Oropharynx CancerPhase 2IMMUNEBOOSTNCT03838263
Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer
A Phase 2 study testing Nivolumab and Chemoradiation in people with Oropharynx Cancer, run by UNICANCER at 11 sites in France.
Trial summary
The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Nivolumab and Chemoradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 11 sitesFrance
- Study dates
- 25 Jul 2019to 20 Nov 2024
- Phase
- Phase 2
- 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
- Age ≥18 years old
- Histologically confirmed HPV-positive Oropharyngeal squamous cell carcinoma (OPSCC) amenable to curative treatment with RT-CT (HPV status is defined on the basis of the combination of 2 assays: p16 protein overexpression assessed by immunohistochemistry (IHC) and high-risk HPV DNA identification by in-situ Hybridization (ISH) or PCR. An HPV-driven OPSCC is defined as a tumor that is positive for both p16 IHC and HPV-DNA ISH or PCR)
- According to the 8th TNM edition, eligible stages are as follow:
- Irrespective of tobacco consumption: Stage T4 (any N), N2 or N3 (any T)
- Only if tobacco consumption ≥10 pack- years: T1-3N1 and T3N0 (T1N0 and T2N0 irrespective of tobacco consumption are not eligible for the study)
- Planned date of chemoradiation allowing 2 treatment infusions, 2 weeks apart
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Screening laboratory values must meet the following criteria (using CTCAE v5.0) and should be obtained within 7 days prior to the randomisation:
- Polynuclear neutrophils ≥1.5 x 10⁹/L
- Platelets ≥100 x 10⁹/L
- Hemoglobin ≥9.0 g/dL
- Alanine aminotransferase (ALAT)/aspartate transaminase (ASAT) ≤2.5 x upper limit of normal (ULN)
- Total Bilirubin ≤1.5 x ULN (except Gilbert Syndrome : <3.0 mg/dL)
- Creatinine clearance ≥60 mL/min (measured or calculated by Cockcroft and Gault formula)
- Potentially reproductive patients must agree to use a highly effective contraceptive method while on treatment and up to 6 months after the end of chemoradiation
- Women of childbearing potential must have a negative serum or urine pregnancy test done within 72 hours before randomisation
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures (including mandatory study-specific biopsies)
- Subjects must have at least one lesion amenable to biopsy
- Subjects must have at least one measurable lesion (different from the lesion amenable to biopsy) as per RECIST v1.1 to assess efficacy
- Consent to provide archived tumour tissue sample, if available
- Patients must be affiliated to a Social Security System
- Patient information and written informed consent form signed
Who cannot join
- Prior treatment for OPSCC
- Prior treatment with anti PD-1/PD-L1 and CTLA-4
- Distant metastases
- Tumour embolization within 28 days prior to the first dose of study drug.
- Contra-indication(s) to receive high-dose cisplatin as listed in the most updated Summary of Product Characteristics (including creatinine clearance <60 mL/min, pre-existing hearing loss or neurological disorder)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness and social situations that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent
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- Current or prior use of immunosuppressive medication within 14 days before the first dose, including intranasal and inhaled corticosteroids or systemic corticosteroids
- Active or prior documented autoimmune or inflammatory disease within the 2 years prior to start of treatment (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn's disease], celiac disease, irritable bowel disease, or other serious chronic gastrointestinal conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis, etc.) The following are exceptions to these criteria:a) Subjects with vitiligo or alopecia, b) Subjects with hypothyroidism (e.g.,Hashimoto syndrome) stable on hormone replacement and c) Subjects with psoriasis not requiring systemic treatment (within the past 2 years)
- History of primary immunodeficiency or organ transplant requiring immunosuppressive drugs
- Patients with a known HIV, active hepatitis B or C infection
- Other invasive malignancy within 3 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured
- Pregnant women or women who are breast-feeding
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
- Individuals deprived of liberty or placed under the authority of a tutor
- Severe infection requiring parenteral antibiotics treatment
- Known history or active symptomatic interstitial lung disease
- Patients with major surgery within 28 days, or open biopsy within 7 days, prior to randomisation. Patients must have recovered from major side effects of the surgery before randomisation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut Sainte Catherine
Avignon, 84918
Hopital Beaujon
Clichy, 92100
Centre Léon Bérard
Lyon, 69373
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75005
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Tenon
Paris, 75970
Centre Henri Becquerel
Rouen, 76038
Hopital Foch
Suresnes, 92150
Institut de cancerologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer
The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer
Read the detailed description
Methodology:
Patient screened wil be randomized 2:1 between 2 arms:
- Experimental arm: Nivolumab 2 infusions (2 weeks part) before standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7
- Control arm: Standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7
Primary Objective:
To assess the feasibility and tolerance of neoadjuvant nivolumab treatment before chemoradiation in "high-risk" HPV-driven Oropharynx Cancer
- Conditions
- Oropharynx Cancer
- Being tested
- Nivolumab, Chemoradiation
- Keywords
- Nivolumab, High-risk, HPV-driven oropharynx cancer
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called ANY
2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.
