NCT04084951

Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SQZ Biotechnologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in HLA-A\*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Conditions

• Adult Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	SQZ-PBMC-HPV	antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16
DRUG	Atezolizumab	programmed cell death ligand 1 (PD-L1) blocking antibody
DRUG	Ipilimumab	cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
DRUG	Nivolumab	programmed cell death 1 (PD-1) blocking antibody

Timeline

• Start date: 2020-01-28
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2019-09-10
• Last updated: 2023-04-14

Locations

12 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated drug study