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

Precigen

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Cervical Cancer; HPV-Related Carcinoma; Recurrent Cervical Carcinoma; HPV-Related Malignancy; Cervical Cancer

Treatments: Biological: PRGN-2009 plus Pembrolizumab; Drug: Pembrolizumab alone

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06157151

PRGN-2009-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

PRGN-2009 plus Pembrolizumab

Experimental group

Description:

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

Treatment:

Biological: PRGN-2009 plus Pembrolizumab

Pembrolizumab alone

Active Comparator group

Description:

Pembrolizumab, 400mg q6w

Treatment:

Drug: Pembrolizumab alone