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

Sponsor

University of South Alabama (Other)

Overall Status

Terminated

CT.gov ID

NCT04230954

Collaborator

Exelixis (Industry)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 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 :

Apr 16, 2020

Actual Primary Completion Date :

Feb 16, 2022

Actual Study Completion Date :

Feb 16, 2022

Arms and Interventions

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 Names: Cabometyx Drug: Pembrolizumab 200 mg IV every 3 weeks Pembrolizumab 200 mg IV every 3 weeks Other Names: Keytruda

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 Names:

Cabometyx

Drug: Pembrolizumab 200 mg IV every 3 weeks

Pembrolizumab 200 mg IV every 3 weeks

Other Names:

Keytruda

Outcome Measures

Primary Outcome Measures

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

Overall Response Rate [Up to 24 months]
Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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