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Checkpoint Inhibitor

SQZ-AAC-HPV for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by SQZ Biotechnologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after lpfv (last patient, first visit)
Awards & highlights

Study Summary

This trial is testing a new cancer treatment in people with HPV16+ solid tumors. The treatment will be given alone and with other cancer treatments to see how well it works and if it has any side effects.

Who is the study for?
This trial is for adults with HPV16+ solid tumors that have returned or spread, and who are HLA-A*02+. They should be relatively healthy (ECOG 0-1), have at least one measurable tumor lesion, and acceptable organ function. Participants must have tried standard treatments without success or cannot tolerate them. Those with autoimmune diseases, recent immunosuppressive treatments, unresolved severe side effects from past cancer therapies, or active infections like hepatitis B/C are excluded.Check my eligibility
What is being tested?
The study tests SQZ-AAC-HPV alone and combined with immune checkpoint inhibitors Ipilimumab and Nivolumab in patients with various cancers including anal, cervical, head/neck cancers. It's a Phase 1 trial to assess safety, immune response enhancement capabilities of the treatment(s), their effectiveness against the tumors, and how they affect the body.See study design
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapies such as fatigue, skin reactions (rash), digestive issues (diarrhea), hormonal imbalances (thyroid disorders) due to Ipilimumab/Nivolumab; specific side effects related to SQZ-AAC-HPV will also be monitored given its investigational nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 or older and have HLA-A*02 positive status.
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My cancer is incurable or has spread, and tests show it's HPV16+.
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I agree to have two biopsies for my condition with acceptable risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after lpfv
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after lpfv for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with DLT
Number of participants with dose-limiting toxicity (DLT)
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
Secondary outcome measures
Amount of investigational product (IP) from individual patient blood collection - batch yield
Amount of investigational product (IP) from individual patient blood collection - product failures
Best overall Response (BoR)
+5 more
Other outcome measures
Changes in T cell infiltration in the tumor micro-environment as assessed by paired biopsy
Changes in cytokine levels compared with baseline

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 Combination Safety PhaseExperimental Treatment3 Interventions
In Part 2, SQZ-AAC-HPV in combination with immune checkpoint inhibitors (1) ipilimumab, (2) nivolumab, or (3) nivolumab plus ipilimumab is administered every 3 weeks up to a year, but the immune checkpoint inhibitors may be administered up to 2 years. There are 3 groups ("Cohorts") in this Phase as follows: Cohort 2a: SQZ-AAC-HPV RP2D (Recommended Phase 2 Dose) plus ipilimumab Cohort 2b: SQZ-AAC-HPV RP2D plus nivolumab Cohort 2c: SQZ-AAC-HPV RP2D plus nivolumab and ipilimumab
Group II: Part 1 Monotherapy Dose Escalation PhaseExperimental Treatment1 Intervention
In Part 1, SQZ-AAC-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 1a: low dose SQZ-AAC-HPV Cohort 1b: high dose SQZ-AAC-HPV Cohort 1c: higher or lower dose SQZ-AAC-HPV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

SQZ BiotechnologiesLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04892043 — Phase 1
Solid Tumors Research Study Groups: Part 1 Monotherapy Dose Escalation Phase, Part 2 Combination Safety Phase
Solid Tumors Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04892043 — Phase 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04892043 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of recruitment for this experiment?

"To conduct this trial, SQZ Biotechnologies requires 72 candidates that meet the predefined criteria. This research will be conducted at various locations including Oregon Health & Science University in Portland and Barbara Ann Karmanos Cancer Institute in Detroit."

Answered by AI

Are there any potential adverse effects of SQZ-AAC-HPV usage?

"As this is an early-stage trial, the safety of SQZ-AAC-HPV was estimated to be a 1 due to limited data regarding its efficacy and potential risks."

Answered by AI

How many healthcare centers are participating in the clinical trial?

"Currently, this medical trial is being carried out at 6 separate facilities. Principally in Portland, Detroit and La Jolla but other locations are also participating. To reduce the amount of travelling required for participation it may be wise to select a facility as close to you as possible."

Answered by AI

Are there any historical studies that have been conducted regarding SQZ-AAC-HPV?

"SQZ-AAC-HPV was first trialled at Texas Children's Hospital in 2009 and there have been 365 concluded trials to date. At present, 764 clinical investigations are ongoing with many taking place in Portland, Oregon."

Answered by AI

What is the application of SQZ-AAC-HPV in healthcare?

"Anti-angiogenic therapy is often addressed with the use of SQZ-AAC-HPV. This medication has also been shown to be effective for treating malignant neoplasms, inoperable melanomas, and squamous cell carcinoma."

Answered by AI

What is the ultimate objective of this research experiment?

"This trial, tracked over the course of one year post-initiating Last Patient First Visit (LPFV), studies dose-limiting toxicity (DLT). Secondary objectives include Overall Survival (OS) and manufacturing feasibility as assessed by batch yield. Additionally, SQZ-AAC-HPV's antitumor activity is evaluated with RECIST 1.1 and iRECIST in both monotherapy and combination therapy settings."

Answered by AI

Are those seeking treatment currently being accepted into this research endeavor?

"Affirmative. According to the information available on clinicaltrials.gov, this medical trial is still recruiting participants after its original posting date of August 19th 2021 and most recent edit on November 15th 2022. The researchers are aiming to enrol 72 patients between 6 sites in total."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
2021. "Study of SQZ-AAC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04892043.
~1 spots leftby Apr 2025
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