NCT04052204

Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	avelumab	Investigational fully human anti-PD-L1 monoclonal antibody
DRUG	Bempegaldesleukin	Investigational CD122-biased cytokine agonist
DRUG	talazoparib	poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor
DRUG	enzalutamide	androgen receptor inhibitor

Timeline

• Start date: 2019-12-30
• Primary completion: 2020-09-29
• Completion: 2020-09-29
• First posted: 2019-08-09
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

5 sites across 4 countries: United States, Belgium, Poland, Spain

Regulatory

• FDA-regulated drug study