Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer Who Have Failed Platinum Based Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03468218|
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : September 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Head and Neck Carcinoma Paranasal Sinus Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7 Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7 Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7 Unresectable Head and Neck Squamous Cell Carcinoma||Drug: Cabozantinib Biological: Pembrolizumab||Phase 2|
To estimate the overall response rate (ORR) of patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN) who receive the combination of pembrolizumab and cabozantinib.
- To estimate the progression-free survival (PFS) of patients treated with the combination of pembrolizumab and cabozantinib.
- To identify potential biomarkers related to response to the combination of pembrolizumab and cabozantinib in patients with RM SCCHN.
- To evaluate whether markers of angiogenesis, Met or pMet expression, or inflammatory activation can predict response to the combination or PFS.
- To gather exploratory clinical data on a potentially predictive set of biomarkers (potential biomarkers include MET expression by fluorescence in situ hybridization [FISH], next generation sequencing [NGS] and immunohistochemistry [IHC]/immunofluorescence [IHF] of MET proto-oncogene (cMET), phosphorylated cMET (pMET), hepatocyte growth factor (HGF), human epidermal growth factor receptor 2 (HER2), human epidermal growth factor receptor 3 (HER3) and heregulin messenger ribonucleic acid [mRNA] level).
- To further define the toxicities associated with these regimens in patients with SCCHN.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Pembrolizumab and Cabozantinib in Patients With RM SCCHN Who Have Failed Platinum Based Therapy|
|Actual Study Start Date :||September 18, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Treatment (pembrolizumab, cabozantinib)
Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- Overall response rate (ORR) [ Time Frame: Up to 2 years after treatment start ]Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.
- Progression free survival (PFS) [ Time Frame: Duration from date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first, assessed up to 2 years ]The median PFS will be estimated by Kaplan-Meier method along with 95% confidence interval. The biomarker association with PFS will be assessed by the Kaplan-Meier method, log-rank test, and Cox model.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468218
|Contact: Nabil F. Saba, MDemail@example.com|
|United States, Georgia|
|Emory University Hospital Midtown||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Rebecca Holman 404-686-2553 firstname.lastname@example.org|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Shantina Walls 404-778-4995 email@example.com|
|Principal Investigator:||Nabil F. Saba, MD||Emory University|