MelanomaPhase 1NCT03980314
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 Phase 1 study testing Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 37 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 37 sitesin 14 countries
- Study dates
- 24 Jun 2019to 6 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
37 sites in 14 countries.
37 sites in 14 countries
Brazil6 sites
Local Institution - 0039
Barretos, São Paulo, 14780-070
Local Institution - 0038
Cerqueira César, São Paulo, 01246-000
Local Institution - 0036
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0037
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution - 0041
Rio de Janeiro, 20230-130
Local Institution - 0040
São José do Rio Preto, São Paulo, 15090000
United States4 sites
Local Institution - 0035
Charlotte, North Carolina, 28204
Local Institution - 0006
Hartford, Connecticut, 06106
Local Institution - 0008
Minneapolis, Minnesota, 55407
Local Institution - 0043
Pittsburgh, Pennsylvania, 15213
Chile4 sites
Local Institution - 0024
Independencia, Santiago Metropolitan
Local Institution - 0045
Santiago, Santiago Metropolitan, 8420383
Local Institution - 0023
Santiago, Santiago Metropolitan
Local Institution - 0022
Santiago, 0
Spain4 sites
Local Institution - 0029
Badalona-barcelona, 08916
Local Institution - 0026
Madrid, 28007
Local Institution - 0027
Madrid, 28040
Local Institution - 0028
Málaga, 29010
France3 sites
Local Institution - 0009
Marseille, 13385
Local Institution - 0010
Nantes, 44093
Local Institution - 0011
Paris, 75475
Italy3 sites
Local Institution - 0014
Bergamo, 24127
Local Institution - 0015
Padova, 35128
Local Institution - 0016
Siena, 53100
Mexico3 sites
Local Institution - 0033
Monterrey, Nuevo León, 64460
Local Institution - 0031
San Pedro Garza García, Nuevo León, 66278
Local Institution - 0034
Tlalpan, Mexico City, 14080
New Zealand3 sites
Local Institution - 0005
Auckland, 1023
Local Institution - 0004
Christchurch, 0
Local Institution - 0003
Wellington, 6021
Ireland2 sites
Local Institution - 0032
Dublin
Local Institution - 0018
Wilton, CORK, T12 DC4A
Australia1 site
Local Institution - 0001
Wollstonecraft, New South Wales, 2065
About this study
Official title: 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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Process C) | Active comparator | Not described Receives: Drug: Nivolumab |
| Arm B (Process D) | Experimental | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
Measured: Over the dosing interval at Week 1 and Week 17
Secondary outcomes (9)
Maximum Observed Plasma Concentration (Cmax)
Measured: Over the dosing interval at Week 1 and Week 17
Observed serum concentration at the end of a dosing interval (Ctau)
Measured: Over the dosing interval at Week 1 and Week 17
Time of maximum observed plasma concentration (Tmax)
Measured: Over the dosing interval at Week 1 and Week 17
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Measured: Through Week 51 Day 1
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to 65 weeks
Number of Participants With Adverse Events leading to Discontinuation
Measured: Up to 65 weeks
Number of Participants With Adverse Events (AEs)
Measured: Up to 65 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: Up to 65 weeks
Number of Participants with AEs leading to death
Measured: Up to 65 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start24 Jun 2019
- Primary completion4 Mar 2021
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980314
- Sponsor's protocol ID
- CA209-8FC
- Other IDs
- 2018-002993-38, 2018
- Status last verified
- Dec 2023
- First submitted
- 6 Jun 2019
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03980314
- Acronym / sponsor ID
- CA209-8FC
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Process C) | Active comparator | Drug: Nivolumab |
| Arm B (Process D) | Experimental | Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Drug | Arm A (Process C), Arm B (Process D) |
Primary outcome
Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
Time frame: Over the dosing interval at Week 1 and Week 17
9 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Over the dosing interval at Week 1 and Week 17
Observed serum concentration at the end of a dosing interval (Ctau)
Time frame: Over the dosing interval at Week 1 and Week 17
Time of maximum observed plasma concentration (Tmax)
Time frame: Over the dosing interval at Week 1 and Week 17
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Time frame: Through Week 51 Day 1
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 65 weeks
Number of Participants With Adverse Events leading to Discontinuation
Time frame: Up to 65 weeks
Number of Participants With Adverse Events (AEs)
Time frame: Up to 65 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 65 weeks
Number of Participants with AEs leading to death
Time frame: Up to 65 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
37 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 37 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Brazil, United States, Chile, Spain, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h) (time frame: Over the dosing interval at Week 1 and Week 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.