A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck

NCT03576417 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GORTEC 2018-01
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  The time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first.

  3 years after the end of RT

Secondary Outcomes (3)

• Overall survival

  60 months after the end of treatment

• Acute toxicity

  During treatment and until 90 months after the end of RT

• Late toxicity

  1 to 5 years after radiotherapy

Study Arms (2)

RT+ cisplatin

ACTIVE COMPARATOR

100 mg/m2 of cisplatin on days 1, 22,43 of RT

Drug: Cisplatin; Radiation: RT

RT+ cisplatin + nivolumab

EXPERIMENTAL

* 240 mg of nivolumab 3 weeks before RT-Cisplatin * 360 mg of nivolumab on days 1, 22,43 of -RT-cisplatin * 480 mg of nivolumab for maintenance

Drug: Cisplatin; Drug: Nivolumab; Radiation: RT

Interventions

Cisplatin DRUG

Intravenous

RT+ cisplatin; RT+ cisplatin + nivolumab

Nivolumab DRUG

Intravenous

RT+ cisplatin + nivolumab

RT RADIATION

IMRT 66 Gy / 6.5 weeks

Also known as: IMRT

RT+ cisplatin; RT+ cisplatin + nivolumab

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 75 years
• Performance Status (PS) ECOG 0-1 (Appendix 2)
• Written informed consent
• Recording of alcohol consumption and smoking history
• Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx
• Squamous cell carcinoma of the head and neck treated by primary surgery
• Histopathological classification: pStage III or IV. However, Oropharyngeal Cancer pStage II p16 positive with pT3N1 or pT4N1 and tobacco consumption ≥20 packs/year are eligible. (American Joint Committee on Cancer 8th edition)
• Subject must have complete macroscopic resection.
• Subject must be free of disease
• Recovery from the surgical procedure allowing for cisplatin-Radiotherapy
• Radiotherapy planned to start within 4 to 9 weeks after surgery. However, a maximum of 1 additional week could be considered in case of delay due to healing or logistical problem
• Patient/tumor carrying a high risk of relapse with:
• Extra-capsular extension (ECE),
• Multiple peri-neural invasion
• Multiple nodal extension without ECE (≥ 4 nodes)

You may not qualify if:

• Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
• Squamous cell carcinoma involving cervical neck nodes with unknown primary site
• Metastatic disease
• Incomplete macroscopic resection (R2), as stated in the surgical report
• Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV, active autoimmune disease and/or an active immunodeficiency or ongoing immunosuppressive therapy
• Active Central Nervous System disease
• Interstitial lung disease
• Active infection
• Any prior treatment for the current head and neck cancer other than primary surgery. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior RT, or use of any investigational agent
• Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
• Concomitant treatment with any drug on the prohibited medication list such as live vaccines. Live vaccines administered more than 30 days before study entry are permitted
• History of other malignancy within the last 3 years (exception of in situ carcinoma, thyroid papillary carcinoma, skin carcinomas, localized prostate carcinoma Gleason 6 and in situ breast carcinoma)
• Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 5 months after the last dose of nivolumab
• Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 6 months after the last dose of cisplatin.
• Severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis, laboratory abnormalities or other significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• For Drug Consulting: collaborator
• Eurofins: collaborator

Study Sites (1)

Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• Bourhis J, Auperin A, Borel C, Lefebvre G, Racadot S, Geoffrois L, Sun XS, Saada E, Cirauqui B, Rutkowski T, Henry S, Modesto A, Johnson A, Chapet S, Calderon B, Sire C, Malard O, Bainaud M, Da Silva Motta A, Thureau S, Pointreau Y, Blanchard P, Buiret G, Bozec L, Lopez S, Vanbockstael J, Bosset M, Greilsamer C, Daste A, Bruna A, N'Guyen F, Plana M, Iruarrizaga E, Temam S, Even C, Ruiz EP, Bert M, Karamouza E, Thariat J, Kazmierska J, Psyrri A, Mesia R, Tao Y. Nivolumab added to cisplatin and radiotherapy versus cisplatin and radiotherapy alone after surgery for people with squamous cell carcinoma of the head and neck at a high risk of relapse (GORTEC 2018-01 NIVOPOST-OP): a randomised, open-label, phase 3 trial. Lancet. 2026 Jan 24;407(10526):363-374. doi: 10.1016/S0140-6736(25)01850-1. Epub 2025 Dec 22.

  PMID: 41448222 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Nivolumab

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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

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

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 3, 2018
• Study Start: October 10, 2018
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

FR (1)