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History of Changes for Study: NCT04084951
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Latest version (submitted April 12, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 7, 2019 None (earliest Version on record)
2 November 7, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 November 8, 2019 Contacts/Locations and Study Status
4 November 18, 2019 Contacts/Locations and Study Status
5 December 5, 2019 Study Status and Contacts/Locations
6 December 8, 2019 Contacts/Locations and Study Status
7 January 2, 2020 Study Status and Contacts/Locations
8 January 30, 2020 Study Status
9 February 12, 2020 Contacts/Locations and Study Status
10 March 19, 2020 Contacts/Locations and Study Status
11 April 15, 2020 Contacts/Locations and Study Status
12 May 21, 2020 Contacts/Locations and Study Status
13 June 30, 2020 Outcome Measures, Eligibility, Arms and Interventions, Study Description and Study Status
14 October 6, 2020 Contacts/Locations and Study Status
15 October 7, 2020 Contacts/Locations and Study Status
16 December 1, 2020 Study Status and Contacts/Locations
17 February 3, 2021 Study Status and Contacts/Locations
18 April 28, 2021 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Study Design, Conditions, Study Description, Oversight and Study Identification
19 May 17, 2021 Study Status and Contacts/Locations
20 June 2, 2021 Study Status and Contacts/Locations
21 July 22, 2021 Study Status and Contacts/Locations
22 November 3, 2021 Study Status and Contacts/Locations
23 March 21, 2022 Contacts/Locations and Study Status
24 March 22, 2022 Contacts/Locations and Study Status
25 April 8, 2022 Study Status and Contacts/Locations
26 April 29, 2022 Outcome Measures, Contacts/Locations, Eligibility, Arms and Interventions, Conditions and Study Status
27 May 12, 2022 Study Status and Contacts/Locations
28 August 9, 2022 Study Status and Contacts/Locations
29 September 7, 2022 Contacts/Locations and Study Status
30 October 3, 2022 Contacts/Locations, Study Status and Eligibility
31 January 17, 2023 Recruitment Status, Study Status and Contacts/Locations
32 March 23, 2023 Study Status and Contacts/Locations
33 April 11, 2023 Study Status
34 April 12, 2023 Recruitment Status, Study Status and Study Design
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Study NCT04084951
Submitted Date:  September 7, 2019 (v1)
Open or close this module Study Identification
Unique Protocol ID: SQZ-PBMC-HPV-101
Brief Title: Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2019
Overall Status: Not yet recruiting
Study Start: November 2019
Primary Completion: November 2022 [Anticipated]
Study Completion: November 2022 [Anticipated]
First Submitted: September 1, 2019
First Submitted that
Met QC Criteria:		 September 7, 2019
First Posted: September 10, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:		 September 7, 2019
Last Update Posted: September 10, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: SQZ Biotechnologies
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Adult Solid Tumor
Keywords: Solid tumors cancer
metastatic
locally advanced
cancer
cervical
head and neck
anal
penile
SQZ-PBMC-HPV
atezolizumab
HPV16
APC
cell therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Semi-sequential enrollment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Nicole D'Auteuil
Telephone: 978-758-9060
Email: nicole.dauteuil@sqzbiotech.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services