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

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ClinicalTrials.gov Identifier: NCT04084951
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
SQZ Biotechnologies

Tracking Information
First Submitted Date  ICMJE September 1, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE January 28, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2019)
  • 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
  • Maximum tolerated dose (MTD) [ Time Frame: approximately 6 weeks ]
    MTD of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
  • Recommended Phase 2 dose (RP2D) [ Time Frame: approximately 10 months ]
    RP2D of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Antitumor activity [ Time Frame: Up to 1 year ]
    Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy and in combination with atezolizumab
  • Manufacturing feasibility [ Time Frame: 1 year ]
    number of vials
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2019)
  • 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
  • Antitumor activity [ Time Frame: Up to 1 year ]
    Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy and in combination with atezolizumab
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: June 30, 2020)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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
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. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Semi-sequential enrollment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adult Solid Tumor
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Dose escalation of SQZ-PBMC-HPV
    In the monotherapy escalation cohorts, SQZ-PBMC-HPV is administered every 3 weeks for up to a year as a low and a high cell dose. In addition, a second high dose cell cohort will test the impact of a double-prime regimen where SQZ-PBMC-HPV is administered on two consecutive days followed by doses every 3 weeks for a maximum of a year.
    Intervention: Biological: SQZ-PBMC-HPV
  • 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 a year at intervals of 3 weeks as a low and a high cell dose. In addition, a second high dose cell dose cohort will test the impact of a double-prime regimen 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.
    Interventions:
    • Biological: SQZ-PBMC-HPV
    • Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Patients must agree to venous access for the leukapheresis and be willing to have a central line inserted if venous access is an issue.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Benjamin Greenberg 978 407 6007 PBMC-HPV-101@sqzbiotech.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04084951
Other Study ID Numbers  ICMJE SQZ-PBMC-HPV-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SQZ Biotechnologies
Study Sponsor  ICMJE SQZ Biotechnologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SQZ Biotechnologies
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP