A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial

Running, not enrolling · Phase 2

Conditions studied: Locally Advanced Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB3 Cervical Cancer FIGO 2018, Stage II Cervical Cancer FIGO 2018, Stage IIA Cervical Cancer FIGO 2018, Stage IIA1 Cervical Cancer FIGO 2018, Stage IIA2 Cervical Cancer FIGO 2018, Stage IIB Cervical Cancer FIGO 2018, Stage III Cervical Cancer FIGO 2018, Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IIIC Cervical Cancer FIGO 2018, Stage IIIC1 Cervical Cancer FIGO 2018, Stage IIIC2 Cervical Cancer FIGO 2018, Stage IVA Cervical Cancer FIGO 2018

In brief

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.

Key facts

Study ID

NCT04580771

Run by

M.D. Anderson Cancer Center

People needed

22

Starts

2020-10-14

Expected to finish

2027-03-08

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Newly diagnosed locally advanced squamous cell carcinoma of cervix (FIGO 2018 stage IB3-IVA with primary tumor ≥ 5 cm and/or positive pelvic or periaortic nodal disease assessed by imaging).
• Histologic diagnosis of squamous cell carcinoma of the cervix.
• Written informed consent before initiation of any study-related procedures;
• WHO/ECOG performance status 0-2.
• Adequate liver (ALT, AST, Alk Phos and total Bili ≤ 2-fold the upper limit of normal), and renal functions (Creatinine ≤ 1.5).
• Absence of current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years and who are deemed at low risk for recurrence are eligible for the study

You may not qualify if…

• HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
• Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response);
• History of clinically significant autoimmune disease, Crohn's disease, or ulcerative colitis
• Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator.
• Receipt of immunotherapy (e.g., IFNs, check-point inhibitors, tumor necrosis factor, interleukins, etc.) or biological response modifiers (GM-CSF, granulocyte colony-stimulating factor, macrophage colony-stimulating factor) within 4 weeks before the first study vaccination.
• Receipt of chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Current or recent use of physiologic doses of intra-articular, topical, or inhaled corticosteroids is acceptable.
• History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines [e.g., Silgard®, Cervarix®, Gardasil®] are not excluded)
• Known or suspected hypersensitivity to any component of the investigational product or contraindications to cisplatin (e.g., peripheral neuropathy grade ≤ 2 or ototoxicity ≤grade 2 per CTCAE v5.0)
• Previous pelvic RT.
• Previous chemotherapy for the cervix tumor
• Previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy
• Prior major surgery within 4 weeks of enrollment from which the patient has not recovered
• Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results
• Concurrent participation in another therapeutic investigational study or use of another investigational drug within 6 months before the first study vaccination
• Previous enrollment in this study
• HPV genotyping is to be done from cervical swab samples. Enrollment will not require HPV testing.
• Pregnancy: a female subject defined as a WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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