NKTR-214
BRISTOL MYERS SQUIBB CO BMY CELG-RI · Melanoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- BRISTOL MYERS SQUIBB CO BMY CELG-RI Source: Company record for BRISTOL MYERS SQUIBB CO (opens in a new tab)
- Indication
- Melanoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 21 Sep 20181 linked trial
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for NKTR-214. Editors add each one with its source.
Filed application
No filed application is on record for NKTR-214. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for NKTR-214.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03635983ClinicalTrials.gov record for NCT03635983 (opens in a new tab) | A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma | Phase 3 | Completed | 783 (actual) | 19 Nov 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03635983 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03635983
Serious adverse events (Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months).): Bempegaldesleukin + Nivolumab 161 of 388; Nivolumab 172 of 382 Source: ClinicalTrials.gov results for NCT03635983 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03635983 (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as NKTR-214.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT03635983 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.