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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRGN-2009 plus PembrolizumabExperimental Treatment1 Intervention

PRGN-2009 at a dose of 5 x 10^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w

Group II: Pembrolizumab aloneActive Control1 Intervention

Pembrolizumab, 400mg q6w

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,395 Total Patients Enrolled

3 Trials studying HPV-Related Malignancy

33,506 Patients Enrolled for HPV-Related Malignancy

Precigen, IncLead Sponsor

5 Previous Clinical Trials

297 Total Patients Enrolled

Frequently Asked Questions

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

Is this medical experiment currently seeking new participants?

"Clinicaltrials.gov data affirms that the recruitment period for this particular clinical trial has ended; it was initially posted on December 3rd 2023 and last updated on November 27th 2023. Fortunately, 415 other studies are currently recruiting participants right now."

Answered by AI

What evidence exists to suggest that PRGN-2009 combined with Pembrolizumab is secure for patients?

"After careful consideration, our team at Power has concluded that PRGN-2009 plus Pembrolizumab is likely safe enough for clinical use and gave it a rating of 2. As this is a Phase 2 trial, limited safety information and no efficacy data exist."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer

2024. "PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06157151.

All > Cervical Cancer