NCT03980314CompletedPhase 1
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma
Source: ClinicalTrials.gov · Last updated 15 Dec 2023
Brief summary (registry, in English)
The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 261 (actual)
- First submitted
- 6 Jun 2019
- Start date
- 24 Jun 2019
- Primary completion date
- 4 Mar 2021
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma
- NCT number
- NCT03980314
- EudraCT number
- 2018-002993-38
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 261
- From 24 Jun 2019 to the primary completion date, 4 Mar 2021
- 37 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined inclusion/exclusion criteria apply
Other illness
- Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
- Any significant acute or chronic medical illness that is uncontrolled
- History of ocular/uveal melanoma
- Active, known or suspected autoimmune disease
Who the study is looking for
- Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
- Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.