Trial record 1 of 1 for:
A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab For Recurrent, Persistent and/or Metastatic Cervical Cancer
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
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Sponsor:
University of South Alabama
Collaborator:
Exelixis
Information provided by (Responsible Party):
University of South Alabama
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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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:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of South Alabama | ||||
Study Sponsor ICMJE | University of South Alabama | ||||
Collaborators ICMJE | Exelixis | ||||
Investigators ICMJE |
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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 |