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Cervical CancerPhase 2NCT04230954

Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

A Phase 2 study testing Cabozantinib 40 MG oral once a day and Pembrolizumab 200 mg IV every 3 weeks in people with Cervical Cancer and Recurrent Cervical Cancer, run by University of South Alabama 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

Drug: Cabozantinib Drug: Pembrolizumab Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cabozantinib 40 MG oral once a day and Pembrolizumab 200 mg IV every 3 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
16 Apr 2020to 16 Feb 2022
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

  • Recurrent or persistent cervical cancer after prior systemic chemotherapy for which there is no curative intent option
  • Documented histologic cervical cancer (acceptable histologies: squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma)
  • Patients must have PD-L1 tumor positivity as defined as CPS>/= 1
  • Age greater than 18 and ECOG performance status of <= 2
  • Adequate organ and marrow function

Who cannot join

  • Prior treatment with cabozantinib or pembrolizumab
  • Receipt of any type of small molecule kinase inhibitor
  • Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery
  • Anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)
Show all 12Show fewer
  • Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias Uncontrolled hypertension despite optimal antihypertensive treatment, stroke
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose
  • Active autoimmune disease requiring systemic therapy within the past 2 years
  • Active infection requiring systemic therapy within the past month
  • History of immunodeficiency

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

Other trials in United States

About this study

Official title: A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Drug: Cabozantinib Drug: Pembrolizumab

Read the detailed description

This study is a multi-center, single arm, open label trial to evaluate the efficacy and safety of Cabozantinib (XL184) plus Pembrolizumab in recurrent, persistent and/or metastatic cervical cancer with PD-L1 tumor positivity.

Being tested
Cabozantinib 40 MG oral once a day, Pembrolizumab 200 mg IV every 3 weeks
Keywords
Recurrent Cervical Cancer, Cervical Cancer, Cervical Carcinoma, PD L1 positivity, Immunotherapy, Squamous Carcinoma, Adenocarcinoma, Adenosquamous Carcinoma
Medical subject headings
Uterine Cervical Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma, Carcinoma, Adenosquamous

What participants receive

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

  • Cabozantinib 40 MG oral once a dayDrug

    Also called Cabometyx

    Cabozantinib 40 mg oral once a day

  • Pembrolizumab 200 mg IV every 3 weeksDrug

    Also called Keytruda

    Pembrolizumab 200 mg IV every 3 weeks

Study groups in NCT04230954
Study groupRoleWhat they receive
Cabozantinib (XL 184) Plus PembrolizumabExperimentalA Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Receives: Drug: Cabozantinib 40 MG oral once a day; Drug: Pembrolizumab 200 mg IV every 3 weeks

What is being measured

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

  1. Progression Free Survival

    Six months progression free survival as defined by RECIST v1.1 measured from signed written consent to the date of first documented tumor progression using RECIST v1.1, or death due to any cause or 24 months after the end of study treatment.

    Measured: Up to 24 months

Secondary outcomes (4)

  1. Overall Response Rate

    Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).

    Measured: Up to 24 months

  2. Overall Survival

    Overall survival will be defined as the time from signed written consent to the date of death or 24 months after the end of study treatment. A patient who has not died will be censored at the last known date of contact

    Measured: Up to 24 months

  3. Incidence of Emergent Adverse Events

    Evaluate the safety and tolerability measured by incidence of adverse events and serious adverse events, deaths, and laboratory abnormalities as measured by Common Terminology Criteria for Adverse Events v.4.0

    Measured: Up to 6 Months

  4. Cervical Cancer Quality of Life

    Quality of life as assessed by FACT Cx quality of life questionnaire. This frequency questionnaire is scaled from 0-4 with 0 being not at all and 4 being very much.

    Measured: Up to 6 Months

Timeline

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

  1. First posted18 Jan 2020
  2. Study start16 Apr 2020
  3. Primary completion16 Feb 2022
  4. Study completion16 Feb 2022

Why it stopped: PI 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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230954
Sponsor's protocol ID
IST-67-MCI-1001
Status last verified
Jun 2022
First submitted
13 Jan 2020
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karim R, Jordanova ES, Piersma SJ, Kenter GG, Chen L, Boer JM, Melief CJ, van der Burg SH. Tumor-expressed B7-H1 and B7-DC in relation to PD-1+ T-cell infiltration and survival of patients with cervical carcinoma. Clin Cancer Res. 2009 Oct 15;15(20):6341-7. doi: 10.1158/1078-0432.CCR-09-1652. Epub 2009 Oct 13.

    PubMed 19825956

  • Yang W, Song Y, Lu YL, Sun JZ, Wang HW. Increased expression of programmed death (PD)-1 and its ligand PD-L1 correlates with impaired cell-mediated immunity in high-risk human papillomavirus-related cervical intraepithelial neoplasia. Immunology. 2013 Aug;139(4):513-22. doi: 10.1111/imm.12101.

    PubMed 23521696

  • Yakes FM, Chen J, Tan J, Yamaguchi K, Shi Y, Yu P, Qian F, Chu F, Bentzien F, Cancilla B, Orf J, You A, Laird AD, Engst S, Lee L, Lesch J, Chou YC, Joly AH. Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther. 2011 Dec;10(12):2298-308. doi: 10.1158/1535-7163.MCT-11-0264. Epub 2011 Sep 16.

    PubMed 21926191

  • Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.

    PubMed 30943124

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib 40 MG oral once a day and Pembrolizumab 200 mg IV every 3 weeks in people with Cervical Cancer and Recurrent Cervical Cancer, run by University of South Alabama 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 5 inclusion and 12 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 7 Jun 2022. 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?

The study was stopped early (reason given: PI left institution). Results are not available in the source record.

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?

Progression Free Survival (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 NCT04230954, which also lists 4 linked publications.

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 7 Jun 2022.

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