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Phase 1

• Conditions: High risk Human Papilloma Virus (HPV)-driven oropharynx cancer patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000626-60-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

1. Age = 18 years old
2. Histologically confirmed HPV-positive 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) orPCR. An HPV-driven OPSCC is defined as a tumor that is positive for both p16 IHC and HPV-DNA ISH or PCR)
3. 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)
4. Planned date of chemoradiation allowing 2 Nivolumab infusions, 2 weeks apart.
5. ECOG performance status =1
6 Adequate cardiac, haematological, hepatic and renal function allowing treatment with cisplatin and nivolumab
7. 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.
8. Women of childbearing potential must have a negative serum or urine pregnancy test done within 72 hours before randomisation.
9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures (including mandatory study-specific biopsies)
10. Subjects must have at least one lesion amenable to biopsy.
11. Consent to provide archived tumor tissue sample, if available.
12. Patients must be affiliated to a Social Security System.
13. Patient information and written informed consent form signed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Prior treatment for OPSCC
2. Prior treatment with anti-PD-1/PD-L1 and CTLA-4
3. Distant metastases
4. Tumor embolization within 28 days prior to the randomisation
5. Contra-indication to receive high-dose cisplatin
6. 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.
7. Current or prior use of immunosuppressive medication within 14 days before randomisation, including intranasal and inhaled corticosteroids or systemic corticosteroids.
8. Active or prior documented autoimmune or inflammatory disease within the 2 years prior to randomisation (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).
9. History of primary immunodeficiency or organ transplant requiring immunosuppressive drugs
10. Patients with a known HIV, active hepatitis B or C infection.
11. Other invasive malignancy within 3 years of randomisation 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.
12. Pregnant women or women who are breast-feeding.
13. 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.
14. Individuals deprived of liberty or placed under the authority of a tutor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified