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Checkpoint Inhibitor

PRGN-2009 + Pembrolizumab for Cervical Cancer

Phase 2

Recruiting

Research Sponsored by Precigen, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant

Must not have

Patients with presence of other active malignancy within 1 year prior to study entry

Known Central Nervous System (CNS) disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will see if adding PRGN-2009 to pembrolizumab helps treat cervical cancer that doesn't respond to pembrolizumab alone.

Who is the study for?

This trial is for adults over 18 with recurrent or metastatic cervical cancer resistant to pembrolizumab. Participants must have tried no more than two systemic treatments, have PD-L1 and HPV16/18 positive tumors, measurable disease, good performance status (ECOG 0 or 1), and a life expectancy of at least 12 weeks. Women must not be pregnant, agree to contraception use during the study and for six months after.

What is being tested?

The trial compares PRGN-2009 combined with Pembrolizumab versus Pembrolizumab alone in patients whose cervical cancer has returned or spread despite previous treatment with Pembrolizumab. It aims to assess the effectiveness and safety of this new combination therapy.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions similar to allergic responses, fatigue, issues affecting digestion and blood cells, along with an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cervical cancer has returned or spread and does not respond to pembrolizumab.

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I have been treated with pembrolizumab, alone or with other drugs.

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I have had 2 or fewer treatments for my cancer after it returned or spread.

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My tumor is positive for PD-L1 and HPV16/18.

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My cancer can be measured using standard imaging tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other active cancer in the past year.

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I have a diagnosed brain or spinal cord condition.

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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

Secondary study objectives

Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone

Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone

Safety of PRGN-2009 in combination with pembrolizumab or pembrolizumab alone

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