Clinical Trial TitleA Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
National Clinical Trial Number:NCT04410445
Clinical Trial Protocol Description:
The purpose of the study is to evaluate the effectiveness (how well the drug works), safety and tolerability of the investigational drug called bempegaldesleukin when combined with an approved drug called nivolumab in comparison with nivolumab alone after complete resection (removal of all sites of known disease) of melanoma in participants at high risk of cancer returning after surgery (recurrence).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female and 12 years of age or older at the time of signing the informed consent form. (Are 18 years of age or older where local regulations or institutional policies do not allow for patients < 18 years of age to participate.)
- Have histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.
- Have provided tumor tissue from biopsy or resected disease to central laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for stratification purposes.
- Have disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of ocular/uveal melanoma or mucosal melanoma.
- Have active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Have conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Have prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.