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Trial record 1 of 1 for:    A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab For Recurrent, Persistent and/or Metastatic Cervical Cancer
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Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

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ClinicalTrials.gov Identifier: NCT04230954
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
University of South Alabama

Brief Summary:
Drug: Cabozantinib Drug: Pembrolizumab

Condition or disease Intervention/treatment Phase
Cervical Cancer Recurrent Cervical Cancer Metastatic Cervical Cancer Persistent Cervical Cancer Drug: Cabozantinib 40 MG oral once a day Drug: Pembrolizumab 200 mg IV every 3 weeks Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : January 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Cabozantinib (XL 184) Plus Pembrolizumab
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 day
Cabozantinib 40 mg oral once a day
Other Name: Cabometyx

Drug: Pembrolizumab 200 mg IV every 3 weeks
Pembrolizumab 200 mg IV every 3 weeks
Other Name: Keytruda




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to 24 months ]
    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.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 24 months ]
    Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).

  2. Overall Survival [ Time Frame: Up to 24 months ]
    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

  3. Incidence of Emergent Adverse Events [ Time Frame: Up to 6 Months ]
    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

  4. Cervical Cancer Quality of Life [ Time Frame: Up to 6 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230954


Contacts
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Contact: Wendy Blount, RN, MSN 251-445-9834 wlblount@health.southalabama.edu

Locations
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United States, Alabama
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
Contact: Rodney M Rocconi, M.D.    251-665-8000    rocconi@health.southalabama.edu   
Contact: Wendy Blount, RN, MSN    2514459834    wlblount@health.southalabama.edu   
Sponsors and Collaborators
University of South Alabama
Exelixis
Investigators
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Principal Investigator: Rodney P Rocconi, MD University of South Alabama
Publications:
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Responsible Party: University of South Alabama
ClinicalTrials.gov Identifier: NCT04230954    
Other Study ID Numbers: IST-67-MCI-1001
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of South Alabama:
Recurrent Cervical Cancer
Cervical Cancer
Cervical Carcinoma
PD L1 positivity
Immunotherapy
Squamous Carcinoma
Adenocarcinoma
Adenosquamous Carcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents