A study of bempegaldesleukin plus nivolumab versus nivolumab alone after surgical removal of all known Melanoma lesions in patients at high risk of cancer returning after surgery
- Conditions
- Resected Stage IIIA (lymph node metastasis > 1 mm)/B/C/D and IV melanoma with no evidence of diseaseMedDRA version: 21.1Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000917-34-DE
- Lead Sponsor
- ektar Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 950
Key Inclusion Criteria:
• Male or female patients, = 12 years of age at the time of signing the
informed consent form, except 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 [i.e., at
least one LN metastasis measuring > 1 mm at greatest diameter]),
IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th
edition) at study entry. Patients must be completely surgically resected
within 12 weeks prior to randomization. Patients with in-transit or
microsatellite disease will be allowed if disease has been completely
surgically resected. Patients must have been surgically rendered free of
disease with negative surgical margins documented, as applicable.
• Tumor tissue available from biopsy or resected disease must be
provided to central laboratory for biomarker and PD-L1 status analysis.
Must have PD-L1 expression classification (= 1%, < 1%, indeterminate,
or not evaluable) prior to randomization.
• Disease-free status documented by a complete physical examination
and imaging studies within 28 days prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 715
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Key Exclusion Criteria:
• 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 30 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 (Imlygic®),
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, such as
basal or squamous cell skin cancer, superficial bladder cancer, or
carcinoma in situ of the prostate, cervix, or breast. Consult with the
Medical Monitor about prior melanoma or other potential exceptions.
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