Status:
RECRUITING
Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
GORTEC
National Cancer Institute, France
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers
Detailed Description
Comparative interventional prospective phase 3, randomised, open-label, multicentric trial comparing the combination of radiotherapy and pembrolizumab alone or with chemotherapy to systemic treatment ...
Eligibility Criteria
Inclusion
- Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
- Histologically confirmed squamous cell carcinoma of head and neck (oral cavity, oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological confirmation is required in case of a single metastatic lesion.
- Eligible for treatment by pembrolizumab according to the European Marketing Authorization
- Patient ≥18 years old
- Performance status: 0-1 (WHO)
- Combined Positive Score (CPS) ≥1 for primary tumor (as determined per local practice)
- Subjects must have at least one measurable lesion as per RECIST v1.1 to assess efficacy
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization:
- a. If randomization is done before treatment start: i. Absolute neutrophil count ≥1.5 × 10⁹/L ii. Platelet ≥100 × 10⁹/L iii. Hemoglobin ≥90 g/L iv. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), ≤3 × upper limit of normal (ULN), (unless documented liver metastases where ≤5 x ULN is permitted) v. Bilirubin ≤1.5 × ULN. vi. Serum albumin ≥25 g/L vii. Creatinine clearance ≥30 mL/min (calculated per institutional guidelines or by Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula) viii. Corrected serum calcium of ≤11.5 mg/dL or ≤2.6 mmol/L. b. If randomization if done after treatment start i. Absolute neutrophil count ≥1.0 × 10⁹/L ii. Platelet ≥75 × 10⁹/L iii. Hemoglobin ≥85 g/L
- Patient must agree to use adequate contraception methods for the duration of the study treatment and up to 4 months after the last dose of pembrolizumab administration
- Patients must be affiliated to a Social Security System (or equivalent)
- No disease progression during systemic treatment if the randomization is done after the start of pembrolizumab for the current disease
Exclusion
- Symptomatic central nervous system (CNS) metastases and / or carcinomatous meningitis
- History of another malignancy within 2 years prior to study inclusion, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma
- Prior radiotherapy in the head and neck region
- Any prior or current non-surgical treatment for invasive head and neck cancer. (except for pembrolizumab +/- chemotherapy for the current cancer for a maximum of 6 cycles). This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, chemotherapy, anti-PD-1/PD-L1 and CTLA-4, prior radiotherapy (RT), or use of any investigational agent. Loco-regional recurrent or second primary head and neck cancer after prior surgical treatment alone in the head and neck region could be eligible.
- Known Acquired Immune Deficiency Syndrome (AIDS)
- Known currently active infection including hepatitis B or hepatitis C
- Patient having received live attenuated vaccine within 28 days prior to enrolment
- Pregnant or breast feeding woman
- Active autoimmune disease except vitiligo, type-1 diabetes, hypothyroid stabilized with hormonal substitution, or psoriasis which do not require systemic treatment
- Active immunodeficiency or ongoing immunosuppressive therapy
- Active symptomatic interstitial lung disease
- 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
- Any social, personal, medical, geographic and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent
- Prior organ transplantation including allogenic stem-cell transplantation
- Other severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis or psychiatric conditions including active suicidal ideation; or laboratory abnormalities that may increase the risk associated with study participation and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Person deprived of their liberty or under protective custody or guardianship
- Patient who have taken any investigational medicinal product or have used an investigational device within 30 days prior to study inclusion
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04747054
Start Date
December 1 2021
End Date
October 1 2029
Last Update
October 26 2024
Active Locations (26)
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1
Institut Sainte Catherine
Avignon, France, 84000
2
CHU Jean Minjoz
Besançon, France, 25030
3
CHU Bordeaux
Bordeaux, France, 33075
4
Institut Bergonié
Bordeaux, France