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Checkpoint Inhibitor
SQZ-eAPC-HPV + Pembrolizumab for Solid Cancers
Phase 1 & 2
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
Histologically confirmed incurable or metastatic solid tumors that are HPV16+
Adequate organ function and bone marrow reserve performed within 14 days prior to leukapheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 6 weeks after the patient's last dose of investigational product
Awards & highlights
Study Summary
This trial is testing a new cancer treatment on humans for the first time to see if it is safe and works well. The treatment is for HPV16+ solid tumors anywhere in the body.
Who is the study for?
Adults with HPV16+ recurrent or metastatic solid tumors, such as head and neck, cervical, anal, vulvar, or penile cancer. Participants must have a measurable lesion for biopsy and not have used immune checkpoint inhibitors before. They should be in good health with proper organ function.Check my eligibility
What is being tested?
The trial is testing SQZ-eAPC-HPV alone and combined with Pembrolizumab to evaluate safety, effectiveness against tumors, and immune response in patients with HPV16+ solid tumors.See study design
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapies like inflammation of organs (immune-related adverse events), infusion reactions from the drugs being administered intravenously, fatigue, possible allergic responses to Pembrolizumab if previously known.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is incurable, has spread, and is HPV16 positive.
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My organs and bone marrow are working well, tested within the last 2 weeks.
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I am fully active or can carry out light work.
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I have never been treated with immune checkpoint inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 6 weeks after the patient's last dose of investigational product
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 6 weeks after the patient's last dose of investigational product
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 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 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 2 Lead-in Combination PhaseExperimental Treatment2 Interventions
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.
Group II: Part 1B Combination PhaseExperimental Treatment2 Interventions
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.
Group III: Part 1A Monotherapy Dose Escalation PhaseExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
SQZ BiotechnologiesLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with immune checkpoint inhibitors.My organs and bone marrow are working well, tested within the last 2 weeks.I have been treated with drugs that boost the immune system.My cancer is incurable, has spread, and is HPV16 positive.I have cancer that has spread to my brain.My side effects from previous cancer treatments have mostly resolved, except for some like nerve pain or hearing loss.I haven't had any cancer treatment in the last 2 weeks.I haven't taken non-corticosteroid immunosuppressants in the last 6 months.I am fully active or can carry out light work.I agree to have two biopsies for my condition with acceptable risk.I have not had major surgery within the last 2 weeks.I am 18 years old or older.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I do not have HIV, active hepatitis B or C, or active tuberculosis.I have lung disease and a history of heart inflammation.I have not been treated with immune checkpoint inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1B Combination Phase
- Group 2: Part 2 Lead-in Combination Phase
- Group 3: Part 1A Monotherapy Dose Escalation Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there capacity for additional participants in this experiment?
"According to information available on clinicaltrials.gov, the recruitment phase for this medical experiment is still ongoing; it was originally listed on March 24th 2022 and has most recently been updated on October 3rd 2022."
Answered by AI
What is the cap for participants in this clinical investigation?
"Affirmative, the clinical trial is currently open for enrollment as evidenced by its presence on clinicaltrials.gov. This medical research study was first posted online on March 24th 2022 and recently updated on October 3rd 2022 with a target of 60 participants from three different areas."
Answered by AI
What results are researchers expecting from this clinical experiment?
"The primary efficacy measure of this trial is the number of participants with dose-limiting toxicity (DLT). Secondary outcomes will focus on determining manufacturing feasibility, such as the amount and batch yield from individual patient blood collection. Additionally, a disease control rate (DCR) based on RECIST v1.1 criteria will be measured over 6 weeks after patients' last dose in Part 1A, Part 1B and Part 2 respectively for SQZ-eAPC monotherapy/HPV therapy combined with pembrolizumab or prior to treatment by pembrolizumab alone."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
Honor Health Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
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