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

Cervical Cancer Clinical Trial

Official title:

A Randomized, Open-label, Two-arm, Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157151
• Other study ID #: PRGN-2009-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: January 30, 2028

Study information

• Verified date: April 2024
• Source: Precigen, Inc
• Contact: Amy Lankford
• Phone: 3015569900
• Email: clinicaltrials[@]precigen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

Description:

This is a randomized, two-arm study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will be randomized 1:1 to receive a combination of PRGN-2009, plus pembrolizumab, or to receive pembrolizumab alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 30, 2028
• Est. primary completion date: January 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older.
• Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
• Must have been treated with pembrolizumab, either as monotherapy or in combination
• Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
• Tumors are confirmed positive for PD-L1 and HPV16/18
• Measurable disease that can be accurately measured by RECIST v1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy = 12 weeks from the time of enrollment.
• Must have adequate organ function
• Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.
• All patients must have the ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

• Patients with presence of other active malignancy within 1 year prior to study entry
• Known Central Nervous System (CNS) disease
• Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
• Known history of active tuberculosis (TB, Bacillus tuberculosis).
• Pregnant and lactating women are excluded from this study.
• Patients with a history of solid organ transplant.
• Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
• Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.

Related Conditions & MeSH terms

• Cervical Cancer
• HPV-Related Carcinoma
• HPV-Related Malignancy
• Uterine Cervical Neoplasms

Intervention

Biological:
• PRGN-2009 plus Pembrolizumab
Subjects randomized will receive PRGN-2009 (5 x 10^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks.

Drug:
• Pembrolizumab alone
Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.

Locations

Country	Name	City	State
United States	National Institute of Health	Bethesda	Maryland
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Precigen, Inc	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1.; ORR will be calculated and presented with 2-sided 95% confidence interval.	1 year
Secondary	Safety of PRGN-2009 in combination with pembrolizumab or pembrolizumab alone	Systemic toxicity will be assessed through the capture of Treatment Emergent Adverse Events ( TEAEs). The severity of the TEAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 scale.	1 year
Secondary	Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone	Duration of PFS and OS will be summarized using the Kaplan-Meier Product Limit estimator along with the corresponding two sided-95% Confidence intervals.	1 year
Secondary	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	The proportion of subjects with BOR and DCR will be summarized using descriptive statistics.	1 year
Secondary	Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone	TTR and DOR will be summarized using descriptive statistics.	1 year
Secondary	Vector shedding following subcutaneous administration of PRGN-2009	Samples collected before and at specific intervals after treatment will be evaluated for presence of adenoviral vector.	Up to 4 months