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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

Primary Purpose

Melanoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Hartford Hospital
  • Virginia Piper Cancer Institute
  • Local Institution - 0035
  • University of Pittsburgh Medical Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0041
  • Cross Cancer Institute
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0032
  • ASST Papa Giovanni XXIII
  • Istituto Oncologico Veneto IOV
  • Local Institution - 0016
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Nova Clin Medical Research Center
  • Local Institution
  • Hospital Gral. Univ. Gregorio Maranon
  • Fundacion Jimenez Diaz
  • Local Institution - 0028

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (Process C)

Arm B (Process D)

Arm Description

Outcomes

Primary Outcome Measures

Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)
Observed serum concentration at the end of a dosing interval (Ctau)
Time of maximum observed plasma concentration (Tmax)
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Adverse Events leading to Discontinuation
Number of Participants With Adverse Events (AEs)
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of Participants with AEs leading to death

Full Information

First Posted
June 6, 2019
Last Updated
May 12, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03980314
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Process C)
Arm Type
Active Comparator
Arm Title
Arm B (Process D)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Over the dosing interval at Week 1 and Week 17
Title
Observed serum concentration at the end of a dosing interval (Ctau)
Time Frame
Over the dosing interval at Week 1 and Week 17
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Over the dosing interval at Week 1 and Week 17
Title
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Time Frame
Through Week 51 Day 1
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Up to 65 weeks
Title
Number of Participants With Adverse Events leading to Discontinuation
Time Frame
Up to 65 weeks
Title
Number of Participants With Adverse Events (AEs)
Time Frame
Up to 65 weeks
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame
Up to 65 weeks
Title
Number of Participants with AEs leading to death
Time Frame
Up to 65 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Local Institution - 0035
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution
City
Wollstonecraft
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution
City
Cerqueira Cesar
State/Province
SAO Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution
City
Sao Jose Do Rio Preto
State/Province
SAO Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Local Institution - 0041
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6X 1E8
Country
Canada
Facility Name
Local Institution
City
Santiago de Chile
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Local Institution
City
Santiago
Country
Chile
Facility Name
Local Institution
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Local Institution
City
Wilton
State/Province
Cork
ZIP/Postal Code
T12 DC4A
Country
Ireland
Facility Name
Local Institution - 0032
City
Dublin
Country
Ireland
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0016
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
San Pedro Garza Garcia
State/Province
Nuevo LEON
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Local Institution
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Local Institution
City
Christchurch
Country
New Zealand
Facility Name
Local Institution
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Nova Clin Medical Research Center
City
Timisoara
ZIP/Postal Code
300696
Country
Romania
Facility Name
Local Institution
City
Badalona-barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 0028
City
Malaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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