A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB/C, Stage III, or Stage IV Melanoma
Study Identifier:
BIO-NIVOLU-103
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To compare the Bmab1700 with Opdivo® in participants who have undergone complete surgical resection of Stage IIB/C, Stage III, or Stage IV melanoma.
To study pharmacokinetics, safety, and immunogenicity comparison of Bmab1700 and Opdivo as adjuvant monotherapy in patients with melanoma
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Melanoma
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- 1. Participants greater than or equal to (>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is >18 years old). 2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed. 3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports. 4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization. 5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.
Exclusion criteria
- 1. History of ocular/uveal melanoma. 2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded. 3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. 4. Participants with a condition requiring systemic treatment with either corticosteroids >10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses <=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease 5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention. 6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0). 7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion). 8. Participants who have received a live/attenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. 9. Expected to receive any other form of antineoplastic therapy during the clinical study. 10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation/ checkpoint pathways. 11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care. 12. Participants will be excluded if pre randomization clinical or laboratory assessments demonstrate clinically significant hematologic abnormalities, impaired renal function (CrCl or GFR less than or equal to 40 mL/min), or hepatic dysfunction (AST or ALT more than 2.5*ULN or total bilirubin more than 1.5*ULN, except for participants with Gilbert syndrome with total bilirubin less than 3*ULN), as defined by the laboratory cut off values specified in the clinical protocol. 13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection. 14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative). 15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram [ECG] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator. 16. Known history of allergy or hypersensitivity to IMP components. 17. Known history of severe hypersensitivity reaction (Grade >=3) to any monoclonal antibody. 18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 19. Has documented or known current alcohol/drug abuse that precludes the participant's ability to adhere to the protocol. 20. Prisoners or participants who are involuntarily incarcerated.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Manuel Pedregal Trujillo
Status
Recruiting
Condition(s) Treated at Site
Melanoma