ChemoradiationRadiation
Also called Radiation + cisplatin
Standard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7 Receives: Drug: Nivolumab; Radiation: Chemoradiation |
| Control arm | Active comparator | Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7 Receives: Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients that fulfill the 3 or 5 conditions as described below (Feasibility assessment of nivolumab neoadjuvant treatment before chemoradiation)
the rate of patients :
(1) who can receive the 2 nivolumab infusions planned at D1 and between D14 to D16 among patients in the experimental arm And (2) who can receive chemoradiation at D30 (-2 /+7) after the second nivolumab infusion, without delay of more than 7 days with respect to the planned start of chemoradiation (RT-CT) among patients in the experimental arm And (3) with no radiotherapy break of one week or more, among patients in the experimental arm and patients in the control arm separately And (4) with minimal dose of radiotherapy (dose received >95% of theoretical dose) among patients in the experimental arm and patients in the control arm separately And (5) with minimal dose of chemotherapy of ≥200 mg/m² of cisplatin (CDDP) among patients in the experimental arm and patients in the control arm separately
Measured: Between baseline and until 3 months (at the end of chemoradiation)
Secondary outcomes (8)
The incidence of Adverse Events related or not related to chemoradiation and Nivolumab
Acute and delayed toxicities assessed according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0
Measured: During treatment phase and until 90 days after the last fraction of radiotherapy
Objective Response Rate in the experimental arm
Radiological response will be assessed according to RECIST 1.1.
Measured: Between baseline and up to 17 days after the second infusion of nivolumab
Tumor Response in both arms
Radiological response will be assessed according to RECIST 1.1.
Measured: Between baseline and 3 months after the end of chemoradiation
Overall Survival (OS)
the time from randomization to death from any cause
Measured: Between baseline and 2 years after the end of chemoradiation
Locoregional control (LRC)
the absence of disease progression (radiological progression according to RECIST 1.1 or clinical progression) or recurrence at the site of the primary tumor and loco-regional lymph nodes.
Measured: Between baseline and 2 years after the end of chemoradiation
Progression-Free Survival (PFS)
The time from randomization to progression or death from any cause
Measured: Between baseline and 2 years after the end of chemoradiation
Objective Response Rate in the experimental arm
Standardized uptake value (SUV) evolution will be assessed by positron emission tomography (PET)-scan.
Measured: Between baseline and up to 17 days after the second infusion of nivolumab
Tumor Response in both arms
SUV evolution will be assessed by PET-scan.
Measured: Between baseline and 3 months after the end of chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start25 Jul 2019
- Primary completion1 Apr 2022
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there are 2 arms: * Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7 * Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haïtham MIRGHANI, MD, PhD, Principal investigator, HOPITAL EUROPEEN GEORGES POMPIDOU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838263
- Sponsor's protocol ID
- UC-0130/1804
- Other IDs
- 2018-000626-60, 2018
- Acronym
- IMMUNEBOOST
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2019
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Publications
Mirghani H, Auperin A, Even C, Larive A, Fayette J, Geoffrois L, Clatot F, Calderon B, Tao Y, Nguyen F, Fabiano E, Kreps S, Gaultier AL, Bidault F, Puech J, Morin B, Picavet L, Tartour E, Ben Hariz A, Chevrot M, Monard L, Veyer D, Badoual C, Pere H, Blanchard P. Induction Nivolumab Before Chemoradiation in High-Risk Human Papillomavirus-Driven Oropharynx Cancers: IMMUNEBOOST-HPV, a Multicenter Randomized Phase II Trial. J Clin Oncol. 2026 Mar 20;44(9):787-800. doi: 10.1200/JCO-25-00835. Epub 2026 Jan 22.
