Description:
Drug: Cabozantinib Drug: Pembrolizumab
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
Drug | Synonyms | Arms |
---|
Cabozantinib 40 MG oral once a day | Cabometyx | Cabozantinib (XL 184) Plus Pembrolizumab |
Pembrolizumab 200 mg IV every 3 weeks | Keytruda | Cabozantinib (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
Name | Type | Description | Interventions |
---|
Cabozantinib (XL 184) Plus Pembrolizumab | Experimental | 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
- 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
August 20, 2020