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Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma | Clinical Trials | Clareo Health

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Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma

Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma

NCT03313206•Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be willing and able to provide written informed consent/assent for the trial.
•2. Be \>/= 18 years of age on day of signing informed consent.
•3. Present with a resectable head and neck mucosal melanoma.
•4. Be eligible for surgical treatment (without any contraindications).
•5. Be eligible for adjuvant radiotherapy.
•6. Have measurable disease based on RECIST 1.1.
•7. 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.
•8. Have a performance status of 0 or 1 on the ECOG Performance Scale.
•9. Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 10 days of treatment initiation.
•10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
+5 more criteria

Exclusion Criteria

•1. 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.
•2. Has a metastatic disease.
•3. Has a non resectable melanoma.
•4. 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.
•5. Has a known history of active TB (Bacillus Tuberculosis)
•6. Hypersensitivity to pembrolizumab or any of its excipients.
•7. 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.
•8. 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.
•* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
+28 more criteria

Locations (1)

Gustave Roussy

Villejuif, Val De Marne, France

Key Dates

Start Date

May 28, 2018

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2029

Last Updated

January 20, 2026

Enrollment

ESTIMATED participants

Conditions

Head and Neck Mucosal Melanomas

Interventions

Pembrolizumab

DRUG

Surgery

PROCEDURE

IMRT

RADIATION

Lenvatinib

DRUG