A Phase 1 interventional study of SQZ-PBMC-HPV and Atezolizumab in Adult Solid Tumor, sponsored by SQZ Biotechnologies. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by SQZ Biotechnologies · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →SQZ Biotechnologies is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Exclusion Criteria:
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
Biological: SQZ-PBMC-HPV
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
Biological: SQZ-PBMC-HPV · Drug: Atezolizumab · Drug: Ipilimumab · Drug: Nivolumab
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
Biological: SQZ-PBMC-HPV
antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16
programmed cell death ligand 1 (PD-L1) blocking antibody
cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
programmed cell death 1 (PD-1) blocking antibody
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)
Time frame: 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)
Time frame: 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)
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 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)
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 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)
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 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)
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 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)
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 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)
Time frame: Through study completion, up to 2 years
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)
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]
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)
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]
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)
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]
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)
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]
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)
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]
For SQZ-PBMC-HPV as a single agent (Part 1) and in combination with immune checkpoint inhibitors (Part 2)
Time frame: 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)
Time frame: From leukapheresis through manufacture, a maximum of 28 days
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SQZ Biotechnologies