We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of SQZ-eAPC-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: NCT05357898
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : May 26, 2023
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 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.

Condition or disease Intervention/treatment Phase
Adult Solid Tumor Biological: SQZ-eAPC-HPV Biological: Pembrolizumab Phase 1 Phase 2

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 : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors
Actual Study Start Date : March 24, 2022
Estimated Primary Completion Date : March 24, 2024
Estimated Study Completion Date : March 24, 2024

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: Part 1A Monotherapy Dose Escalation Phase

In Part 1A, SQZ-eAPC-HPV as a monotherapy is administered every 3 weeks for up to a year.

There are 3 groups ("Cohorts") in this Phase as follows:

  • Cohort 1: low dose SQZ-eAPC-HPV
  • Cohort 2: intermediate dose SQZ-eAPC-HPV
  • Cohort 3: high dose SQZ-eAPC-HPV

Additional provisional cohorts may be opened prior to starting Part 1B.

 Biological: SQZ-eAPC-HPV
Enhanced antigen presenting cells (eAPC) cell therapy; therapeutic vaccine engineered from autologous peripheral blood mononuclear cells (PBMCs) by incorporating 5 mRNAs.
Experimental: Part 1B Combination Phase
In Part 1B, SQZ-eAPC-HPV is administered in combination with immune checkpoint inhibitor pembrolizumab. SQZ-eAPC-HPV will be administered on Day 1 of Cycle 1 and 200 mg of pembrolizumab will be administered on Day 8 of Cycle 1. In future cycles, patients will be first administered SQZ-eAPC-HPV and then pembrolizumab on the first day of each cycle, every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab.
 Biological: SQZ-eAPC-HPV
Enhanced antigen presenting cells (eAPC) cell therapy; therapeutic vaccine engineered from autologous peripheral blood mononuclear cells (PBMCs) by incorporating 5 mRNAs.

Biological: Pembrolizumab
programmed cell death 1 (PD-1) blocking antibody
Experimental: Part 2 Lead-in Combination Phase
In Part 2, SQZ-eAPC-HPV will be administered on Day 1 of each treatment cycle. Treatment with 200 mg of pembrolizumab will begin in Cycle 3. Starting at Cycle 3, patients will be administered SQZ-eAPC-HPV and then pembrolizumab every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab.
 Biological: SQZ-eAPC-HPV
Enhanced antigen presenting cells (eAPC) cell therapy; therapeutic vaccine engineered from autologous peripheral blood mononuclear cells (PBMCs) by incorporating 5 mRNAs.

Biological: Pembrolizumab
programmed cell death 1 (PD-1) 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-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0 [ Time Frame: Through 6 weeks after the patient's last dose of investigational product ]
    For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  2. Number of participants with dose-limiting toxicity (DLT) [ Time Frame: Through Day 28 ]
    For SQZ-eAPC-HPV as a monotherapy (Part 1A).

  3. Number of participants with dose-limiting toxicity (DLT) [ Time Frame: Through Day 42 ]
    For SQZ-eAPC-HPV in combination with pembrolizumab (Part 1B).


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product ]
    Proportion of patients with best response of complete response [CR] and/or partial response [PR] as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  2. Best overall response (BoR) [ Time Frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product ]
    Evaluation of the BoR defined as CR, PR, Stable Disease [SD], Progressive Disease [PD] or Not Evaluable [NE] as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  3. Progression-free survival (PFS) [ Time Frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product ]
    Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  4. Duration of Response (DoR) [ Time Frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product ]
    Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  5. Disease-control rate (DCR) [ Time Frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product ]
    Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  6. Overall survival (OS) [ Time Frame: Through study completion, up to 2 years ]
    Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).

  7. Amount of investigational product (IP) from individual patient blood collection - batch yield [ Time Frame: From leukapheresis through manufacture, a maximum of 28 days ]
    To determine manufacturing feasibility as assessed by batch yield (number of manufacturing runs)

  8. Amount of investigational product (IP) from individual patient blood collection - product failures [ Time Frame: From leukapheresis through manufacture, a maximum of 28 days ]
    To determine manufacturing feasibility as assessed by number of product failures


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 - All Patients:

  • Male or female patients ≥18 years of age
  • Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
  • At least 1 measurable lesion according to RECIST 1.1
  • Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and on Cycle 2 Day 8 (+/- 2 days)
  • Patients must agree to venous access for leukapheresis and be willing to have a central line inserted if venous access is an issue
  • Adequate organ function and bone marrow reserve performed within 14 days prior to leukapheresis

Inclusion Criteria - Part 2:

• Patients must not have been treated with immune check-point inhibitors

Exclusion Criteria - All Patients:

  • Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis.
  • Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
  • Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months prior to leukapheresis
  • Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
  • Patients with >Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except Grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
  • Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
  • Has known active central nervous system metastases
  • Have active interstitial lung disease and any history of myocarditis
  • Major surgery within 2 weeks of leukapheresis

Exclusion Criteria - Part 1B:

  • Known hypersensitivity to pembrolizumab
  • History of any Grade 3 immune-related AE (irAE) from prior immunotherapy

Exclusion Criteria - Part 2:

• Prior treatment with an immune check-point inhibitor

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): NCT05357898


Contacts
Layout table for location contacts
Contact: Marshelle Smith Warren, MD 857-760-0919 patientadvocacy@sqzbiotech.com

Locations
Layout table for location information
United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Clinical Trials       clinicaltrials@honorhealth.com   
Principal Investigator: Michael Gordon, MD         
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Victoria M Villaflor, MD    877-467-3411    vvillaflor@coh.org   
Principal Investigator: Victoria M Villaflor, 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, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Jong Chul Park, MD         
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Cancer Information Nurse Line       ccinfo@umn.edu   
Principal Investigator: Naomi Fujioka, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6840
Contact: Pamela Nielsen       pnielsen@nebraskamed.com   
Principal Investigator: Kerry Rodabaugh, MD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Principal Investigator: Trisha Wise-Draper, MD         
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon       asksarah@sarahcannon.com   
Principal Investigator: Meredith Sellers Pelster, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Information Program    800-811-8480    CTIP@VUMC.ORG   
Principal Investigator: Wade Thomas Iams, 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: NCT05357898    
Other Study ID Numbers: COMMANDER-001
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023

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:
recurrent cancer
metastatic
locally advanced
cancer
head and neck cancer
cervical
anal
vulvar
penile
SQZ-eAPC-HPV
HPV16
 human papillomavirus 16
eAPC
enhanced antigen presenting cells
cell therapy
pembrolizumab
checkpoint inhibitors
immunotherapy
solid tumor
therapeutic vaccine
advanced solid tumor
throat cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action