Adult Solid TumorPhase 1/2NCT05357898
Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing SQZ-eAPC-HPV and Pembrolizumab in people with Adult Solid Tumor, run by SQZ Biotechnologies at 9 sites in United States.
Trial summary
This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Solid Tumor
- What is being tested?
- SQZ-eAPC-HPV and Pembrolizumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 9 sitesUnited States
- Study dates
- 24 Mar 2022to 27 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years of age
- Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- 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 Screening and on Cycle 2 Day 8 (+/- 2 days)
- Patients must agree to venous access for 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 leukapheresis
- Patients must not have been treated with immune check-point inhibitors
Who cannot join
- Treatment with anticancer therapy, including investigational therapy, within 2 weeks 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 prior to leukapheresis
- 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 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
- Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
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- Has known active central nervous system metastases
- Have active interstitial lung disease and any history of myocarditis
- Major surgery within 2 weeks of leukapheresis
- Known hypersensitivity to pembrolizumab
- History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
- Prior treatment with an immune check-point inhibitor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Colorado Anschutz Cancer Pavillion
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
City of Hope Medical Center
Duarte, California, 91010
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6840
Honor Health Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors
This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.
- Conditions
- Adult Solid Tumor
- Being tested
- SQZ-eAPC-HPV, Pembrolizumab
- Keywords
- recurrent cancer, metastatic, locally advanced, cancer, head and neck cancer, cervical, anal, vulvar, penile, SQZ-eAPC-HPV, HPV16, human papillomavirus 16, eAPC, enhanced antigen presenting cells, cell therapy, pembrolizumab, checkpoint inhibitors, immunotherapy, solid tumor, therapeutic vaccine
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQZ-eAPC-HPVBiological
Enhanced antigen presenting cells (eAPC) cell therapy; therapeutic vaccine engineered from autologous peripheral blood mononuclear cells (PBMCs) by incorporating 5 mRNAs.
PembrolizumabBiological
programmed cell death 1 (PD-1) blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Monotherapy Dose Escalation Phase | Experimental | In Part 1A, SQZ-eAPC-HPV as a monotherapy is administered every 3 weeks for up to a year.
There are 3 groups ("Cohorts") in this Phase as follows:
* Cohort 1: low dose SQZ-eAPC-HPV
* Cohort 2: intermediate dose SQZ-eAPC-HPV
* Cohort 3: high dose SQZ-eAPC-HPV
Additional provisional cohorts may be opened prior to starting Part 1B. Receives: Biological: SQZ-eAPC-HPV |
| Part 1B Combination Phase | Experimental | In Part 1B, SQZ-eAPC-HPV is administered in combination with immune checkpoint inhibitor pembrolizumab. SQZ-eAPC-HPV will be administered on Day 1 of Cycle 1 and 200 mg of pembrolizumab will be administered on Day 8 of Cycle 1. In future cycles, patients will be first administered SQZ-eAPC-HPV and then pembrolizumab on the first day of each cycle, every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab. Receives: Biological: SQZ-eAPC-HPV; Biological: Pembrolizumab |
| Part 2 Lead-in Combination Phase | Experimental | In Part 2, SQZ-eAPC-HPV will be administered on Day 1 of each treatment cycle. Treatment with 200 mg of pembrolizumab will begin in Cycle 3. Starting at Cycle 3, patients will be administered SQZ-eAPC-HPV and then pembrolizumab every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab. Receives: Biological: SQZ-eAPC-HPV; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through 6 weeks after the patient's last dose of investigational product
Number of participants with dose-limiting toxicity (DLT)
For SQZ-eAPC-HPV as a monotherapy (Part 1A).
Measured: Through Day 28
Number of participants with dose-limiting toxicity (DLT)
For SQZ-eAPC-HPV in combination with pembrolizumab (Part 1B).
Measured: Through Day 42
Secondary outcomes (8)
Objective response rate (ORR)
Proportion of patients with best response of complete response [CR] and/or partial response [PR] as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Best overall response (BoR)
Evaluation of the BoR defined as CR, PR, Stable Disease [SD], Progressive Disease [PD] or Not Evaluable [NE] as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Progression-free survival (PFS)
Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Duration of Response (DoR)
Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Disease-control rate (DCR)
Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Overall survival (OS)
Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Measured: Through study completion, up to 2 years
Amount of investigational product (IP) from individual patient blood collection - batch yield
To determine manufacturing feasibility as assessed by batch yield (number of manufacturing runs)
Measured: From leukapheresis through manufacture, a maximum of 28 days
Amount of investigational product (IP) from individual patient blood collection - product failures
To determine manufacturing feasibility as assessed by number of product failures
Measured: From leukapheresis through manufacture, a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start24 Mar 2022
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Why it stopped: Corporate Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SQZ Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357898
- Sponsor's protocol ID
- COMMANDER-001
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05357898
- Acronym / sponsor ID
- COMMANDER-001
- Conditions
- Adult Solid Tumor
- Keywords
- recurrent cancer, metastatic, locally advanced, cancer, head and neck cancer, cervical, anal, vulvar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate Decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SQZ BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1A Monotherapy Dose Escalation Phase | Experimental | Biological: SQZ-eAPC-HPVIn Part 1A, SQZ-eAPC-HPV as a monotherapy is administered every 3 weeks for up to a year. There are 3 groups ("Cohorts") in this Phase as follows: * Cohort 1: low dose SQZ-eAPC-HPV * Cohort 2: intermediate dose SQZ-eAPC-HPV * Cohort 3: high dose SQZ-eAPC-HPV Additional provisional cohorts may be opened prior to starting Part 1B. |
| Part 1B Combination Phase | Experimental | Biological: SQZ-eAPC-HPV, Biological: PembrolizumabIn Part 1B, SQZ-eAPC-HPV is administered in combination with immune checkpoint inhibitor pembrolizumab. SQZ-eAPC-HPV will be administered on Day 1 of Cycle 1 and 200 mg of pembrolizumab will be administered on Day 8 of Cycle 1. In future cycles, patients will be first administered SQZ-eAPC-HPV and then pembrolizumab on the first day of each cycle, every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab. |
| Part 2 Lead-in Combination Phase | Experimental | Biological: SQZ-eAPC-HPV, Biological: PembrolizumabIn Part 2, SQZ-eAPC-HPV will be administered on Day 1 of each treatment cycle. Treatment with 200 mg of pembrolizumab will begin in Cycle 3. Starting at Cycle 3, patients will be administered SQZ-eAPC-HPV and then pembrolizumab every 3 weeks for a maximum of 1 year for SQZ-eAPC-HPV, and 2 years for pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients ≥18 years of age
- Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- 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 Screening and on Cycle 2 Day 8 (+/- 2 days)
Key exclusion criteria (12 listed)
- Treatment with anticancer therapy, including investigational therapy, within 2 weeks 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 prior to leukapheresis
- 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 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQZ-eAPC-HPVEnhanced antigen presenting cells (eAPC) cell therapy; therapeutic vaccine engineered from autologous peripheral blood mononuclear cells (PBMCs) by incorporating 5 mRNAs. | Biological | Part 1A Monotherapy Dose Escalation Phase, Part 1B Combination Phase, Part 2 Lead-in Combination Phase |
| Pembrolizumabprogrammed cell death 1 (PD-1) blocking antibody | Biological | Part 1B Combination Phase, Part 2 Lead-in Combination Phase |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
Time frame: Through 6 weeks after the patient's last dose of investigational product
For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Number of participants with dose-limiting toxicity (DLT)
Time frame: Through Day 28
For SQZ-eAPC-HPV as a monotherapy (Part 1A).
Number of participants with dose-limiting toxicity (DLT)
Time frame: Through Day 42
For SQZ-eAPC-HPV in combination with pembrolizumab (Part 1B).
8 secondary outcomes
Objective response rate (ORR)
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Best overall response (BoR)
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
Progression-free survival (PFS)
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Duration of Response (DoR)
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Disease-control rate (DCR)
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Overall survival (OS)
Time frame: Through study completion, up to 2 years
Amount of investigational product (IP) from individual patient blood collection - batch yield
Time frame: From leukapheresis through manufacture, a maximum of 28 days
Amount of investigational product (IP) from individual patient blood collection - product failures
Time frame: From leukapheresis through manufacture, a maximum of 28 days
Results and safety
The study was stopped early (reason given: Corporate Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SQZ-eAPC-HPV and Pembrolizumab in people with Adult Solid Tumor, run by SQZ Biotechnologies at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Corporate Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0 (time frame: Through 6 weeks after the patient's last dose of investigational product). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.