PubMed 41570275
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer
- ClinicalTrials.gov ID
- NCT03838263
- Acronym / sponsor ID
- IMMUNEBOOST / UC-0130/1804
- Conditions
- Oropharynx Cancer
- Keywords
- Nivolumab, High-risk, HPV-driven oropharynx cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in "high risk" HPV-driven Oropharynx cancer
Detailed description
Methodology:
Patient screened wil be randomized 2:1 between 2 arms:
- Experimental arm: Nivolumab 2 infusions (2 weeks part) before standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7
- Control arm: Standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7
Primary Objective:
To assess the feasibility and tolerance of neoadjuvant nivolumab treatment before chemoradiation in "high-risk" HPV-driven Oropharynx Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, there are 2 arms: * Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7 * Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Nivolumab, Radiation: ChemoradiationExperimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7 |
| Control arm | Active comparator | Radiation: ChemoradiationControl arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥18 years old
- Histologically confirmed HPV-positive Oropharyngeal squamous cell carcinoma (OPSCC) amenable to curative treatment with RT-CT (HPV status is defined on the basis of the combination of 2 assays: p16 protein overexpression assessed by immunohistochemistry (IHC) and high-risk HPV DNA identification by in-situ Hybridization (ISH) or PCR. An HPV-driven OPSCC is defined as a tumor that is positive for both p16 IHC and HPV-DNA ISH or PCR)
- According to the 8th TNM edition, eligible stages are as follow:
- Planned date of chemoradiation allowing 2 treatment infusions, 2 weeks apart
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Key exclusion criteria (17 listed)
- Prior treatment for OPSCC
- Prior treatment with anti PD-1/PD-L1 and CTLA-4
- Distant metastases
- Tumour embolization within 28 days prior to the first dose of study drug.
- Contra-indication(s) to receive high-dose cisplatin as listed in the most updated Summary of Product Characteristics (including creatinine clearance <60 mL/min, pre-existing hearing loss or neurological disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: ANY2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation. | Drug | Experimental arm |
| ChemoradiationAlso: Radiation + cisplatinStandard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7 | Radiation | Control arm, Experimental arm |
Primary outcome
The rate of patients that fulfill the 3 or 5 conditions as described below (Feasibility assessment of nivolumab neoadjuvant treatment before chemoradiation)
Time frame: Between baseline and until 3 months (at the end of chemoradiation)
the rate of patients : (1) who can receive the 2 nivolumab infusions planned at D1 and between D14 to D16 among patients in the experimental arm And (2) who can receive chemoradiation at D30 (-2 /+7) after the second nivolumab infusion, without delay of more than 7 days with respect to the planned start of chemoradiation (RT-CT) among patients in the experimental arm And (3) with no radiotherapy break of one week or more, among patients in the experimental arm and patients in the control arm separately And (4) with minimal dose of radiotherapy (dose received >95% of theoretical dose) among patients in the experimental arm and patients in the control arm separately And (5) with minimal dose of chemotherapy of ≥200 mg/m² of cisplatin (CDDP) among patients in the experimental arm and patients in the control arm separately
8 secondary outcomes
The incidence of Adverse Events related or not related to chemoradiation and Nivolumab
Time frame: During treatment phase and until 90 days after the last fraction of radiotherapy
Objective Response Rate in the experimental arm
Time frame: Between baseline and up to 17 days after the second infusion of nivolumab
Tumor Response in both arms
Time frame: Between baseline and 3 months after the end of chemoradiation
Overall Survival (OS)
Time frame: Between baseline and 2 years after the end of chemoradiation
Locoregional control (LRC)
Time frame: Between baseline and 2 years after the end of chemoradiation
Progression-Free Survival (PFS)
Time frame: Between baseline and 2 years after the end of chemoradiation
Objective Response Rate in the experimental arm
Time frame: Between baseline and up to 17 days after the second infusion of nivolumab
Tumor Response in both arms
Time frame: Between baseline and 3 months after the end of chemoradiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 41570275Mirghani H, Auperin A, Even C, Larive A, Fayette J, Geoffrois L, Clatot F, Calderon B, Tao Y, Nguyen F, Fabiano E, Kreps S, Gaultier AL, Bidault F, Puech J, Morin B, Picavet L, Tartour E, Ben Hariz A, Chevrot M, Monard L, Veyer D, Badoual C, Pere H, Blanchard P. Induction Nivolumab Before Chemoradiation in High-Risk Human Papillomavirus-Driven Oropharynx Cancers: IMMUNEBOOST-HPV, a Multicenter Randomized Phase II Trial. J Clin Oncol. 2026 Mar 20;44(9):787-800. doi: 10.1200/JCO-25-00835. Epub 2026 Jan 22.
- Individual participant dataSharing planned: Yes. Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haïtham MIRGHANI, MD, PhD principal investigator
HOPITAL EUROPEEN GEORGES POMPIDOU
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Chemoradiation in people with Oropharynx Cancer, run by UNICANCER at 11 sites 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 22 inclusion and 17 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
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?
The rate of patients that fulfill the 3 or 5 conditions as described below (Feasibility assessment of nivolumab neoadjuvant treatment before chemoradiation) (time frame: Between baseline and until 3 months (at the end of chemoradiation)). 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 NCT03838263, 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 4 Mar 2025.