Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
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| ClinicalTrials.gov Identifier: NCT04084951 |
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Recruitment Status :
Recruiting
First Posted : September 10, 2019
Last Update Posted : December 3, 2020
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Sponsor:
SQZ Biotechnologies
Information provided by (Responsible Party):
SQZ Biotechnologies
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult Solid Tumor | Biological: SQZ-PBMC-HPV Drug: Atezolizumab | Phase 1 |
| 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 |
| Actual Study Start Date : | January 28, 2020 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2022 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 :
- 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
Secondary Outcome Measures :
- 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
Other Outcome Measures:
- 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
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
- 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
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
| Contact: Ricardo F. Zwirtes, MD | 203-506-7253 | PBMC-HPV-101@sqzbiotech.com |
Locations
| 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, California | |
| Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Kari Kayser, BSN, RN,CCRP 310-967-0694 kari.kayser@cshs.org | |
| Principal Investigator: Monica Mita, 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, Kansas | |
| University of Kansas Cancer Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Jeff Roesgen 913-945-8679 jroesgen@kumc.edu | |
| Principal Investigator: Joaquina Baranda, MD | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: DFCI Clinical Trials Hotline 877-338-7425 | |
| Principal Investigator: Ursula Matulonis, MD | |
| United States, Oregon | |
| Providence Cancer Institute | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Research Office 503-215-2614 canrsrchstudies@providence.org | |
| Principal Investigator: Matthew H Taylor, MD | |
| 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 | 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
| Responsible Party: | SQZ Biotechnologies |
| ClinicalTrials.gov Identifier: | NCT04084951 |
| Other Study ID Numbers: |
SQZ-PBMC-HPV-101 |
| First Posted: | September 10, 2019 Key Record Dates |
| Last Update Posted: | December 3, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by SQZ Biotechnologies:
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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 Antineoplastic Agents |