Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients W… (NCT03313206) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma
France60 participantsStarted 2018-05-28
Plain-language summary
The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be \>/= 18 years of age on day of signing informed consent.
✓. Present with a resectable head and neck mucosal melanoma.
✓. Be eligible for surgical treatment (without any contraindications).
✓. Be eligible for adjuvant radiotherapy.
✓. Have measurable disease based on RECIST 1.1.
✓. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
✓. Have a performance status of 0 or 1 on the ECOG Performance Scale.
Exclusion criteria
✕. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
✕. Has a metastatic disease.
✕. Has a non resectable melanoma.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (except topical or inhaled steroids) or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of trial treatment.
✕. Has a known history of active TB (Bacillus Tuberculosis)
✕. Hypersensitivity to pembrolizumab or any of its excipients.
✕. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to D1 of study treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
✕. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks or 5 half-life times (whatever the shorter) prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.