Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084951
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
SQZ Biotechnologies

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors.

Condition or disease Intervention/treatment Phase
Adult Solid Tumor Biological: SQZ-PBMC-HPV Drug: Atezolizumab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Semi-sequential enrollment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dose escalation of SQZ-PBMC-HPV
In the monotherapy escalation cohorts, SQZ-PBMC-HPV is given for up to 3 administrations at intervals of 3 weeks as a low and a high cell dose. In addition, a second low cell dose cohort will test the impact of additional vaccination boosts of SQZ-PBMC-HPV.
 Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of autologous peripheral blood mononuclear cells (PBMCs) presenting immunogenic epitopes of the E6 and E7 proteins of HPV16
Experimental: Dose escalation of SQZ-PBMC-HPV + atezolizumab
In the combination escalation cohorts, SQZ-PBMC-HPV in combination with atezolizumab is given for up to 3 administrations at intervals of 3 weeks as a low and a high cell dose. In addition, a second low cell dose cohort will test the impact of additional vaccination boosts of SQZ-PBMC-HPV given in combination with atezolizumab. Participants may continue to receive atezolizumab study drug every 3 weeks for a maximum of 1 year or until discontinuation criteria are met.
 Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of autologous peripheral blood mononuclear cells (PBMCs) presenting immunogenic epitopes of the E6 and E7 proteins of HPV16

Drug: Atezolizumab
programmed cell death ligand 1 (PD-L1) blocking antibody


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 [ Time Frame: approximately 10 months ]
    For SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

  2. Maximum tolerated dose (MTD) [ Time Frame: approximately 6 weeks ]
    MTD of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

  3. Recommended Phase 2 dose (RP2D) [ Time Frame: approximately 10 months ]
    RP2D of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab


Secondary Outcome Measures :
  1. Number of patients with development of endogenous immune responses via ELISPOT in CD8 T cells [ Time Frame: Up to 1 year ]
    Immunogenic effects on peripheral blood cells of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

  2. Antitumor activity [ Time Frame: Up to 1 year ]
    Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy and in combination with atezolizumab

  3. Number of patients with change in blood cytokine levels [ Time Frame: Up to 1 year ]
    SQZ-PBMC-HPV as a single agent and in combination with atezolizumab


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥18 years of age who are HLA-A*02
  • Histologically confirmed incurable or metastatic solid tumors that are HPV16+
  • Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
  • At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

  • Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis
  • Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
  • History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
  • Significant acute or chronic illness
  • Major surgery within 2 weeks of leukapheresis
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084951


Contacts
Layout table for location contacts
Contact: Nicole D'Auteuil 978-758-9060 nicole.dauteuil@sqzbiotech.com

Locations
Layout table for location information
United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer    480-323-1364    clinicaltrials@honorhealth.com   
Principal Investigator: Michael S Gordon, MD         
United States, Colorado
University of Colorado Anschutz Cancer Pavillion Recruiting
Aurora, Colorado, United States, 80045
Contact: Ana Nguyen    720-848-4394    ana.nguyen@cuanschutz.edu   
Principal Investigator: Antonio Jimeno, MD, PhD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Information Program    800-811-8480    CIP@vumc.org   
Principal Investigator: Cathy Eng, MD         
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Abha Adat    713-745-4297    aadat@mdanderson.org   
Principal Investigator: Filip Janku, MD         
Sponsors and Collaborators
SQZ Biotechnologies
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: SQZ Biotechnologies
ClinicalTrials.gov Identifier: NCT04084951     History of Changes
Other Study ID Numbers: SQZ-PBMC-HPV-101
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SQZ Biotechnologies:
Solid tumors cancer
metastatic
locally advanced
cancer
cervical
head and neck
anal
 penile
SQZ-PBMC-HPV
atezolizumab
HPV16
APC
cell therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Atezolizumab
Antibodies, Monoclonal
 Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs