Clinical Trials /

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

NCT04230954

Description:

Drug: Cabozantinib Drug: Pembrolizumab

Related Conditions:
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
  • Official Title: A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Clinical Trial IDs

  • ORG STUDY ID: IST-67-MCI-1001
  • NCT ID: NCT04230954

Conditions

  • Cervical Cancer
  • Recurrent Cervical Cancer
  • Metastatic Cervical Cancer
  • Persistent Cervical Cancer

Interventions

DrugSynonymsArms
Cabozantinib 40 MG oral once a dayCabometyxCabozantinib (XL 184) Plus Pembrolizumab
Pembrolizumab 200 mg IV every 3 weeksKeytrudaCabozantinib (XL 184) Plus Pembrolizumab

Purpose

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.
    

Trial Arms

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

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:Up to 24 months
Safety Issue:
Description: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

Measure:Overall Response Rate
Time Frame:Up to 24 months
Safety Issue:
Description:Overall response defined by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 criteria).
Measure:Overall Survival
Time Frame:Up to 24 months
Safety Issue:
Description: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
Measure:Incidence of Emergent Adverse Events
Time Frame:Up to 6 Months
Safety Issue:
Description: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
Measure:Cervical Cancer Quality of Life
Time Frame:Up to 6 Months
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of South Alabama

Trial Keywords

  • Recurrent Cervical Cancer
  • Cervical Cancer
  • Cervical Carcinoma
  • PD L1 positivity
  • Immunotherapy
  • Squamous Carcinoma
  • Adenocarcinoma
  • Adenosquamous Carcinoma

Last Updated

April 23, 2020