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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

Tracking Information
First Submitted Date  ICMJE January 13, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE April 16, 2020
Estimated Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
  • Overall Response Rate [ Time Frame: Up to 24 months ]
    Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
  • Overall Response Rate [ Time Frame: Up to 24 months ]
    Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
  • 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
  • Safety and Tolerability [ 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
  • Cervical Cancer Quality of Life [ Time Frame: Up to 6 Months ]
    Quality of life as assessed by EORTC QLQ-CX24 [1] cervical cancer-specific quality of life questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Official Title  ICMJE A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Brief Summary Drug: Cabozantinib Drug: Pembrolizumab
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Cancer
  • Recurrent Cervical Cancer
  • Metastatic Cervical Cancer
  • Persistent Cervical Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Cabozantinib (XL 184) Plus Pembrolizumab
A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Interventions:
  • Drug: Cabozantinib 40 MG oral once a day
  • Drug: Pembrolizumab 200 mg IV every 3 weeks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2020)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 28, 2022
Estimated Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wendy Blount, RN, MSN 251-445-9834 wlblount@health.southalabama.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04230954
Other Study ID Numbers  ICMJE IST-67-MCI-1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of South Alabama
Study Sponsor  ICMJE University of South Alabama
Collaborators  ICMJE Exelixis
Investigators  ICMJE
Principal Investigator: Rodney P Rocconi, MD University of South Alabama
PRS Account University of South Alabama
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP