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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 : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
SQZ Biotechnologies

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

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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 : November 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

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
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Contact: Nicole D'Auteuil 978-758-9060 nicole.dauteuil@sqzbiotech.com

Sponsors and Collaborators
SQZ Biotechnologies

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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: September 10, 2019
Last Verified: September 2019

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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:
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Neoplasms
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs