Cervical Cancer, Metastatic Cervical Cancer, Persistent Cervical Cancer, Recurrent Cervical Cancer
Conditions
Keywords
Recurrent Cervical Cancer, Cervical Cancer, Cervical Carcinoma, PD L1 positivity, Immunotherapy, Squamous Carcinoma, Adenocarcinoma, Adenosquamous Carcinoma
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.
Interventions
DRUGCabozantinib 40 MG oral once a day
Cabozantinib 40 mg oral once a day
DRUGPembrolizumab 200 mg IV every 3 weeks
Pembrolizumab 200 mg IV every 3 weeks
Sponsors
Exelixis
University of South Alabama
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed