Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Phase 2

Terminated

• Conditions: Persistent Cervical Cancer; Recurrent Cervical Cancer; Metastatic Cervical Cancer; Cervical Cancer
• Interventions: Drug: Cabozantinib 40 MG oral once a day; Drug: Pembrolizumab 200 mg IV every 3 weeks

• Registration Number: NCT04230954
• Lead Sponsor: University of South Alabama

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 Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-04-16
• Primary Completion: 2022-02-16
• Study Completion: 2022-02-16
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabozantinib (XL 184) Plus Pembrolizumab	Cabozantinib 40 MG oral once a day	A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Cabozantinib (XL 184) Plus Pembrolizumab	Pembrolizumab 200 mg IV every 3 weeks	A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	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

Name	Time	Method
Overall Response Rate	Up to 24 months	Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
Cervical Cancer Quality of Life	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.
Overall Survival	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	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

Trial Locations

Locations (1)

University of South Alabama Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States