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Uterine Cervical NeoplasmsPhase 2NCT02501278

A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer

A Phase 2 study testing INO-3112 vaccine, Radiotherapy (Extrernal beam radiotherapy + brachytherapy) and Cisplatin chemotherapy in people with Uterine Cervical Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Switzerland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to assess the potential benefit of the addition of immunotherapy with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and continued as adjuvant in patients with locally advanced cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
INO-3112 vaccine, Radiotherapy (Extrernal beam radiotherapy + brachytherapy) and Cisplatin chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSwitzerland
Study dates
May 2016to May 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

Main inclusion criteria:

Registration step

  • Age 18 years or older;
  • Newly diagnosed locally advanced cervical cancer defined as FIGO 2009: stage IB2, IIA\&IIB, IIIA\&IIIB or IVA disease;
  • No evidence of distant metastases (Stage IVB);
  • Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix is accepted. Not accepted are small cell, clear cell and other rare variants of the classical adenocarcinoma;
  • Availability of HPV 16 and HPV 18 testing;
  • No HIV seropositive, Hepatitis B or C (unless sustained virologic response achieved by anti-HCV therapy);
  • Written informed consent must be given according to ICH/GCP, and national/local regulations

Randomization step

  • Positive for HPV 16 and/or HPV 18 as assessed by central lab;
  • WHO/ECOG performance status 0 - 2
  • Adequate hematological, liver and renal functions
  • ECG with no clinically significant findings as assessed by the investigator performed within 30 days of signing the informed consent form
  • Absence of current malignancies at other sites, with the exception of 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 five years and are deemed at low risk for recurrence, are eligible for the study;
  • No prior history of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis;
  • No history of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Silgard®, Cervarix®, Gardasil®) are not excluded);
  • No known or suspected hypersensitivity to component(s) of investigational product or cisplatin contraindication (e.g. peripheral neuropathy ≤ grade 2 or ototoxicity ≤ grade 2 as per CTCAE v4);
  • No previous pelvic RT;
  • No previous chemotherapy for this tumor;
  • No patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy;
  • No receipt of any immunotherapy within 4 weeks of start of protocol treatment;
  • No prior major surgery within 4 weeks of randomization from which the patient has not recovered.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

Other trials in Switzerland

About this study

The aim of this study is to assess the potential benefit of the addition of immunotherapy with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and continued as adjuvant in patients with locally advanced cervical cancer.

Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This safety run-in phase will include the first 3 patients treated in each of the two INO-3112 combination arms who are exposed to at least two immunotherapy doses and evaluate whether the combination does not pose undue immediate risks to the patients further enrolled in the trial.

Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant a further phase III conclusive trial based on progression free survival (PFS) at 18 months assessed by RECIST by the local investigator. The efficacy will be assessed within each experimental arm while the standard arm will serve as a reference arm to check the reliability of the results.

Being tested
INO-3112 vaccine, Radiotherapy (Extrernal beam radiotherapy + brachytherapy), Cisplatin chemotherapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • INO-3112 vaccineBiological

    INO-3112 i.e. the combination of VGX-3100 and INO-9012, specifically:

    • VGX-3100 (HPV16 and HPV18 E6-E7 DNA vaccine) will be administered at 3 mg per plasmid (6 mg total DNA)
    • INO-9012 (IL-12 DNA plasmid) will be administered at 1 mg per dose will be administered using the CELLECTRA® electoporation device

  • Radiotherapy (Extrernal beam radiotherapy + brachytherapy)Radiation

    The whole pelvis will be irradiated with 45 - 50.4 Gy in 25-28 fractions in fractions of 1.8 Gy over 5 weeks daily.

    Those patients with pelvis positive and/or para-aortic positive lymph nodes should be treated with an elective dose to the para-aortic area of 45 Gy in fractions of 1.6-1.8 Gy in 25-28 fractions.

    Pelvic and para-aortic nodes known to contain gross/macroscopically visible disease and heavily involved parametria or tumor areas that may lie beyond the high-dose range of brachytherapy should be treated with additional small volume boost of EBRT to a total dose of 60-65 Gy using a combination of either sequential and/or concomitant boost. Fractions of 1.8-2 Gy can be used in the sequential boost.

  • Cisplatin chemotherapyDrug

    Cisplatin chemotherapy will be administered i.v. at a dose of 40 mg/m2 (total 5 cycles during week 1-5) weekly in concomitance with RT with the total dose not to exceed 70 mg per week.

Study groups in NCT02501278
Study groupRoleWhat they receive
Arm A: Immunotherapy during and after CRT + vaccine boostExperimentalINO-3112 dosing during chemoradiotherapy plus immunotherapy dosing after chemoradiotherapy in an adjuvant setting and vaccine boost one year after last vaccine dosing.
Receives: Biological: INO-3112 vaccine; Radiation: Radiotherapy (Extrernal beam radiotherapy + brachytherapy); Drug: Cisplatin chemotherapy
Arm B: Immunotherapy during CRT + vaccine boostExperimentalINO-3112 dosing during chemoradiotherapy, and vaccine boost one year after last vaccine dosing.
Receives: Biological: INO-3112 vaccine; Radiation: Radiotherapy (Extrernal beam radiotherapy + brachytherapy); Drug: Cisplatin chemotherapy
CRT without immunotherapyActive comparatorStandard chemoradiotherapy without immunotherapy
Receives: Radiation: Radiotherapy (Extrernal beam radiotherapy + brachytherapy); Drug: Cisplatin chemotherapy

What is being measured

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

  1. Occurence of Adverse Events

    In order to ensure adequate safety of the combination treatment, a safety run-in will be performed. This safety run-in phase will include the first 3 patients treated in each of the experimental arms (arms A \& B) exposed to at least two immunotherapy doses. The acute safety of the combination of INO-3112 with concomitant CRT will be evaluated similar to a phase I "3+3" safety design. The safety evaluation will be done by the Data Safety Monitoring Board who will invoke an IDMC evaluation of the whole study if undue safety signals are observed.

    Acute toxicity is defined as a grade 3 or more related AEs occurring between the first dose of vaccine administration and up to 14 days after the second dose of immunotherapy. Adverse events are graded according to the NCI CTCAE v4.0. Use of narcotics will be reviewed on case-to-case basis by a medical review team to assess its relevance towards the safety evaluation

    Measured: 6 months

  2. Progression free survival (PFS) at 18 months assessed by RECIST

    Progression Free Survival at 18 months assessed by local investigator

    Measured: 18 months

Timeline

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

  1. First posted17 Jul 2015 (estimated)
  2. Study startMay 2016
  3. Primary completionMay 2019 (estimated)
  4. Study completionMay 2021 (estimated)

Why it stopped: company (Inovio) is no longer able to support the study

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501278
Sponsor's protocol ID
EORTC-1411
Other IDs
2015-004602-42, 2015
Status last verified
May 2016
First submitted
7 Jul 2015
Last updated
13 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INO-3112 vaccine, Radiotherapy (Extrernal beam radiotherapy + brachytherapy) and Cisplatin chemotherapy in people with Uterine Cervical Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02501278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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