Description:
The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative
to Process C.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CA209-8FC
- SECONDARY ID:
2018-002993-38
- NCT ID:
NCT03980314
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | Opdivo | Arm A (Process C) |
Purpose
The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative
to Process C.
Detailed Description
The study is intended to compare the pharmacokinetic of Process D nivolumab to Process C
nivolumab administered after complete resection of Stage IIIa/b/c/d or Stage IV melanoma.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A (Process C) | Experimental | Participants will receive nivolumab specified dose on specified days" | |
| Arm B (Process D) | Experimental | Participants will receive nivolumab specified dose on specified days" | |
Eligibility Criteria
Inclusion Criteria:
- Late Stage melanoma that is completely surgically resected and pathologically absent
- Participants must not have received anti-cancer therapy greater than equal to (>=) 6
months prior to randomization
- Imaging studies to include Computed tomography (CT), Magnetic resonance imaging (MRI),
positron emission tomography (PET) scans that show no clinically detectable nodes on
imaging
Exclusion Criteria:
- Participants must not have a history of ocular/uveal melanoma
- Participants with active, known, or suspected autoimmune disease(s) not requiring
systemic treatment, or conditions not expected to recur in the absence of an external
trigger are permitted to enroll
- Participants must not have prior malignancy active within the previous 3 years except
for locally curable cancers
- Participants must not have a condition requiring systemic treatment with either
corticosteroids or other immunosuppressive medications within 14 days of study drug
administration.
- Participants must not have had prior therapy for melanoma except surgery, for the
melanoma lesion(s) adjuvant radiation therapy after neurosurgical resection for CNS
lesions and except for participants who received prior adjuvant interferon therapy
- Treatment directed against the resected melanoma that is administered after complete
resection other than adjuvant radiation
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Area under the concentration-time curve in one dosing interval (336 h) |
| Time Frame: | Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Maximum Observed Plasma Concentration (Cmax) |
| Time Frame: | Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 |
| Safety Issue: | |
| Description: | |
| Measure: | Trough Observed Serum Concentration (Ctrough) |
| Time Frame: | Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 |
| Safety Issue: | |
| Description: | |
| Measure: | Volume of Distribution |
| Time Frame: | Predose (0 hour), 0.5 and 4 hours post dose relative to Week 1 and Week 17 of Day 1 |
| Safety Issue: | |
| Description: | |
| Measure: | Total Body Clearance |
| Time Frame: | At Week 17 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) |
| Time Frame: | Predose (0 hr), Week 1, 3, 17, 19, 35, and 51 of Day 1 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants With Serious Adverse Events (SAEs) and Deaths |
| Time Frame: | Up to Week 51 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants With Adverse Events leading to Discontinuation |
| Time Frame: | Up to Week 51 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants With Adverse Events (AEs) |
| Time Frame: | Up to Week 51 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants With Clinically Significant Laboratory Abnormalities |
| Time Frame: | Up to Week 51 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 23, 2021
