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Squamous Cell Carcinoma of Head and NeckPhase 3NIVACTORNCT05802290

NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN

A Phase 3 study testing Nivolumab 240 MG in 24 ML Injection in people with Squamous Cell Carcinoma of Head and Neck, run by Gruppo Oncologico del Nord-Ovest at 23 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Nivolumab 240 MG in 24 ML Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
23 sitesItaly
Study dates
27 Nov 2017to 26 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Signed Written Informed Consent;
  • Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
  • Males and Females, 18 years of age;
  • Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx) not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy), p16 positive SCCHN of unknown primary;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  • Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie, with radiation after surgery), primary (ie, with radiation or prior to it or to surgery as induction chemotherapy), recurrent, or metastatic setting;
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  • Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
  • Documentation of p16-positive or p16-negative disease to determine human papillomavirus (HPV) status of oropharyngeal cancer
  • Tumor tissue (archival or fresh biopsy specimen) must be available;
  • Patients with CNS metastases:
  • Patients are eligible if CNS metastases are treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must be either off corticosteroids or on a stable or decreasing dose ≤ 10 mg daily prednisone (or equivalent) OR
  • Patients are eligible if they have previously untreated CNS metastases and are neurologically asymptomatic. In addition, patients must be either off corticosteroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent);
  • Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration;
  • Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test;
  • Screening laboratory values must meet the following criteria (using CTCAE v4.03) and should be obtained within 14 days prior to the initial administration of study drug:
  • WBC ≥ 2000/μL
  • Neutrophils ≥1500/μL
  • Platelets ≥100 x103/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Serum creatinine ≤ 1.5 x ULN o AST/ALT ≤ 3 x ULN
  • Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
  • Calcium levels must be normalized and maintained within normal limits for study entry and on treatment. Medical management of calcium levels is permitted. Note: Normal calcium levels may be based on ionized calcium or adjusted for albumin.
  • Subjects with an initial magnesium < 0.5 mmol/L (1.2 mg/dL) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion.
  • Women must not be breastfeeding.
  • WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for a total of 23 weeks post treatment completion;
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 halflives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 31 weeks post treatment completion.

Who cannot join

  • Patients with untreated, symptomatic CNS metastases are excluded;
  • Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, p16 negative squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg, mucosal melanoma) are not allowed;
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results;
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast;
  • Subjects with active, known or suspected autoimmune disease. Subjects with experienced GVH disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition or previous neck RT only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
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  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
  • All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enroll.
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Subjects who test positive for HCV antibody but negative for HCV ribonucleic acid are permitted to enroll;
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
  • Any Grade 4 laboratory abnormalities;
  • History of allergy to study drug components;
  • History of severe hypersensitivity reaction to any monoclonal antibody;
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Italy23 sites

  • Ospedale Papa Giovanni XXIII

    Bergamo

  • Ospedale Bellaria

    Bologna

  • IRCCS di Candiolo

    Candiolo

  • Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncoematologia

    Cuneo, 12100

  • Az.Ospedaliera S.Croce e Carle

    Cuneo

  • P.O. "Vito Fazzi"

    Lecce

  • Azienda USL Toscana Nord Ovest

    Livorno

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20126

  • IRCCS Ospedale San Raffaele

    Milan

  • Istituto Europeo di Oncologia

    Milan

  • Ospedale San Paolo

    Milan

  • Istituto Tumori Napoli - Fondazione Pascale

    Naples

  • Istituto Oncologico Veneto IRCCS

    Padova

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo

  • Ospedale S.Chiara - A.O.U.P.

    Pisa

  • Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale Generale "S. Giovanni Calibita" Fatebenefratelli Isola Tiberina

    Roma

  • Policlinico Universitario "Agostino Gemelli"

    Roma

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Ospedale S. Paolo

    Savona

  • Ospedale San Paolo

    Savona

  • AOU Città della Salute e della Scienza di Torino

    Torino

  • ASST Vimercate

    Vimercate

Other trials in Italy

About this study

Official title: A Single-Arm, Open-Label, Multicenter, Phase IIIb Clinical Trial With NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy Squamous Cell Carcinoma of the Head and Neck (SCCHN) - NIVACTOR Study

Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent. This study is designed to better evaluate the safety profile of nivolumab in a large series of patients with Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck. The primary endpoint of this study is the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events.

Read the detailed description

This clinical trial has established head and neck squamous cell carcinoma as responsive to immunotherapy and nivolumab as a new potential SOC for these patients. As concern safety, high-grade (CTCAE v4.03 Grade 3 or higher), treatment-related, select adverse events occur with a low frequency in patients with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) treated with nivolumab monotherapy. Nonetheless, this observation arises from patients treated in clinical trial and selected according to clear inclusion and exclusion criteria. Therefore they may not precisely reflect the clinical practice. Using a single large study is warranted in order to expand the safety database and to improve the knowledge on estimated incidence of uncommon, select, high-grade AEs.

Being tested
Nivolumab 240 MG in 24 ML Injection
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab 240 MG in 24 ML InjectionDrug

    Also called Opdivo

    nivolumab monotherapy at 240mg flat dose as a 30-minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent

Study groups in NCT05802290
Study groupRoleWhat they receive
nivolumabExperimentalnivolumab monotherapy at 240mg flat dose as a 30-minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent
Receives: Drug: Nivolumab 240 MG in 24 ML Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of high-grade (CTCAE v 4.03 Grade 3 or higher) treatment related AE

    To determine the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events in patients with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) treated with nivolumab monotherapy;

    Measured: From baseline to 100 days after last study treatment

Secondary outcomes (3)

  1. Incidence of all high-grade (Grades 3-5), select adverse events;

    To determine the incidence and to characterise the outcome (duration of serious adverse events [SAE] treatment, dose of immune-modulating agents [ie, steroids] dose of agents used, time to event onset, and event resolution, and worst grade of event) of all high-grade (CTCAE v 4.03 Grade 3 or higher) adverse events

    Measured: From baseline to 100 days after last study treatment

  2. Overall Survival

    Defined as the time from first study treatment to death from any cause

    Measured: At study end 2 years from last patient enrolled

  3. Objective Response Rate

    defined as the proportion of response-evaluable patients with a best overall response of CR or PR

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 24 moths)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start27 Nov 2017
  3. Primary completion26 Mar 2020
  4. Study completion26 Mar 2020

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A Single-Arm, Open-Label
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05802290
Sponsor's protocol ID
NIVACTOR
Acronym
NIVACTOR
Status last verified
May 2022
First submitted
18 Jan 2021
Last updated
6 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab 240 MG in 24 ML Injection in people with Squamous Cell Carcinoma of Head and Neck, run by Gruppo Oncologico del Nord-Ovest at 23 sites in Italy.

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 27 inclusion and 15 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of high-grade (CTCAE v 4.03 Grade 3 or higher) treatment related AE (time frame: From baseline to 100 days after last study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05802290.

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 6 Apr 2023.

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