Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT03325465|
Recruitment Status : Withdrawn (Site decided not to move forward with trial. Study never opened to enrollment.)
First Posted : October 30, 2017
Last Update Posted : April 22, 2019
The KEO study is a single arm phase II trial including 44 patients with T1N1-2B, T2N0-N2B head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent resection (+/- adjuvant therapy), who receive neo-adjvuant pembrolizumab + epacadostat.
The primary objective of this study is to determine rate of major treatment effect (MTE) to neoadjuvant pembrolizumab+epacostat immunotherapy in SCCHN compared to historic data with neoadjuvant pembrolizumab alone.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Pembrolizumab Drug: Epacadostat||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck (SCCHN): The KEO Trial|
|Actual Study Start Date :||January 22, 2018|
|Actual Primary Completion Date :||November 7, 2018|
|Actual Study Completion Date :||November 7, 2018|
Experimental: Pembrolizumab and epacadostat
Patients will receive neoadjuvant immunotherapy either with anti-PD-1 (pembrolizumab) alone or anti-PD-1 in combination with IDO1 inhibition (epacadostat). Patients will receive Pembrolizumab every 3 weeks over a period of 8 weeks as well as epacadostat starting on day 1 for the duration of pembrolizumab treatment.
All patients will undergo baseline biopsy (mandatory, sampling ≥ 4 areas to represent the tumor), as well as baseline imaging (and for exploratory analysis collection of blood for baseline ctDNA testing and TCR analysis).
Patients will receive pembrolizumab alone or pembrolizumab in combination with epacadostat. Pembrolizumab will be administered at 200 mg IV every 3 weeks for up to 3 doses for no longer than 8 weeks prior to surgery. After surgery, patients will continue pembrolizumab plus epacadostat every 3 weeks for 12 months.
Other Name: Keytruda
Patients will receive epacadostat in combination with pembrolizumab. Epacadostat will be administered orally at a dose of 100 mg twice a day starting on day 1 for the duration of pembrolizumab treatment. Patients will continue on this combination for no longer than 8 weeks prior to surgery. After surgery, patients will continue pembrolizumab plus epacadostat every 3 weeks for 12 months.
- Rate of major treatment effect (rate of treatment response) [ Time Frame: 3-4 weeks after patient has begun treatment ]MTE will be assessed in the same way as done by Uppaluri et al (Uppaluri ASCO 2017) upon pathologic review and assessment of 50% resolution of tumor with active immune response (termed "major treatment effect" in their study).
- Rate of complete response [ Time Frame: 8 weeks after patient has begun treatment ]Response rate at surgery compared to historic data with chemotherapy
- Progression free survival rate [ Time Frame: From the start of treatment to the first documented report of disease progression or death, whichever comes first, not to exceed 100 months. ]
- Overall survival rate [ Time Frame: From the start of treatment to the time of death, not to exceed 100 months. ]
- Number of patients with adverse events prior to and after surgery [ Time Frame: Up to 2 years ]
- Complete response rate [ Time Frame: From the start of treatment to the first documented report of response, disease progression, or death, whichever comes first, not to exceed 100 months. ]
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): NCT03325465
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Tanguy Seiwert, MD||University of Chicago|