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Head and Neck Squamous Cell CarcinomaPhase 2ADJORL1NCT03406247

Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Nivolumab and Ipilimumab in people with Head and Neck Squamous Cell Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Two randomized trials of reirradiation after salvage surgery have been conducted by the GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first trial compared reirradiation and a "wait and see attitude" and was published in 2008 [1]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Nivolumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteFrance
Study dates
12 Feb 2018to Nov 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrence or second primary of HNSCC in a previously irradiated area at a dose ≥ 50 Gys
  • HNSCC of oral cavity, oro and hypopharynx, larynx only if extralaryngeal spread (rT4), isolated nodal recurrence
  • Patient who has received salvage surgery with curative intent and macroscopic complete resection:
  • for cohorts 1 and 2: similarly to inclusion criteria of previous reirradiation trials, more than 6 months between radiotherapy and salvage surgery
  • for cohorts 1bis and 2bis: less than 6 months between radiotherapy and salvage surgery
  • Recurrence of bad prognosis justifying an adjuvant treatment:
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  • clinically infiltrative recurrence or second primary; or nodal recurrence upper or equal to 3 cm, or association of local and nodal recurrence;
  • superficial recurrence, but histologic gravity signs on surgical specimen indicating a high risk of recurrence after salvage surgery (histologic involvement of surgical margins or margins less than 3mm, perineural spread or vascular emboli, multiples invaded nodes). Nodal recurrence without tumor recurrence and inferior to 3cm, but with capsular rupture at histologic examination.
  • Sufficient healing for beginning adjuvant treatment within 8 weeks (+/- 2 weeks) of salvage surgery
  • No distant metastases, confirmed by CT or PET scan
  • Male and female between 18 and 75 years (included)
  • ECOG 0 or 1
  • 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
  • Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 14 days to the administration of the first study treatment.: WBC > 2,000/μL. Polynuclear neutrophils >1.5 x 10^9/L. Platelets > 75 x 10^9/L. Hemoglobin > 8.0 g/dL. ALAT/ASAT< 3.0 x ULN. Bilirubin < 1.5 x ULN (except Gilbert Syndrome
  • : < 3.0 mg/dL). Creatinine clearance > 40 mL/min (measured or calculated by Cockroft and Gault formula) or serum creatinine < 2.0 x ULN
  • Women of childbearing potential must have a negative serum β-HCG pregnancy test within 24 hours prior to the administration of the first study treatment.
  • Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for at least 5 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 7 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
  • Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 5 months after the last dose.
  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be affiliated to a social security system or beneficiary of the same

Who cannot join

  • Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma that originated from the skin and salivary gland, or nonsquamous histologies (eg, mucosal melanoma).
  • Recurrence or second primary of HNSCC in a non previously irradiated area, or at a dose < 50 Gys
  • Macroscopic incomplete surgery (no debulking allowed)
  • Superficial recurrence without nodal recurrence, and without histologic gravity signs (histologic involvement of surgical margins, perineural spread)
  • Nodal recurrence less than 3 cm, without local recurrence and without capsular rupture at histologic examination
  • Serious medical adverse conditions, such as severe cardiac and/or pneumologic and/or liver dysfunction. Non exhaustive list, to be appreciated in each center
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  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition 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.
  • Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
  • Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • 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.
  • Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Patients receiving anti-cancer therapies must be discontinued at least 4 weeks prior to administration of study drug. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids, except replacement organotherapy (hydrocortisone and fludrocortisone), must be discontinued at least 2 weeks before administration of study drug. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or to baseline or stabilized before administration of study drug. Subjects with toxicities attributed to systemic prior anticancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll.
  • Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to study drug. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed.Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events.
  • Patients requiring concomitant treatment with therapeutic doses of anticoagulants will not be eligible for this clinical trial. Patients treated with low dose of anticoagulants for thrombo-embolic events prophylaxis are allowed.
  • History of auto immune, immune mediated inflammatory disease including but not limited to colitis, pneumonitis, hepatitis, nephritis, inflammatory of skin, SNC, eyes, glands producing hormones
  • Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
  • History of severe hypersensitivity reaction to any monoclonal antibody
  • History of allergy to study drugs components
  • Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
  • Pregnancy or breastfeeding
  • Psychological, familial or social factor incompatible with informed consent, and regular follow-up.
  • Previous allogenic stem cell transplant or patients recipient of solid organ transplant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alix MARHIC, MD contact

+33 (0)1 42 11 42 11

alix.marhic@gustaveroussy.fr

Elodie LECERF contact

+33 (0)1 42 11 42 11

elodie.lecerf@gustaveroussy.fr

France1 site, 1 recruiting

  • Gustave Roussy

    Villejuif, Val De Marne, 94805

    Alix MARHIC, MD, +33 0)1 42 11 42 11, alix.marhic@gustaveroussy.fr

    Alix MARHIC, MD

    Recruiting

Other trials in France

About this study

Official title: Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma : Phase 2 Trial Evaluating the Efficacy and the Toxicity of Nivolumab Alone, and of the Combination Nivolumab and Ipilimumab

Two randomized trials of reirradiation after salvage surgery have been conducted by the GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first trial compared reirradiation and a "wait and see attitude" and was published in 2008 [1]. The second trial compared two modalities of reirradiation. Our hypothesis is that adjuvant treatment with immunotherapy will lead to a DFS similar to that observed in previous trials of post-operative reirradiation with possibly lower toxicity.

Being tested
Nivolumab, Ipilimumab
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.

  • NivolumabDrug

    Patients in cohorts 1 and 1bis will be administered Nivolumab 240 mg every 2 weeks during 3 first months and then 480 mg every 4 weeks during 3 months Patients in cohorts 2 and 2bis will be administered

    • nivolumab 240 mg every 2 weeks during 6 months

  • IpilimumabDrug

    Patients in cohorts 2 and 2bis will be administered

    • ipilimumab 1mg/kg IV every 6 weeks during 6 months
Study groups in NCT03406247
Study groupRoleWhat they receive
NivolumabExperimentalPatients in cohorts 1 and 1bis will be administered Nivolumab 240 mg every 2 weeks during 3 first months and then 480 mg every 4 weeks during 3 months
Receives: Drug: Nivolumab
Nivolumab + IpilimumabExperimentalPatients in cohorts 2 and 2bis will be administered * nivolumab 240 mg every 2 weeks during 6 months * ipilimumab 1mg/kg IV every 6 weeks during 6 months
Receives: Drug: Nivolumab; Drug: Ipilimumab

What is being measured

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

  1. Two Years Disease Free Survival

    defined as the time from the beginning of the immunotherapy and the first locoregional or distant recurrence, or death from any cause, in cohorts 1 and 2

    Measured: Two years

Timeline

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

  1. First posted23 Jan 2018
  2. Study start12 Feb 2018
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406247
Sponsor's protocol ID
2024-516810-39-00
Other IDs
2017/2536
Acronym
ADJORL1
Status last verified
May 2025
First submitted
15 Jan 2018
Last updated
8 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Head and Neck Squamous Cell Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris 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 20 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 8 May 2025. 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 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?

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?

Contact Alix MARHIC, MD (+33 (0)1 42 11 42 11, alix.marhic@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two Years Disease Free Survival (time frame: Two years). 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 NCT03406247.

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 8 May 2025.

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