Clinical trial NCT06157151: PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer
Official title: A Randomized, Open-label, Two-arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
HPV-Related Carcinoma
HPV-Related Malignancy
Recurrent Cervical Carcinoma
Metastatic Cervical Cancer
Keywords: Human Papilloma Virus
Cervical Cancer
Pembrolizumab
Therapeutic Vaccine
Cervix Cancer
Resistance to Checkpoint Inhibitors
Lead sponsor: Precigen, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-12-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label, randomized study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Safety of PRGN-2009 in combination with pembrolizumab or pembrolizumab alone
timeFrame: 1 year
measure: Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone
timeFrame: 1 year
measure: Vector shedding following subcutaneous administration of PRGN-2009
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bethesda
country: United States
facility: National Institute of Health
state: Maryland
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: