Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

Stopped early · Phase 3

Conditions studied: Melanoma, Melanoma Stage III, Melanoma Stage IV, Melanoma (Skin)

In brief

The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

Key facts

Study ID

NCT04410445

Run by

Nektar Therapeutics

People needed

765

Starts

2020-07-27

Expected to finish

2022-09-22

Last updated by the study team

2023-04-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients, age 12 years or older at the time of signing the informed consent form (age 18 years or older where local regulations, countries, and/or institutional policies do not allow for patients < 18 years of age (adolescents) to participate). In regions where adolescents are not allowed to participate in the study due to age restrictions, enrolled patients must be ≥ 18 years of age.
• 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.
• Tumor tissue available from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for stratification purposes.
• Disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.

You may not qualify if…

• History of ocular/uveal melanoma or mucosal melanoma.
• 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.
• 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.
• Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
• Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2 (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways).
• Prior malignancy active within the previous 3 years except for locally potentially curable cancers that have been apparently cured.

Where it is running

• Banner MD Anderson Cancer Center — Little Rock, Arkansas, United States
• Kaiser Foundation Hospital, Inpatient Pharmacy — Anaheim, California, United States
• Kaiser Permanente — Fontana, California, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Hematology Oncology Medical Group of Orange County, Inc. — Orange, California, United States
• University of California Irvine — Orange, California, United States
• Emad Ibrahim, MD, Inc — Redlands, California, United States
• Kaiser Permanente — Riverside, California, United States
• Southern California Permanente Medical Group — Riverside, California, United States
• San Francisco Oncology Associates — San Francisco, California, United States
• California Cancer Associates for Research and Excellence — San Marcos, California, United States
• Kaiser Permanente — San Marcos, California, United States
• Angeles Clinic and Research Institute — Santa Monica, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Rocky Mountain Cancer Centers (Littleton) - USOR — Aurora, Colorado, United States
• University of Colorado - Cancer Center - PPDS — Aurora, Colorado, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Orlando Health Cancer Institute — Longwood, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Goshen Center For Cancer Care — Goshen, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic - PIN — Rochester, Minnesota, United States
• Honor Health — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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