Facebook

Twitter

Linkedin

Pinterest

Email

Clinical Trials Search

Back to Search Results

Clinical Trial 19570

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT03468218

Phase: Phase II
Principal Investigator: Chung, Christine

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase II Trial of Pembrolizumab and Cabozantinib in Patients with RM SCCHN

Summary

This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.

Objective

Primary Objectives: Run in phase: To determine the safety and tolerability of pembrolizumab and cabozantanib in patients with recurrent and/or metastatic SCCHN who have failed platinum and cetuximab. Phase II: To estimate the overall response rate (ORR) of patients with RM SCCHN who receive the combination of pembrolizumab and cabozantanib Secondary Objectives: To estimate the progression free survival of patients treated with the combination of pembrolizumab and cabozantanib To identify potential biomarkers related to response to the combination of pembrolizumab and cabozantanib in patients recurrent and/or metastatic SCCHN. Specifically, to evaluate whether markers of angiogenesis, Met or pMet expression, or inflammatory activation can predict response to the combination or PFS

Treatments

Therapies

Therapy (NOS)

Medications

Cabozantinib (XL 184); Pembrolizumab (Keytruda)

Inclusion Criteria

Histologic or cytologic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, paranasal sinuses, hypopharynx, nasopharynx, or larynx; squamous cell carcinoma of unknown primary in cervical lymph node can be included only if human papillomavirus (HPV) status is positive

Refractory, recurrent or metastatic disease, which is deemed to be inoperable.

Must have failed platinum based therapy; if patients were found to be intolerant of standard first line systemic chemotherapy, patients are eligible to enroll to this study provided platinum based therapy was administered prior to enrollment

In case patients received prior systemic therapy within the definitive or metastatic setting, disease progression must be documented following prior therapy; this can be in the recurrent or metastatic setting following platinum or in the concurrent setting

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the investigator

A maximum of one prior radiotherapy regimen, curative or palliative, to the head and neck is allowed; if the radiation is combined with chemotherapy, a minimum of 4 months must elapse between the end of radiotherapy and registration; if the radiation is given alone, a minimum of 8 weeks must elapse between the end of radiotherapy and registration; a minimum of 3 weeks must elapse between prior radiation to other areas and registration; treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation

Has had an assessment of all known disease sites e.g., by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan or positron emission tomography (PET)/CT scan as appropriate, within 28 days before the first dose of cabozantinib

Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy

Participant is capable of understanding and complying with the protocol requirements and has signed the informed consent document

Sexually active participants (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all participants of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)

Female participants of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons

Other criteria may apply

Exclusion Criteria

Patients who have HPV negative squamous cell carcinoma of unknown primary in cervical lymph node

Participant has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment

Prior treatment with cabozantinib or pembrolizumab

Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment; systemic treatment with radionuclides within 6 weeks before the first dose of study treatment; participants with clinically relevant ongoing complications from prior radiation therapy are not eligible

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment

The participant has received any other type of investigational agent within 28 days or 5 half-lives, whichever is shorter, before the first dose of study treatment

Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment; eligible participants must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment

The participant has prothrombin time (PT)/institutional normalized ratio (INR) or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g.; warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (e.g.; clopidogrel). Some exceptions apply.

The participant has experienced any of the following: Clinically-significant GI bleeding within 6 months before the first dose of study treatment, Hemoptysis of ≥ 0.5 teaspoon (2.5 ml) of red blood within 3 months before the first dose of study treatment, or Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment

Radiographic evidence of cavitating pulmonary lesion(s)

Tumor invading or encasing any major blood vessels

Evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib

Uncontrolled, significant intercurrent or recent illness including, but not limited to, conditions noted per protocol.

Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment; minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; participants with clinically relevant ongoing complications from prior surgery are not eligible

Corrected QT interval by Fridericia's formula (QTcF) > 500 msec within 1 month before the first dose of study treatment

Pregnant or lactating females

Inability to swallow intact tablets or inability to take pembrolizumab or cabozantinib

Previously identified allergy or hypersensitivity to components of the study treatment formulations

Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 1 year post diagnosis; patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.