NCT04230954

Brief Summary

Drug: Cabozantinib Drug: Pembrolizumab

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

January 13, 2020

Last Update Submit

June 3, 2022

Conditions

Cervical CancerRecurrent Cervical CancerMetastatic Cervical CancerPersistent Cervical Cancer

Keywords

Recurrent Cervical CancerCervical CancerCervical CarcinomaPD L1 positivityImmunotherapySquamous CarcinomaAdenocarcinomaAdenosquamous Carcinoma

Outcome Measures

Primary Outcomes (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.

    Up to 24 months

Secondary Outcomes (4)

  • Overall Response Rate

    Up to 24 months

  • Overall Survival

    Up to 24 months

  • Incidence of Emergent Adverse Events

    Up to 6 Months

  • Cervical Cancer Quality of Life

    Up to 6 Months

Study Arms (1)

Cabozantinib (XL 184) Plus Pembrolizumab

EXPERIMENTAL

A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Drug: Cabozantinib 40 MG oral once a dayDrug: Pembrolizumab 200 mg IV every 3 weeks

Interventions

Cabozantinib 40 MG oral once a dayDRUG

Cabozantinib 40 mg oral once a day

Also known as: Cabometyx
Cabozantinib (XL 184) Plus Pembrolizumab
Pembrolizumab 200 mg IV every 3 weeksDRUG

Pembrolizumab 200 mg IV every 3 weeks

Also known as: Keytruda
Cabozantinib (XL 184) Plus Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Related Publications (4)

  • 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.

    PMID: 19825956BACKGROUND

  • 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.

    PMID: 23521696BACKGROUND

  • 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.

    PMID: 21926191BACKGROUND

  • 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.

    PMID: 30943124BACKGROUND

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCarcinoma, Squamous CellAdenocarcinomaCarcinoma, Adenosquamous

Interventions

cabozantinibpembrolizumab

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellNeoplasms, Complex and Mixed

Study Officials

  • Stefanie White

    University of South Alabama

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

April 16, 2020

Primary Completion

February 16, 2022

Study Completion

February 16, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)