Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
NCT ID: NCT04230954
Last Updated: 2022-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2020-04-16
2022-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cabozantinib (XL 184) Plus Pembrolizumab
A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Cabozantinib 40 MG oral once a day
Cabozantinib 40 mg oral once a day
Pembrolizumab 200 mg IV every 3 weeks
Pembrolizumab 200 mg IV every 3 weeks
Interventions
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Cabozantinib 40 MG oral once a day
Cabozantinib 40 mg oral once a day
Pembrolizumab 200 mg IV every 3 weeks
Pembrolizumab 200 mg IV every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Exelixis
INDUSTRY
University of South Alabama
OTHER
Responsible Party
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Principal Investigators
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Stefanie White
Role: STUDY_DIRECTOR
University of South Alabama
Locations
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University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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IST-67-MCI-1001
Identifier Type: -
Identifier Source: org_study_id
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