NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN

NCT05802290 | Completed Phase 3

• 1 other identifier: NIVACTOR
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 23

Brief 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. 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (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;

  From baseline to 100 days after last study treatment

Secondary Outcomes (3)

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

  From baseline to 100 days after last study treatment

• Overall Survival

  At study end 2 years from last patient enrolled

• Objective Response Rate

  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)

Study Arms (1)

nivolumab

EXPERIMENTAL

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

Drug: Nivolumab 240 MG in 24 ML Injection

Interventions

Nivolumab 240 MG in 24 ML Injection DRUG

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

Also known as: Opdivo

nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gruppo Oncologico del Nord-Ovest: lead

Study Sites (23)

Ospedale Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale Bellaria

Bologna, Italy

Location

IRCCS di Candiolo

Candiolo, Italy

Location

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

Cuneo, 12100, Italy

Location

Az.Ospedaliera S.Croce e Carle

Cuneo, Italy

Location

P.O. "Vito Fazzi"

Lecce, Italy

Location

Azienda USL Toscana Nord Ovest

Livorno, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20126, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Ospedale San Paolo

Milan, Italy

Location

Istituto Tumori Napoli - Fondazione Pascale

Napoli, Italy

Location

Istituto Oncologico Veneto IRCCS

Padua, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Location

Ospedale S.Chiara - A.O.U.P.

Pisa, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

Ospedale Generale "S. Giovanni Calibita" Fatebenefratelli Isola Tiberina

Roma, Italy

Location

Policlinico Universitario "Agostino Gemelli"

Roma, Italy

Location

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Ospedale S. Paolo

Savona, Italy

Location

Ospedale San Paolo

Savona, Italy

Location

AOU Città della Salute e della Scienza di Torino

Torino, Italy

Location

ASST Vimercate

Vimercate, Italy

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Nivolumab; Injections

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lisa Licitra, prof

  Fondazione IRCCS Istituto Nazionale Tumori e Università di Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Single-Arm, Open-Label

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: April 6, 2023
• Study Start: November 27, 2017
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: April 6, 2023

Record last verified: 2022-05

Locations

IT (23)