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Squamous Cell Carcinoma of Head and NeckPhase 3NIVOPOSTOPNCT03576417

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

A Phase 3 study testing Cisplatin, Nivolumab and RT in people with Squamous Cell Carcinoma of Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 ) Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Cisplatin, Nivolumab and RT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
1 siteFrance
Study dates
10 Oct 2018to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Positive margins (R1 or close margin ≤ 1 mm) R1 is microscopic residual disease and close margin is R0 with a minimum margin ≤ 1 mm in any direction.
  • Adequate tumor specimen from archived or resected tissue available for PD-L1, TILs and immune landscape and other biomarker evaluation
  • For oropharyngeal tumor, known p16 status (by IHC)
  • Patient's ability to receive cisplatin 100 mg/m2 for 3 cycles:
  • Creatinine Cclearance (CrCl) ≥ 60 mL/min (measured or calculated by Cockcroft and Gault method) or estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2 (determined by CKDEPI or MDRD method). The highest value should be considered if both are assessed.
  • Absolute neutrophil count ≥1 500/mm3, platelets ≥100 000/mm3, haemoglobin ≥ 9 g/dL, aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL(except Gilbert Syndrom: < 3.0 mg/dL).
  • Peripheral neuropathy ≤ grade 1
  • No hearing loss (assessed clinically and confirmed by audiogram if doubtful)
  • Cardiac function compatible with hyperhydration
  • No administration of prophylactic phenytoin
  • Patients aged 71-74 years,must be fit according to geriatric evaluation

Who cannot join

  • 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
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  • 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
  • Known hypersensitivity to study drugs
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
  • Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
  • Any psychiatric condition (including active suicidal ideation), or psychological, or familial, or sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Individuals deprived of liberty or placed under the authority of a tutor.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase III Randomized Trial of Post-operative Adjuvant Nivolumab and Concomitant Chemo-radiotherapy in High-risk Patients With Resected Squamous Cell Carcinoma of Head and Neck

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 )

Read the detailed description

This open-label, randomized, controlled, multicenter phase III study will include 680 patients who have been operated for their LA SCCHN and exhibiting extra capsular extension (ECE) and/or positive margins (high risk). Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT with or without nivolumab.

The study is designed with the general objective of demonstrating that treatment with nivolumab in combination with 3 cycles of cisplatin during RT is more efficient and not more toxic than the SOC 3 cycles of cisplatin during RT.

Stratification will be based on the P16 status (immunohistochemistry assay on surgical sample). Two classes: Oropharyngeal Cancer (OPC) p16 positive versus OPC p16 negative or not OPC.

Being tested
Cisplatin, Nivolumab, RT
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.

  • CisplatinDrug

    Intravenous

  • NivolumabDrug

    Intravenous

  • RTRadiation

    Also called IMRT

    IMRT 66 Gy / 6.5 weeks

Study groups in NCT03576417
Study groupRoleWhat they receive
RT+ cisplatinActive comparator100 mg/m2 of cisplatin on days 1, 22,43 of RT
Receives: Drug: Cisplatin; Radiation: RT
RT+ cisplatin + nivolumabExperimental* 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
Receives: Drug: Cisplatin; Drug: Nivolumab; Radiation: RT

What is being measured

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

  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.

    Measured: 3 years after the end of RT

Secondary outcomes (3)

  1. Overall survival

    Time between the date of randomization and death

    Measured: 60 months after the end of treatment

  2. Acute toxicity

    The maximal grade of each toxicity observed during radiotherapy plus concomitant treatment graded according to the NCI CTCAE v5.0

    Measured: During treatment and until 90 months after the end of RT

  3. Late toxicity

    Late toxicity from 1 year to 5 years after radiotherapy will be categorized in three categories (none, grade 1-2, or grade 3-4), and compared between the two arms using generalised linear models for multinomial variables with a cumulative logit link

    Measured: 1 to 5 years after radiotherapy

Timeline

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

  1. First posted3 Jul 2018
  2. Study start10 Oct 2018
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03576417
Sponsor's protocol ID
GORTEC 2018-01
Acronym
NIVOPOSTOP
Status last verified
Sep 2026
First submitted
1 Jun 2018
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41448222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Nivolumab and RT in people with Squamous Cell Carcinoma of Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

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 26 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

This study is still under way. Results are not available in the source record yet.

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?

Disease free survival (time frame: 3 years after the end of RT). 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 NCT03576417, which also lists 1 linked publication.

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 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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