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

Who is this study for? Patients with Mucosal Melanoma of the Head and Neck
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 10 days of treatment initiation.

⁃ 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.

⁃ Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

⁃ Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

⁃ Patient affiliated to a social security system or beneficiary of the same

⁃ For the cohort B, patients must met the following additional criteria :

⁃ Not having any contraindication for lenvatinib treatment

Locations
Other Locations
France
Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Antoine MOYA PLANA, MD
antoine.moya-plana@gustaveroussy.fr
+33 (0)1 42 11 45 06
Backup
Aline MAILLARD
aline.maillard@gustaveroussy.fr
+33 (0)1 42 11 41 36
Time Frame
Start Date: 2018-05-28
Estimated Completion Date: 2028-05
Participants
Target number of participants: 60
Treatments
Experimental: Cohort A
The cohort A (Pembrolizumab only) will be opened in a first study step. Anti-PD1 antibody will be used (pembrolizumab, Merck®) intravenously at a dose of 200 mg every 3 weeks (4 injections maximum over 12 weeks), monotherapy
Experimental: Cohort B
Up to 26 evaluable patients will be treated in the cohort B (Pembrolizumab with Lenvatinib) if they do not have any contraindication for receiving lenvatinib treatment, otherwise they will be treated in the cohort A if slots are available. In the cohort B, the neo-adjuvant anti-PD1 immunotherapy will be combined with orally lenvatinib at a daily dose of 20 mg for 6 weeks started on the day of the first anti-PD1 dose.
Related Therapeutic Areas
Sponsors
Leads: Gustave Roussy, Cancer Campus, Grand Paris

This content was sourced from clinicaltrials.gov

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