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Locally Advanced Cervical Squamous Cell Carcinoma, Not Otherwise SpecifiedPhase 2NCT04580771

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

A Phase 2 study testing Cisplatin, Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 and Radiation Therapy in people with Locally Advanced Cervical Squamous Cell Carcinoma, Not Otherwise Specified and Stage IB3 Cervical Cancer FIGO 2018, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cisplatin, Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
14 Oct 2020to 8 Mar 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: IMMUNOCERV: Evaluating the Safety of Chemoradiation Combined With PDS0101 Immunotherapy in Treating Locally Advanced Cervical Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate the safety and toxicity profile of delivering the immune nanoparticle liposomal HPV-16 E6/E7 multipeptide vaccine PDS0101 (PDS0101) with standard-of-care chemoradiation (chemoRT) in patients with locally advanced cervical cancer.

SECONDARY OBJECTIVES:

  1. Rate of complete metabolic response on day 170 (+/- 14 days) positron emission tomography computed tomography (PET CT).

II. Rate of >= 90% gross tumor volume reduction day 35 magnetic resonance imaging (MRI) (+/- 5 days).

III. Report rates of local control (LC), progression-free survival (PFS), and overall survival (OS) at 12 and 18 months following chemoRT completion.

IV. Long-term safety: rate of grade >= 3 chronic toxicity (from day 81 to completion of trial).

EXPLORATORY HPV-SPECIFIC IMMUNE RESPONSE OBJECTIVES:

  1. Enzyme-linked immunosorbent spot (ELISpot) assays on interferon-gamma and granzyme B levels in E6/7-specific T cells isolated from peripheral blood mononuclear cells (PBMCs).

II. Compare intratumoral T-cell receptor (TCR) clonality at baseline and end of treatment by TCR sequencing.

III. Measure CD4+ and CD8+ tumor-infiltrating lymphocytes (TILs) from cervical brush samples by using markers of T-cell exhaustion (PD1, CTLA4) and T cell-activation (granzyme B, CD69+).

IV. Assess the intestinal and cervical microbiome by analyzing rectal and cervical swab samples with 16s ribosomal ribonucleic acid (rRNA) sequencing.

  1. Additional assays such as circulating tumor cells, circulating cell-free tumor deoxyribonucleic acid (DNA) (ccfDNA), and other assays will be performed at the discretion of the principal investigator.

OUTLINE:

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

After completion of study treatment, patients are followed up at 30 days, 1, 4, 6, 12, and 18 weeks, and 18 months.

Being tested
Cisplatin, Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101Biological

    Also called mmunoMAPK-RDOTAP /HPV-16 E6/E7 Peptide Antigen Vaccine, PDS0101

    Given SC

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation

    Undergo radiation therapy

Study groups in NCT04580771
Study groupRoleWhat they receive
Treatment (radiation therapy, cisplatin, PDS0101)ExperimentalPatients 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.
Receives: Drug: Cisplatin; Biological: Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of grade >= 3 acute toxicity

    Measured from first vaccine injection up to 30 days following completion of chemoradiotherapy (chemoRT). Adverse events (AEs) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Any AE that occurs between the first day of PDS0101 injection and up to 30 days following completion of chemoRT (~Day 80) will be considered as acute toxicity (AT).

    Measured: Day -10 to day 80

Secondary outcomes (6)

  1. Rate of complete metabolic response

    Measured by positron emission tomography computed tomography (PET CT).

    Measured: Day 170

  2. Rate of >= 90% gross tumor volume reduction

    Measured by magnetic resonance imaging (MRI).

    Measured: Day 35

  3. Rates of local control

    Will be represented by Kaplan-Meier curves.

    Measured: At 12 and 18 months

  4. Rates of progression-free survival

    Will be represented by Kaplan-Meier curves.

    Measured: At 12 and 18 months

  5. Rates of overall survival

    Will be represented by Kaplan-Meier curves.

    Measured: At 12 and 18 months

  6. Rate of grade >= 3 chronic toxicity

    AEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Chronic toxicity (CT) is any toxicity that occurs outside of the AT window (between Days 81 and study completion of the study).

    Measured: Day 81 to completion of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start14 Oct 2020
  3. Primary completion8 Mar 2027 (estimated)
  4. Study completion8 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580771
Sponsor's protocol ID
2019-1260
Other IDs
NCI-2020-06810, 2019-1260
Status last verified
Apr 2026
First submitted
5 Oct 2020
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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