Description:
The purpose of the study is to test the effectiveness (how well the drug works), safety, and
tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
nivolumab given alone in participants with previously untreated melanoma skin cancer that is
either unable to be surgically removed or has spread
Title
- Brief Title: A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
- Official Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Clinical Trial IDs
- ORG STUDY ID:
CA045-001
- SECONDARY ID:
2018-001423-40
- SECONDARY ID:
17-214-08
- NCT ID:
NCT03635983
Conditions
Interventions
Drug | Synonyms | Arms |
---|
NKTR-214 | Bempegaldesleukin, BMS-986321 | Combination |
Nivolumab | Opdivo, BMS-936558 | Combination |
Purpose
The purpose of the study is to test the effectiveness (how well the drug works), safety, and
tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
nivolumab given alone in participants with previously untreated melanoma skin cancer that is
either unable to be surgically removed or has spread
Trial Arms
Name | Type | Description | Interventions |
---|
Combination | Experimental | NKTR-214 + Nivolumab | |
Monotherapy | Experimental | Nivolumab | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or
older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
- Histologically confirmed stage III (unresectable) or stage IV melanoma
- Treatment-naive participants (ie, no prior systemic anticancer therapy for
unresectable or metastatic melanoma) with the exception of prior adjuvant and/or
neoadjuvant treatment for melanoma with approved agents
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Uveal melanoma
- Participants with an active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate (ORR) by Blinded Independent Central Review (BICR) |
Time Frame: | Approximately 16 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Clinical benefit rate (CBR) |
Time Frame: | Approximately 16 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DoR) |
Time Frame: | Approximately 16 months |
Safety Issue: | |
Description: | |
Measure: | Time to response (TTR) |
Time Frame: | Approximately 16 months |
Safety Issue: | |
Description: | |
Measure: | ORR by investigator and in biomarker population |
Time Frame: | Approximately 16 months |
Safety Issue: | |
Description: | |
Measure: | PFS by investigator and in biomarker population |
Time Frame: | Approximately 22 months |
Safety Issue: | |
Description: | |
Measure: | OS in biomarker population |
Time Frame: | Up to 59 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of participants with non-serious Adverse Events (AEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of participants with Serious Adverse Events (SAEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of treatment-related AEs |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of treatment-related SAEs |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities in blood |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities in blood serum |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities in urine |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- NKTR-214
- Nivolumab
- Immunotherapy
- bempegaldesleukin (BEMPEG: NKTR-214)
Last Updated
November 17, 2020