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A phase 3 trial of Bempegaldesleukin and Nivolumab in Melanoma, run by Bristol-Myers Squibb, completed.
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma is a phase 3 interventional study registered as NCT03635983 by Bristol-Myers Squibb, with 783 participants recorded, started 2018-09-21 and reaching its primary completion in 2021-11-19. Interventions recorded: NKTR-214, Nivolumab. Conditions recorded: Melanoma.
Linked to the drug Bempegaldesleukin because the registry names it among its interventions and Melanoma among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
783 enrolled.
95% CI 22.4 to 33.4; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication · 95% CI 30.3 to 42.0
Source95% CI 3.52 to 5.55; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication · 95% CI 4.14 to 7.82
Source95% CI 22.14 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-12-19), not from a publication · 95% CI 21.32 to NA
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)primary | Bempegaldesleukin + Nivolumab | 271 | 27.7% | - | 0.0311 | link |
| Nivolumab | 272 | 36% | ||||
| Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)primary | Bempegaldesleukin + Nivolumab | 391 | 4.17 months | 1.09 (0.89 to 1.33) | 0.3988 | link |
| Nivolumab | 392 | 4.99 months | ||||
| Overall Survival (OS)primary | Bempegaldesleukin + Nivolumab | 391 | 29.67 months | 0.94 (0.72 to 1.22) | 0.6361 | link |
| Nivolumab | 392 | 28.88 months |
Shares NKTR, Bempegaldesleukin, Nivolumab and the tag pipeline.
Shares Bempegaldesleukin, Nivolumab, Melanoma and the tag pipeline.
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Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Bristol Myers Squibb, Nivolumab and the tag pipeline.
Shares Bristol Myers Squibb, Nivolumab and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.
Shares Advanced melanoma (unresectable stage III and stage IV), Melanoma and the tag pipeline.