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Cervix Uteri--DiseasesPhase 2NCT03808168

Nivolumab Based Immunotherapy for Treatment of High Grade Cervical Dysplasia

A Phase 2 study testing Nivolumab in people with Cervix Uteri--Diseases, run by University of Texas Southwestern Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study design is a phase II interventional trial for women with biopsy proven high-grade cervical dysplasia. The study is an open label study and randomized. The study will have two arms. Patients will be randomized to both arms. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervix Uteri--Diseases
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jan 2019to 1 Jun 2020
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

Who may be able to join

  • Adult female subjects (age 18 years or older)
  • Performance status ECOG 0-1
  • All patients must have cervical biopsies demonstrating high-grade cervical dysplasia.
  • All patients must have a satisfactory colposcopy with visualization of the entire squamo-columnar junction
  • All patients must be candidates for a cervical conization procedure or LEEP procedure
  • The patient is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed
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  • Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus
  • At least six weeks must have elapsed from any prior chemotherapy, radiation therapy or immunotherapy
  • Patients must have adequate:
  • Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. Platelets greater than or equal to100, 000/mcl. Hemoglobin > 9 gm/dL.
  • Renal function: creatinine less than or equal to institutional upper limit normal (ULN) or calculated creatinine clearance (Cockcroft-Gault) ≥ 50 ml/min.
  • Serum creatinine </= 1.5xULN or creatinine clearance (CrCl) >/=50 mL/min (using the Cockcroft-Gault formula)
  • Female CrCl = (140-age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
  • Metabolic function: Calcium, Magnesium, Phosphate, and Potassium levels within institutional normal limits.
  • Hepatic function: Bilirubin less than or equal to 1.5 x ULN. AST and ALT less than or equal to 3 ULN and alkaline phosphatase less than or equal to 2.5 x ULN.
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception. The effects of Nivolumab on the developing human fetus are unknown. For this reason and because other therapeutic agents or modalities used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, through the duration of study participation and for a period of 5 months after the last dose of nivolumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Who cannot join

  • The patient is lactating or pregnant
  • The colposcopy is inadequate; the entire transformation zone is not visualized and endocervical curettage is positive for high-grade dysplasia
  • Clinical concern for invasive cervical cancer
  • Patients must not have received any prior oncology vaccine therapy
  • Intercurrent medical illnesses that would impair patient tolerance to participation
  • Any concurrent medical condition requiring the use of systemic steroids is not permitted (the use of inhaled or topic steroids is permitted)
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  • Concurrent treatment with chemotherapy, radiation therapy or immunotherapy for intercurrent illnesses
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results;
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
  • Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
  • Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Subjects with history of life-threatening toxicity, including hypersensitivity reaction, related to prior immunoglobulin treatment for another condition or any other study drug component.
  • History or evidence upon physical/neurological examination of other central nervous system condition (e.g., seizures, abscess) unrelated to cancer, unless adequately controlled by medication or considered not potentially interfering with protocol treatment;
  • Surgical procedure <7 days prior to study treatment, vascular access device no restriction;
  • Subjects unable (e.g., due to pacemaker or ICD device) or unwilling to have a contrast-enhanced MRI of the head;
  • History of allergy or hypersensitivity to study drug components
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

About this study

Official title: Phase II Trial of Nivolumab Based Immunotherapy for the Treatment of High-Grade Cervical Dysplasia

The study design is a phase II interventional trial for women with biopsy proven high-grade cervical dysplasia. The study is an open label study and randomized. The study will have two arms. Patients will be randomized to both arms.

Read the detailed description

High-grade cervical dysplasia (cervical intraepithelial neoplasia (CIN) II/III), is both detectable and quantifiable, which presents many opportunities for evaluation or early treatment, intervention and eventually, for cancer prevention. High-grade dysplasia is typically detected during cervical cancer screening with a pap smear. To determine the pathologic response rate of high grade cervical dysplasia with PD-1 checkpoint modulation with Nivolumab.This is a randomized phase II trial with two experimental arms (1 dose of nivolumab and 3 doses of nivolumab).

Being tested
Nivolumab

What participants receive

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

  • NivolumabDrug

    Also called Opdivo, BMS-936558, MDX1106

    Protocol dose: 3mg/kg mg as a 30-minute IV infusion on Day 1 (Arm I) or Days 1, 15, 29 (Arm II).

Study groups in NCT03808168
Study groupRoleWhat they receive
Arm 1Active comparatorNivolumab, 3 mg/kg Iv, day 1
Receives: Drug: Nivolumab
Arm 2Active comparatorNivolumab, 3 mg/kg IV, days 1, 15, 29
Receives: Drug: Nivolumab

What is being measured

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

  1. Rate of regression on high grade dysplasia lesions

    The endpoints of the current study will be to determine the rate of spontaneous regression on high grade dysplasia lesions

    Measured: 15 weeks after the beginning of immunotherapy

Timeline

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

  1. First posted17 Jan 2019
  2. Study start15 Jan 2019 (estimated)
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion1 Jun 2020 (estimated)

Why it stopped: FDA has withdrawn the IND application- requesting protocol changes

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
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03808168
Sponsor's protocol ID
STU 032017-028
Status last verified
Jan 2019
First submitted
15 Jan 2019
Last updated
18 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Cervix Uteri--Diseases, run by University of Texas Southwestern Medical Center.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. 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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Rate of regression on high grade dysplasia lesions (time frame: 15 weeks after the beginning of immunotherapy). 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 NCT03808168.

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 18 Jan 2019.

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