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Cervical CancerPhase 2NCT03367871

Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer

A Phase 2 study testing Pembrolizumab, Paclitaxel and Cisplatin in people with Cervical Cancer, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators propose to evaluate the efficacy of the combination of standard chemotherapy with bevacizumab with Pembrolizumab in women with recurrent, persistent, or metastatic cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Pembrolizumab, Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
6 Sep 2018to 30 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must have histologically confirmed recurrent, persistent or metastatic (primary stage IVB) squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy.
  • All patients must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • Patients must have recovered from effects of recent surgery or radiotherapy or chemoradiotherapy.
  • Patients should be free of active infections requiring antibiotics (with the exception of uncomplicated urinary tract infection).
  • Tissue from an archival sample or newly obtained core or excisional biopsy of a tumor lesion within 6 weeks confirming diagnosis.
  • Age ≥ 18 years
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  • Life expectancy > 3 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) ≥1,500 /microliter (mcL)
  • Platelets ≥ 100,000 / mcL
  • Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency
  • Serum creatinine ≤ 1.5 X upper limit of normal (ULN) OR Measured or calculated a creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. Creatinine clearance should be calculated per institutional standard.
  • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
  • Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
  • Albumin ≥ 2.5 mg/dL
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Negative urine or serum pregnancy ≤72 hours (i.e. 3 days) prior to receiving the first dose of study medication if not surgically sterilized. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential (i.e., have not been surgically sterilized or have not been without menses for >1 year) should be willing to use 2 methods of birth control at the same time, be surgically sterile, or abstain from heterosexual activity for the course of the study and at least 120 days after the last study dose.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last 5 years.
  • Patients who have had prior chemotherapy except when used concurrently with radiation therapy.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervical cancer within the last 5 years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients with an ECOG performance status of 2, 3 or 4.
  • Has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-PD-L2 agent.
  • Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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  • Patients with a known history of human immunodeficiency virus (HIV) or active bacillus tuberculosis (TB).
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • History of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis, or history of pneumonitis requiring treatment.
  • Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment.
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
  • Received live vaccine within 30 days prior to the first dose of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however. intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.
  • Patient with known hypersensitivity to Pembrolizumab or any of its excipients (active ingredients).
  • Patient receiving concurrent additional biologic therapy.
  • Patients who are adults and unable to consent, who are not yet adults, pregnant and nursing women, and prisoners are ineligible.
  • Has an active infection requiring systemic therapy.
  • Thromboembolism (either arterial or venous) within 6 weeks of initiation of treatment.
  • Has significant cardiovascular disease, such as New York Heart Association cardiac disease classification of Class II or greater, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmias, or unstable angina. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician in consultation with a cardiologist if appropriate.
  • Has undergone major surgical procedure within 28 days prior to first Bevacizumab dose or anticipation of the need for a major surgical procedure during the course of the study.
  • Has proteinuria, as demonstrated by urine dipstick or >2.0 g of protein in a urine protein-to creatinine ratio and/or 24 hour (hr) urine collection. All patients with ≥ 2+ protein on dipstick urinalysis at baseline must undergo a urine-to-protein ratio and/or 24 hr urine collection and demonstrate < 2.0 g of protein.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Phase II Single Arm Study of Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

The investigators propose to evaluate the efficacy of the combination of standard chemotherapy with bevacizumab with Pembrolizumab in women with recurrent, persistent, or metastatic cervical cancer.

Conditions
Cervical Cancer
Keywords
Recurrent Cervical Cancer, Persistent Cervical Cancer, Metastatic Cervical Cancer
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.

  • PembrolizumabDrug

    Also called MK-3475, Keytruda

    IV

  • PaclitaxelDrug

    Also called Taxol

    Administered intravenously (IV) on day 1

  • CisplatinDrug

    Also called Platinol

    Administered intravenously (IV) on day 1

  • CarboplatinDrug

    Also called Paraplatin

    Administered intravenously (IV) on day 1

  • BevacizumabDrug

    Also called Avastin

    Administered intravenously (IV) on day 1

Study groups in NCT03367871
Study groupRoleWhat they receive
Pembrolizumab, Chemotherapy, BevacizumabExperimentalOn day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV).
Receives: Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Bevacizumab

What is being measured

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

  1. Objective Response (OR)

    Objective response defined as the percentage of patients showing complete or partial response to study therapy. Response to therapy will be evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    PFS is defined as percentage of participants without disease progression at time of study discontinuation will be assessed.

    Measured: Up to 24 months

  2. Overall Survival (OS)

    The rate of Overall Survival (OS) in study participants at 24 months will be reported. OS is defined as the time from the date of start of treatment until date of death due to any cause or date of last known to be alive. The estimate of OS rate at the 24 months is calculated by the Kaplan-Meier method, which takes into account the censored event-free times.

    Measured: Up to 24 months

  3. Number of Participants Experiencing Treatment-Related Toxicity

    The number of study participants experiencing treatment-related toxicity, including adverse events (AEs) and serious adverse events (SAEs), will be assessed. Treatment-related AEs and SAEs will be evaluated with respect to grade and relationship to treatment, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.

    Measured: Up to 15 months

Timeline

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

  1. First posted11 Dec 2017
  2. Study start6 Sep 2018
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Why it stopped: Investigator left institution

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367871
Sponsor's protocol ID
20170846
Status last verified
May 2024
First submitted
5 Dec 2017
Last updated
18 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Paclitaxel and Cisplatin in people with Cervical Cancer, run by University of Miami at 1 site in United States.

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 21 inclusion and 21 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: stopped early, as of the sponsor's last update on 18 Jun 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response (OR) (time frame: Up to 24 months). 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 NCT03367871.

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 Jun 2024.

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