Phase II multicentric study: efficacy evaluation of neo-adjuvant treatment associated with maintenance therapy by anti-PD1 immunotherapy on disease-free-survival (DFS) in patients with resectable mucosal melanoma
- Conditions
- Resectable mucosal melanomasMedDRA version: 21.1Level: LLTClassification code: 10053571Term: Melanoma Class: 10029104Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-513027-16-00
- Lead Sponsor
- Institut Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Be willing and able to provide written informed consent/assent for the trial., 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., 11. 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., 12. 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., 13. Patient affiliated to a social security system or beneficiary of the same, 14. Not having any contraindication for lenvatinib treatment, 2. Be >18 years of age on day of signing informed consent., 3. Present with a resectable 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.
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., 10. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability., 11. Has active autoimmune and/or immune mediated inflammatory disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment., 12. Has known history of, or any evidence of active, non-infectious pneumonitis., 13. Has an active infection requiring systemic therapy., 14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator., 15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial., 16. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment., 17. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent., 18. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)., 19. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)., 2. Has a metastatic disease., 20. Has received a live vaccine within 30 days of planned start of study therapy., 21. Major injuries and/or surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing, 22. Has a prior history of organ transplant including allogeneic stem cell transplant, 23. Has a LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO), 24. Has an uveal melanoma, For the cohort B, patients must be excluded if one of the following additional criteria is met : 25. Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication, 26. Electrolyte abnormalities that have not been corrected, 27. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 12 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening, 28. Bleeding or thrombotic disorders or subjects at risk for severe he
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method