Adult Solid TumorPhase 1NCT04084951
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing SQZ-PBMC-HPV, Atezolizumab and Ipilimumab in people with Adult Solid Tumor, run by SQZ Biotechnologies at 12 sites in 3 countries.
Trial 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… 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-PBMC-HPV, Atezolizumab and Ipilimumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 28 Jan 2020to 9 Feb 2023
- Phase
- Phase 1
- 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 who are HLA-A*02+ (performed during screening locally or centrally, or based on documented historic test results)
- Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- 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
Who cannot join
- 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 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
- Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
Show all 10Show fewer
- History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
- Has known active central nervous system metastases
- History of interstitial lung disease requiring steroids
- Major surgery within 2 weeks of leukapheresis
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
University of Colorado Anschutz Cancer Pavillion
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Masonic Cancer Center University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6840
Providence Cancer Institute
Portland, Oregon, 97213
HonorHealth
Scottsdale, Arizona, 85258
Germany1 site
University Hospital Cologne, Clinic I for Internal Medicine
Cologne, 50937
About this study
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
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.
- Conditions
- Adult Solid Tumor
- Being tested
- SQZ-PBMC-HPV, Atezolizumab, Ipilimumab, Nivolumab
- Keywords
- recurrent 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
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQZ-PBMC-HPVBiological
antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16
AtezolizumabDrug
programmed cell death ligand 1 (PD-L1) blocking antibody
IpilimumabDrug
cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
NivolumabDrug
programmed cell death 1 (PD-1) blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Monotherapy Dose Escalation Phase | Experimental | In Part 1, SQZ-PBMC-HPV as a monotherapy is administered on Day 1 of every 3 week cycles for up to a year. In Cohort 3 (double-priming), SQZ-PBMC-HPV is also administered on Day 2 of Cycle 1. There are at least 3 groups ("Cohorts") in this Phase as follows:
* Cohort 1: specified dose SQZ-PBMC-HPV
* Cohort 2: specified dose SQZ-PBMC-HPV
* Cohort 3: specified dose SQZ-PBMC-HPV double-priming Receives: Biological: SQZ-PBMC-HPV |
| Part 2 Combination Safety Phase | Experimental | 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:
* Cohort 4: SQZ-PBMC-HPV RP2D (Recommended Phase 2 Dose) plus atezolizumab
* Cohort 5: SQZ-PBMC-HPV RP2D plus ipilimumab
* Cohort 6: SQZ-PBMC-HPV RP2D plus nivolumab
* Cohort 7: SQZ-PBMC-HPV RP2D plus nivolumab and ipilimumab Receives: Biological: SQZ-PBMC-HPV; Drug: Atezolizumab; Drug: Ipilimumab; Drug: Nivolumab |
| Part 3 Monotherapy Dose Expansion Phase | Experimental | 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:
* Cohort 8: SQZ-PBMC-HPV RP2D in HPV16+ head and neck cancer patients
* Cohort 9: SQZ-PBMC-HPV RP2D in HPV16+ cervical cancer patients
* Cohort 10: SQZ-PBMC-HPV RP2D in HPV16+ anal cancer patients
* Cohort 11: SQZ-PBMC-HPV RP2D in other HPV16+ cancer patients Receives: Biological: SQZ-PBMC-HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)
Measured: Through 6 weeks after the patient's last dose of investigational product
Number of participants with dose-limiting toxicity (DLT)
For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)
Measured: Up to 1 year after LPFV
Objective response rate (ORR) [Part 3]
Proportion of patients with best response of complete response [CR] and/or partial response [PR] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
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) [Part 3]
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-PBMC-HPV as a single agent (Part 3 only)
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]
Progression-free survival (PFS) [Part 3]
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-PBMC-HPV as a single agent (Part 3 only)
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) [Part 3]
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-PBMC-HPV as a single agent (Part 3 only)
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) [Part 3]
Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
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) [Part 3]
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-PBMC-HPV as a single agent (Part 3 only)
Measured: Through study completion, up to 2 years
Secondary outcomes (7)
Objective response rate (ORR) [Part 1 and 2]
Proportion of patients with best response of complete response [CR] and/or partial response [PR] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
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) [Part 1 and 2]
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-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
Measured: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]
Progression-free survival (PFS) [Part 1 and 2]
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-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
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) [Part 1 and 2]
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-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
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) [Part 1 and 2]
Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
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) [Part 1 and 2]
For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
Measured: Through study completion, up to 2 years
Amount of investigational product (IP) from individual patient blood collection [Part 1]
To determine manufacturing feasibility (Part 1 only)
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 posted10 Sep 2019
- Study start28 Jan 2020
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04084951
- Sponsor's protocol ID
- SQZ-PBMC-HPV-101
- Status last verified
- Apr 2023
- First submitted
- 1 Sep 2019
- Last updated
- 14 Apr 2023
- 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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04084951
- Acronym / sponsor ID
- SQZ-PBMC-HPV-101
- Conditions
- Adult Solid Tumor
- Keywords
- recurrent cancer, metastatic, locally advanced, cancer, cervical, head and neck, anal, penile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SQZ BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 10 Sep 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Monotherapy Dose Escalation Phase | Experimental | Biological: SQZ-PBMC-HPVIn Part 1, SQZ-PBMC-HPV as a monotherapy is administered on Day 1 of every 3 week cycles for up to a year. In Cohort 3 (double-priming), SQZ-PBMC-HPV is also administered on Day 2 of Cycle 1. There are at least 3 groups ("Cohorts") in this Phase as follows: * Cohort 1: specified dose SQZ-PBMC-HPV * Cohort 2: specified dose SQZ-PBMC-HPV * Cohort 3: specified dose SQZ-PBMC-HPV double-priming |
| Part 2 Combination Safety Phase | Experimental | Biological: SQZ-PBMC-HPV, Drug: Atezolizumab, Drug: Ipilimumab, Drug: NivolumabIn 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: * Cohort 4: SQZ-PBMC-HPV RP2D (Recommended Phase 2 Dose) plus atezolizumab * Cohort 5: SQZ-PBMC-HPV RP2D plus ipilimumab * Cohort 6: SQZ-PBMC-HPV RP2D plus nivolumab * Cohort 7: SQZ-PBMC-HPV RP2D plus nivolumab and ipilimumab |
| Part 3 Monotherapy Dose Expansion Phase | Experimental | Biological: SQZ-PBMC-HPVIn 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: * Cohort 8: SQZ-PBMC-HPV RP2D in HPV16+ head and neck cancer patients * Cohort 9: SQZ-PBMC-HPV RP2D in HPV16+ cervical cancer patients * Cohort 10: SQZ-PBMC-HPV RP2D in HPV16+ anal cancer patients * Cohort 11: SQZ-PBMC-HPV RP2D in other HPV16+ cancer patients |
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 who are HLA-A*02+ (performed during screening locally or centrally, or based on documented historic test results)
- Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- 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
Key exclusion criteria (10 listed)
- 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 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-PBMC-HPVantigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16 | Biological | Part 1 Monotherapy Dose Escalation Phase, Part 2 Combination Safety Phase, Part 3 Monotherapy Dose Expansion Phase |
| Atezolizumabprogrammed cell death ligand 1 (PD-L1) blocking antibody | Drug | Part 2 Combination Safety Phase |
| Ipilimumabcytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody | Drug | Part 2 Combination Safety Phase |
| Nivolumabprogrammed cell death 1 (PD-1) blocking antibody | Drug | Part 2 Combination Safety Phase |
Primary outcome
Number of participants with treatment-related 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-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)
Number of participants with dose-limiting toxicity (DLT)
Time frame: Up to 1 year after LPFV
For SQZ-PBMC-HPV as a single agent (Part 1 and Part 3) and in combination with immune checkpoint inhibitors (Part 2)
Objective response rate (ORR) [Part 3]
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Proportion of patients with best response of complete response [CR] and/or partial response [PR] as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Best overall response (BoR) [Part 3]
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]
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-PBMC-HPV as a single agent (Part 3 only)
Progression-free survival (PFS) [Part 3]
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
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-PBMC-HPV as a single agent (Part 3 only)
Duration of Response (DoR) [Part 3]
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
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-PBMC-HPV as a single agent (Part 3 only)
Disease-control rate (DCR) [Part 3]
Time frame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-PBMC-HPV as a single agent (Part 3 only)
Overall survival (OS) [Part 3]
Time frame: Through study completion, up to 2 years
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-PBMC-HPV as a single agent (Part 3 only)
7 secondary outcomes
Objective response rate (ORR) [Part 1 and 2]
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) [Part 1 and 2]
Time frame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]
Progression-free survival (PFS) [Part 1 and 2]
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) [Part 1 and 2]
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) [Part 1 and 2]
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) [Part 1 and 2]
Time frame: Through study completion, up to 2 years
Amount of investigational product (IP) from individual patient blood collection [Part 1]
Time frame: From leukapheresis through manufacture, a maximum of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Related trials for Adult Solid Tumor
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SQZ-PBMC-HPV, Atezolizumab and Ipilimumab in people with Adult Solid Tumor, run by SQZ Biotechnologies at 12 sites in 3 countries.
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 10 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: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Germany. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-related 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 8 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 14 Apr 2023.