous cell carcinoma, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y CuelloUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Apices Soluciones S.L.
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nivolumab + PaclitaxelNIVOTAX (nivolumab + paclitaxel, follow by maintenance with nivolumab) |
| Arm 2 | Active comparator | Drug: Cetuximab + PaclitaxelERBITAX (cetuximab + paclitaxel, follow by maintenance with cetuximab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (30 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab + PaclitaxelCombination treatment: Nivolumab 240 mg will be administered via IV infusion every 2 weeks. Paclitaxel 80mg/m2 will be administered via IV infusion weekly. After 12 weeks from the start of the combined treatment paclitaxel will be stopped. Maintenance treatment with nivolumab 480 mg every 4 weeks will start two weeks after the last administration of nivolumab 240 mg. Once nivolumab is administered at 480 mg, paclitaxel can no longer be administered. Nivolumab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months. | Drug | Arm 1 |
| Cetuximab + PaclitaxelCombination treatment: Cetuximab 250 mg/m2 (first dose of 400 mg/m2) administered via IV infusion weekly plus weekly paclitaxel (80 mg/m2) administered via IV infusion. After 12 weeks from the start of the combined treatment paclitaxel will be stopped and weekly cetuximab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months. | Drug | Arm 2 |
Primary outcome
Two Years Overall Survival (OS)
Time frame: 2 years
OS is defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive.
21 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 45 months
Overall Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 45 months
6-months Progression-free Survival Rate
Time frame: 6 months
Overall Survival in Patients ≥ 70 Years.
Time frame: Up to 45 months
Progression Free Survival in Patients ≥ 70 Years.
Time frame: Up to 45 months
Overall Response Rate in Patients ≥ 70 Years.
Time frame: Up to 2 years
Overall Survival Based on PDL1 Expression (CPS).
Time frame: Up to 45 months
Progression Free Survival Based on PDL1 Expression (CPS).
Time frame: Up to 45 months
Overall Response Rate Based on PDL1 Expression (CPS).
Time frame: Up to 2 years
Overall Survival Based on Cisplatin Ineligibility.
Time frame: Up to 45 months
Progression Free Survival Based on Cisplatin Ineligibility.
Time frame: Up to 45 months
Overall Response Rate Based on Cisplatin Ineligibility.
Time frame: Up to 2 years
Overall Survival Based on Karnofsky.
Time frame: Up to 45 months
Progression Free Survival Based on Karnofsky.
Time frame: Up to 45 months
Overall Response Rate Based on Karnofsky.
Time frame: Up to 2 years
Percentage of Patients With AEs
Time frame: 2 years
Percentage of Patients With Grade 3 and Grade 4 AEs
Time frame: 2 years
Percentage of Patients With SAEs
Time frame: Up to 45 months
Percentage of Patients Who Discontinued Due to AEs
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricard Mesia, MD principal investigator
Hospital Universitari Germans Trias i Pujol de Badalona
Lara Iglesias, MD principal investigator
Hospital Universitario 12 de Octubre
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab + Paclitaxel and Cetuximab + Paclitaxel in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 21 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two Years Overall Survival (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.