A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT05297565 Recruiting March 28, 2022 May 16, 2022

study description
Brief Summary

The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.

Condition or Disease: Melanoma
Intervention/treatment: Biological: Nivolumab/rHuPH20
Biological: Nivolumab
Phase: Phase 3
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 286 participants
Allocation : Randomized
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Estimated Study Start Date: May 2022
Estimated Primary Completion Date: December 2023
Estimated Study Completion Date: August 2026

Arms and interventions
Arm Intervention/treatment
Experimental: Part 1 Arm A: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20
Specified dose on specified days
Experimental: Part 2: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20
Specified dose on specified days
Active Comparator: Part 1 Arm B: Intravenous Nivolumab
Biological: Nivolumab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Time-averaged nivolumab serum concentration over the first 28 days (Cavgd28) [ Time Frame: Up to 28 days ]
2. Minimum nivolumab serum concentration at steady-state (Cminss) [ Time Frame: Up to 28 days ]
Secondary Outcome Measures: 1. Number of participants with adverse events (AEs) [ Time Frame: Up to 15 months ]
2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 15 months ]
3. Number of participants with treatment-related AEs [ Time Frame: Up to 15 months ]
4. Number of participants with immune-mediated adverse events (IMAEs) [ Time Frame: Up to 15 months ]
5. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 15 months ]
6. Number of participants with death [ Time Frame: Up to 15 months ]
7. Number of participants with laboratory abnormalities [ Time Frame: Up to 15 months ]
8. Recurrence-free survival (RFS) rates (per investigator) [ Time Frame: Up to 36 months ]
9. Overall survival (OS) rates [ Time Frame: Up to 36 months ]
10. Minimum nivolumab serum concentration on Day 28 (Cmind28) [ Time Frame: Up to 28 days ]
11. Maximum nivolumab serum concentration after the first dose (Cmax1) [ Time Frame: Up to 28 days ]
12. Time to maximum nivolumab serum concentration after the first dose (Tmax) [ Time Frame: Up to 28 days ]
13. Maximum nivolumab serum concentration at steady-state (Cmaxss) [ Time Frame: Up to 17 weeks ]
14. Time-averaged nivolumab serum concentration at steady-state (Cavgss) [ Time Frame: Up to 17 weeks ]
15. Minimum nivolumab serum concentration at steady-state (Cminss) [ Time Frame: Up to 17 weeks ]
16. Percentage of participants who develop anti-nivolumab antibodies [ Time Frame: Up to 15 months ]
17. Percentage of participants who develop neutralizing antibodies [ Time Frame: Up to 15 months ]
18. Percentage of participants with the impact of anti-nivolumab antibodies on AEs [ Time Frame: Up to 15 months ]
19. Percentage of participants with administration-related reactions [ Time Frame: Up to 15 months ]
20. Percentage of participants with events within MedDRA standardized MedDRA query (SMQ) anaphylactic reactions [ Time Frame: Up to 15 months ]
21. Mean Cancer Treatment Satisfaction Questionnaire (CTSQ) domain scores [ Time Frame: Up to 1 year ]
22. Mean CTSQ Satisfaction domain score change from baseline at each assessment time point [ Time Frame: Up to 1 year ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins Complete resection performed within 12 weeks prior to randomization or treatment assignment Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

History of uveal or mucosal melanoma Untreated/unresected CNS metastases or leptomeningeal metastases Active, known or suspected autoimmune disease Serious or uncontrolled medical disorder 4 weeks prior to screening Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible Prior immunotherapy treatments for any prior malignancies are not permitted

Other protocol-defined inclusion/exclusion criteria apply


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT # and Site #.

Locations
United States, Indiana Ft. Wayne Medical Oncology and Hematology Fort Wayne
Spain Local Institution - 0001 Barcelona
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05297565     
Other Study ID Numbers : CA209-6GE, 2021-003208-42, U1111-1266-6116
First Posted : March 28, 2022
Last Update Posted : May 16, 2022
Last Verified : May 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: Skin Cancer
rHuPH20
OPDIVO®
Additional relevant MeSH terms :
Neuroendocrine Tumors
Melanoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas