Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03980314




Registration number
NCT03980314
Ethics application status
Date submitted
6/06/2019
Date registered
10/06/2019
Date last updated
15/12/2023

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2018-002993-38
Secondary ID [2] 0 0
CA209-8FC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab

Active Comparator: Arm A (Process C) -

Experimental: Arm B (Process D) -


Treatment: Drugs: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
Timepoint [1] 0 0
Over the dosing interval at Week 1 and Week 17
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
Over the dosing interval at Week 1 and Week 17
Secondary outcome [2] 0 0
Observed serum concentration at the end of a dosing interval (Ctau)
Timepoint [2] 0 0
Over the dosing interval at Week 1 and Week 17
Secondary outcome [3] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [3] 0 0
Over the dosing interval at Week 1 and Week 17
Secondary outcome [4] 0 0
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Timepoint [4] 0 0
Through Week 51 Day 1
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Up to 65 weeks
Secondary outcome [6] 0 0
Number of Participants With Adverse Events leading to Discontinuation
Timepoint [6] 0 0
Up to 65 weeks
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [7] 0 0
Up to 65 weeks
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities
Timepoint [8] 0 0
Up to 65 weeks
Secondary outcome [9] 0 0
Number of Participants with AEs leading to death
Timepoint [9] 0 0
Up to 65 weeks

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2023
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Local Institution - 0001 - Wollstonecraft
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Brazil
State/province [6] 0 0
RIO Grande DO SUL
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Brazil
State/province [8] 0 0
SAO Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio de Janeiro
Country [11] 0 0
Canada
State/province [11] 0 0
Edmonton
Country [12] 0 0
Chile
State/province [12] 0 0
Metropolitana
Country [13] 0 0
Chile
State/province [13] 0 0
Santiago
Country [14] 0 0
France
State/province [14] 0 0
Marseille Cedex 5
Country [15] 0 0
France
State/province [15] 0 0
Nantes Cedex 1
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
Ireland
State/province [17] 0 0
Cork
Country [18] 0 0
Ireland
State/province [18] 0 0
Dublin
Country [19] 0 0
Italy
State/province [19] 0 0
Bergamo
Country [20] 0 0
Italy
State/province [20] 0 0
Padova
Country [21] 0 0
Italy
State/province [21] 0 0
Siena
Country [22] 0 0
Mexico
State/province [22] 0 0
Distrito Federal
Country [23] 0 0
Mexico
State/province [23] 0 0
Nuevo Leon
Country [24] 0 0
Mexico
State/province [24] 0 0
Nuevo LEON
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
New Zealand
State/province [26] 0 0
Christchurch
Country [27] 0 0
New Zealand
State/province [27] 0 0
Wellington
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Romania
State/province [29] 0 0
Timisoara
Country [30] 0 0
Spain
State/province [30] 0 0
Badalona-barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
Malaga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03980314
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03980314