Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 7:24 AM
Study NCT ID:
NCT04052204
Status:
TERMINATED
Last Update Posted:
2021-10-14
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 1b/2 Study to Evaluate Safety and Clinical Activity of Avelumab in Combination With Bempegaldesleukin(NKTR-214) With or Without Talazoparib or Enzalutamide in Participants With Locally Advanced or Metastatic Solid Tumors
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study prematurely terminated as the experimental treatments evaluated in study B9991040 may not provide additional clinical benefit over current or future Standard of Care in the different therapeutic indications that this trial was to evaluate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or enzalutamide in metastatic castration resistant prostate cancer (mCRPC).
Detailed Description:
Phase 1b/ Phase 2 Design
Phase 1b will be the sequential dose-finding study.
Once the Phase 1b component is completed, Phase 2 will be initiated to further evaluate the safety and anti-tumor activity across combinations of therapy.
Combination A will enroll participants with SCCHN.
Combination B and C will enroll participants with mCRPC
Phase 1b will be the sequential dose-finding study.
Once the Phase 1b component is completed, Phase 2 will be initiated to further evaluate the safety and anti-tumor activity across combinations of therapy.
Combination A will enroll participants with SCCHN.
Combination B and C will enroll participants with mCRPC
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001358-24 | EUDRACT_NUMBER | None | View |