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

University of South Alabama (USA)

Status and phase: Terminated; Phase 2

Conditions: Metastatic Cervical Cancer; Persistent Cervical Cancer; Recurrent Cervical Cancer; Cervical Cancer

Treatments: Drug: Cabozantinib 40 MG oral once a day; Drug: Pembrolizumab 200 mg IV every 3 weeks

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04230954

IST-67-MCI-1001

Details and patient eligibility

About

Drug: Cabozantinib Drug: Pembrolizumab

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Cabozantinib (XL 184) Plus Pembrolizumab

Experimental group

Description:

A Phase II Study of Cabozantinib (XL 184)Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Treatment:

Drug: Pembrolizumab 200 mg IV every 3 weeks

Drug: Cabozantinib 40 MG oral once a day