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

• Status: Recruiting
• Trial end date: 2022-01-28
• Target enrollment: 0
• Participant gender: Female

Summary

Drug: Cabozantinib Drug: Pembrolizumab

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Alabama
• Collaborator: Exelixis
• Treatments: Pembrolizumab

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