Phase 3
Completed N=783
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Melanoma
Source: ClinicalTrials.gov NCT03635983 ↗
Enrolled (actual)
783
Serious AEs
43.3%
Results posted
Dec 2022
Primary outcomePrimary: Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) — 27.7; 36.0 Percentage of participants — p=0.0311
◆ Published Evidence
Established
70citations · ~23 / year
Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.
Summary
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
Linked Publications (2)
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Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.
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Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) |
27.7; 36.0 | 0.0311 sig |
| PRIMARY Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) |
4.17; 4.99 | 0.3988 |
| PRIMARY Overall Survival (OS) |
29.67; 28.88 | 0.6361 |
| SECONDARY Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) |
56.1; 58.5 | — |
| SECONDARY Duration of Response (DoR) Per Blinded Independent Central Review (BICR) |
29.67; NA | — |
| SECONDARY Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) |
2.17; 2.20 | — |
| SECONDARY Objective Response Rate (ORR) Per Investigator |
29.2; 36.4 | 0.0626 |
| SECONDARY Progression-free Survival (PFS) Per Investigator |
4.27; 6.21 | 0.3713 |
| SECONDARY Clinical Benefit Rate (CBR) Per Investigator |
60.5; 61.8 | — |
| SECONDARY Duration of Response (DoR) Per Investigator |
NA; NA | — |
| SECONDARY Time to Objective Response (TTR) Per Investigator |
2.14; 2.14 | — |
| SECONDARY Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status |
17.6; 25.2; 36.4; 47.5 | 0.9939 |
| SECONDARY Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status |
3.25; 2.30; 6.24; 10.51 | — |
| SECONDARY Overall Survival (OS) by Baseline PD-L1 Status |
21.16; 21.13; NA; NA | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
378; 364; 351; 281; 132; 130 | — |
| SECONDARY Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline |
194; 173; 17; 22; 36; 41 | — |
Eligibility Criteria
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 apply
Data sourced from ClinicalTrials.gov (NCT03635983) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.