Ipilimumab and Nivolumab Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma
- Conditions
- Melanoma
- Registration Number
- NCT06566391
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria:<br><br> 1. Patients must have histologically or cytologically confirmed 8th ed. AJCC Stage<br> IIIB/C/D or Stage IV oligometastatic resectable melanoma. Patients with cutaneous,<br> mucosal, acral, ocular or unknown primary melanomas are eligible for enrollment.<br> Oligometastatic melanoma is defined as three or fewer areas of resectable disease<br> excluding central nervous system and bone involvement. In case of involvement of<br> three areas, one must be superficial (cutaneous-subcutaneous). Resectable tumors are<br> defined as having no significant vascular, neural or bony involvement. A<br> multidisciplinary discussion within surgical oncologists, medical oncologists, and<br> radiologist will assess if disease is resectable.<br><br> 2. Signed Written Informed Consent.<br><br> 3. Patients must be willing and able to comply with scheduled visits, treatment<br> schedule, laboratory tests and all protocol procedures.<br><br> 4. Males and Females, ages =18 years of age.<br><br> 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1<br><br> 6. Have measurable disease based on RECIST 1.1.<br><br> 7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a<br> tumor lesion at baseline and at the time points specified in the Study Procedure<br> Tables.<br><br> 8. Known BRAF V600 mutation status as determined by local institutional standard. All<br> BRAF statuses (BRAF wild type or BRAF 600 mutation positive) are eligible.<br><br> 9. Patients who have been previously treated in the adjuvant setting for melanoma will<br> be eligible for treatment after a 28 day washout period.<br><br> 10. Patients must be medically fit enough to undergo surgery as determined by the<br> treating medical and surgical oncology team.<br><br> 11. Demonstrate adequate organ function as defined below: Hematologic Absolute<br> neutrophil count (ANC) >/= 1.5 X 10^9/L; Hemoglobin >/= 9.5 g/dL Platelets >/= 100 X<br> 10^9/L PT/INR and PTT </= 1.5 X ULN. Hepatic Total bilirubin </= 1.5 X ULN (isolated<br> bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin<br> <35%) AST and ALT Albumin </= 2.5 X ULN 1 >/=2.5 g/dL Renal Creatinine OR Calculated<br> creatinine clearance OR 24-hour urine creatinine clearance </=1.5 X ULN 2 >/= 50<br> mL/min >/= 50 mL/min.<br><br> 12. Women are eligible to participate if: non-childbearing potential defined as<br> pre-menopausal females with a documented tubal ligation or hysterectomy; or<br> postmenopausal defined as months of spontaneous amenorrhea [in questionable cases a<br> blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and<br> estradiol < 40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement<br> therapy (HRT) and whose menopausal status is in doubt will be required to use one of<br> the contraception methods if they wish to continue their HRT during the study.<br> Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status<br> prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse<br> between the cessation of therapy and the blood draw; this interval depends on the<br> type and dosage of HRT.<br><br> 13. The individual methods of contraception and duration should be determined in<br> consultation with the investigator. Women of childbearing potential (WOCBP) must<br> have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or<br> equivalent units of HCG) within 24 hours prior to the start of investigational<br> product.<br><br> 14. Women must not be breastfeeding.<br><br> 15. Men who are sexually active must use any contraceptive method with a failure rate of<br> less than 1% per year. The investigator shall review contraception methods and the<br> time period that contraception must be followed.<br><br> 16. Women who are not of childbearing potential (i.e., who are postmenopausal or<br> surgically sterile) and azoospermic men do not require contraception<br><br>Exclusion Criteria:<br><br> 1. Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy,<br> or biologic therapy) or investigational anti-cancer drug.<br><br> 2. Any major surgery within the last 3 weeks.<br><br> 3. Brain metastases, leptomeningeal disease or bone metastases.<br><br> 4. Pregnant or lactating female.<br><br> 5. Unwillingness or inability to follow the procedures required in the protocol.<br><br> 6. Any serious or uncontrolled medical disorder that, in the opinion of the<br> investigator, may increase the risk associated with study participation or study<br> drug administration, impair the ability of the subject to receive protocol therapy,<br> or interfere with the interpretation of study results.<br><br> 7. Prior malignancy active within the previous 2 years except for patient's prior<br> diagnosis of melanoma and locally curable cancers that have been apparently cured,<br> such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma<br> in situ of the prostate, cervix, or breast with local control measures (surgery,<br> radiation).<br><br> 8. Patients with active, known or suspected autoimmune disease. Patients with vitiligo,<br> type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only<br> requiring hormone replacement, psoriasis not requiring systemic treatment, or<br> conditions not expected to recur in the absence of an external trigger are permitted<br> to enroll.<br><br> 9. Patients with a condition requiring systemic treatment with either corticosteroids<br> (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within<br> 14 days of study drug administration. Inhaled or topical steroids and adrenal<br> replacement doses > 10 mg daily prednisone equivalents are permitted in the absence<br> of active autoimmune disease.<br><br> 10. Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.<br><br> 11. Any positive test result for hepatitis B or C virus indicating acute or chronic<br> infection.<br><br> 12. Known history of testing positive for human immunodeficiency virus or known acquired<br> immunodeficiency syndrome.<br><br> 13. History of severe hypersensitivity reaction to any monoclonal antibody.<br><br> 14. Prisoners or patients who are involuntarily incarcerated.<br><br> 15. Patients who are compulsorily detained for treatment of either a psychiatric or<br> physical (infection disease) illness.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of pathological complete response (Efficacy)
- Secondary Outcome Measures
Name Time Method Rates of 3-4 AEs;Overall AE rates;Patients completing treatment schedule.;Overall Response Rate (ORR);Overall Survival (OS)