Vaccine + Chemoradiation for Cervical Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAnn H. Klopp

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA cervical cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. PDS0101 is a type of vaccine that is intended to help the immune system respond to human papillomavirus (HPV16)-infected cervical tumor cells. PDS0101 contains two active components: the first is called R-DOTAP (Versamune) and is included in the vaccine to boost the immune system's response against the HPV viral proteins and the second group of active components are selected small pieces of proteins (called peptides) taken from the HPV virus. Giving PDS0101 in combination with chemoradiation may work help to control cervical cancer.

Eligibility Criteria

This trial is for individuals with newly diagnosed stage IB3-IVA cervical cancer, specifically squamous cell carcinoma. Participants must have a tumor size of at least 5 cm or positive nodal disease and should not have other current malignancies except certain skin cancers. They need to be in good physical condition (ECOG 0-2) and have normal organ function tests. People with HIV, hepatitis B or C, serious infections, recent immunotherapy or steroid use, known allergies to the vaccine components, previous pelvic radiation or chemotherapy for cervical cancer are excluded.

Inclusion Criteria

Creatinine =< 1.5

Alkaline phosphatase (alk phos) =< 2-fold the upper limit of normal

Total bilirubin (total bili) =< 2-fold the upper limit of normal

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Exclusion Criteria

I have had a therapeutic HPV vaccine, not just the preventive ones like Gardasil.

Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the investigator

I have had hepatitis B or C but am cured of hepatitis C.

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Treatment Details

Interventions

Cisplatin (Alkylating agents)
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (Cancer Vaccine)
Radiation Therapy (Radiation)

Trial OverviewThe IMMUNOCERV trial is testing the combination of a new HPV-related vaccine called PDS0101 with standard chemoradiation therapy using cisplatin against advanced cervical cancer. The vaccine aims to boost the immune system's response against HPV-infected tumor cells by including specific protein pieces from the virus.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy, cisplatin, PDS0101)Experimental Treatment3 Interventions

Patients undergo radiation therapy over 1 hour 5 days per week (Monday-Friday) for 5-7 weeks and receive cisplatin IV over 4 hours QW during the 5 weeks of radiation therapy in the absence of disease progression and unacceptable toxicity. Patients also receive PDS0101 SC on days -10, 7, 28, 49, and 170 in the absence of disease progression or unacceptable toxicity.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: