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 : July 23, 2021
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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 or other immune checkpoint inhibitors 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 Drug: Ipilimumab Drug: Nivolumab | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| 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 or Other Immune Checkpoint Inhibitors 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: Part 1 Monotherapy Dose Escalation Phase
In Part 1, SQZ-PBMC-HPV as a monotherapy is administered every 3 weeks for up to a year. There are at least 3 groups ("Cohorts") in this Phase as follows:
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Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16 |
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Experimental: Part 2 Combination Safety Phase
In Part 2, SQZ-PBMC-HPV in combination with immune checkpoint inhibitors (1) atezolizumab, (2) ipilimumab, (3) nivolumab, or (4) nivolumab and ipilimumab, is administered every 3 weeks for up to a year except atezolizumab may be given up to 2 years; and ipilimumab will be administered four times (in a timeframe less than a year) if safety allows. There are 4 groups ("Cohorts") in this Phase as follows:
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Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16 Drug: Atezolizumab programmed cell death ligand 1 (PD-L1) blocking antibody Drug: Ipilimumab cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody Drug: Nivolumab programmed cell death 1 (PD-1) blocking antibody |
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Experimental: Part 3 Monotherapy Dose Expansion Phase
In Part 3, SQZ-PBMC-HPV is administered at the RP2D to patients enrolled in HPV16+ cancer-type specific cohorts. There are 4 groups ("Cohorts") in this Phase as follows:
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Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16 |
Primary Outcome Measures :
- Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 [ Time Frame: Up to 1 year after LPFV (Last Patient, First Visit) ]For SQZ-PBMC-HPV as a single agent and in combination with immune checkpoint inhibitors
- Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 1 year after LPFV ]RP2D of SQZ-PBMC-HPV as a single agent and in combination with immune checkpoint inhibitors
- Antitumor activity (Part 3 only) [ Time Frame: Up to 1 year after LPFV ]Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy
Secondary Outcome Measures :
- Antitumor activity (Parts 1 and 2) [ Time Frame: Up to 1 year after LPFV ]Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy and in combination with immune checkpoint inhibitors
- Manufacturing feasibility (Part 1 only) [ Time Frame: Up to 3 months after LPFV ]Individual patient batch yields
Other Outcome Measures:
- Number of patients with change in blood cytokine levels [ Time Frame: Up to 1 year after LPFV ]SQZ-PBMC-HPV as a single agent and in combination with immune checkpoint inhibitors
- Number of patients with development of endogenous immune responses as assessed by functional assay in CD8 T cells [ Time Frame: Up to 1 year after LPFV ]Immunogenic effects on peripheral blood cells of SQZ-PBMC-HPV as a single agent and in combination with immune checkpoint inhibitors
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
Key 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
- Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Baseline and on Cycle 2 Day 8 (+/- 3 days)
- Patients must agree to venous access for the 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 the leukapheresis
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
- 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 may not be eligible and should be discussed with the Sponsor
- 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 alopecia
- Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
- History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
- Has known active central nervous system metastases
- History of interstitial lung disease requiring steroids
- 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 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Betsy Valles, RN bvalles@partners.org | |
| Principal Investigator: Jong Chul Park, MD | |
| 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, 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, 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: Wade Thomas Iams, MD | |
| Canada, Ontario | |
| Princess Margaret Cancer Centre | Recruiting |
| Toronto, Ontario, Canada, M5G 2C1 | |
| Contact: New Patient Referral Centre (NPRC) 416-946-4575 | |
| Principal Investigator: Neesha Dhani, 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: | July 23, 2021 |
| Last Verified: | July 2021 |
| 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 ipilimumab nivolumab checkpoint inhibitors immunotherapy solid tumor HLA-A*02 therapeutic vaccine |
Additional relevant MeSH terms:
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Neoplasms Nivolumab Ipilimumab |
Atezolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |