Squamous Cell Carcinoma of the Head and NeckPhase 2NCT03325465
Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing Pembrolizumab and Epacadostat in people with Squamous Cell Carcinoma of the Head and Neck, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Pembrolizumab and Epacadostat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 7 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent/assent for the trial.
- Be 18 years of age or older on day of signing informed consent.
- Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy.
- T1N1-N2B, T2-4N0-N2b stage are generally eligible
- If determined per tumor board that a low-volume/non-bulky tumor of another stage is appropriate for resection (e.g. small volume T4 with a small amount of bone invasion) such tumors may also be considered for this study if recommendation in tumor board is such.
- Be appropriate candidates for resection and curative intent therapy in general.
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- Have a performance status of 0 or 1 on the ECOG Performance Scale.
- Consent to undergo biopsy from a newly obtained core or excisional biopsy of a tumor lesion before study drug administration, and during treatment. Biopsy in case of progressive disease is optional.
- Ability to swallow tablets (at future point administration via G-tube may be allowed if approved by drug manufacturer)
- Measurable disease per RECIST 1.1.
- Known HPV status for oropharyngeal primary tumors.
- Pre-operative scans including MRI/CT neck and, CT chest with contrast. If contrast is contraindicated, Staging PET or PET-CT is acceptable although high quality / diagnostic cross-sectional imaging of the head and neck area is recommended.
- Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
- Table 1 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Renal Serum creatinine OR within upper limit of normal (ULN) OR
- Measured or calculateda creatinine clearance ≥60 mL/min for subject with creatinine (GFR can also be used in place of creatinine or levels > institutional ULN CrCl)
- Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
- Albumin >2.5 mg/dL
- Coagulation International Normalized Ratio (INR) or ≤1.5 X ULN unless subject is receiving Prothrombin Time (PT) anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is considered an adequate contraception method.
Who cannot join
- Has a diagnosis now or in the past of immunodeficiency requiring systemic steroid therapy in excess of physiologic dose (or any other form of immunosuppressive therapy within 10 days prior to the first dose of trial treatment).
- Has bulky tumor (define as N3 lymph node or equivalent lymph conglomerate (≥ 6 cm in one dimension), or primary tumor > 4 cm). Cystic HPV+ lymph nodes should be assessed in tumor board and may not be considered bulky.
- Has a known history of active TB (Bacillus Tuberculosis).
- Other life-threatening illness that is expected to impact life expectancy within 3 years.
- Hypersensitivity to pembrolizumab, epacadostat or any of its excipients.
- Has a known additional malignancy that was diagnosed within the last five years that is either progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, or in a broader sense is not felt to impact life-expectancy.
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- Has active autoimmune disease that has required systemic (large physiologic dose) treatment in the past year (i.e. with use of disease modifying agents, corticosteroids or any other immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic immunosuppressive treatment.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis
- Has an active viral infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days of planned start of study therapy.
- Allogeneic organ or stem cell transplant
- History of interstitial lung disease (ILD)/pneumonitis requiring treatment with steroids and patients with active ILD/pneumonitis
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck (SCCHN): The KEO Trial
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.
Read the detailed description
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. Patients that fit the inclusion criteria (see detailed eligibility criteria below) will receive neoadjuvant immunotherapy either with anti-PD-1 (pembrolizumab) alone or anti-PD-1 in combination with IDO1 inhibition (epacadostat). Patients will receive 200 mg IV Pembrolizumab every 3 weeks for up to 3 doses over a period of 8 weeks as well as oral epacadostat 100 mg BID 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 who are unable to safely (or for other reasons unwilling to undergo biopsy at baseline and on treatment 3-4 weeks in for infiltrate assessment are not eligible for the study. MRI is the preferred imaging modality; however, diagnostic CT is acceptable if patient is unable to undergo MRI or as clinically indicated.
Subsequently at week 3-4 an interim assessment will be performed:
- All patients will undergo imaging with a 2nd MRI scan (or CT, to match prior imaging).
- All patients will also undergo repeat mandatory on-treatment biopsy consisting of of 4-6 representative samples to compare to the baseline biopsy. Adequacy of response to treatment will be assessed in assessing eradication of tumor/presence of antitumor tumor response (analogous to reports in lung cancer (Forde et al ESMO 2016). The on-treatment biopsy is essential in the assessment of early response and decision to extend neo-adjuvant treatment to 8 weeks is based in large part on this biopsy. In patients where an on-treatment biopsy is not obtained (e.g no longer considered safe or status of patient has changed), patients will automatically be considered non-complete responders, and take off study after 4 weeks (with the very unlikely but possible exceptions of complete response radiologic response at 4 weeks imaging).
- For exploratory purposes, blood will also be drawn for repeat ctDNA and TCR analysis in order to assess potential suitability of dynamic changes ctDNA or TCR clonality/diversity as candidate biomarkers for follow-up studies.
At the week 3/4 interim assessment, results of the imaging and biopsy will be used to determine response and to determine continuation of immunotherapy induction treatment for up to 8 weeks (full immunotherapy induction course). Patients that demonstrate stable disease or tumor shrinkage radiographically and biopsy demonstrating dense lymphocytic infiltrate with dying tumor / decrease in residual viable tumor will continue on protocol.
Those patients with lack of lymphocytic infiltrate/dying tumor or increasing tumor on radiology (and confirmed on pathology from 2nd biopsy) will be transitioned to standard of care treatment with early salvage surgery or chemoradiation (as clinically indicated).
Pre-surgery assessment: For those patients continuing - a second confirmatory scan will be done 3-4 weeks later again coupled with a blood draw, and followed by surgery at/around week 8 (+/-1 week depending on operating schedules).
Definitive surgery will be done at week 8. Surgical specimens will again be evaluated for percentage residual viable tumor and inflammatory infiltrate. Patients that exhibit complete pathologic response (no viable tumor) will follow close observation with repeat imaging (CT/MRI at 4-6 weeks), clinical exams and a PET scan at 12 weeks post-surgery (as well as serial ctDNA draws (exploratory).
Patients with major pathologic responses (≤10% residual tumor, but tumor present) will be treated with de-escalated adjuvant radiation therapy as determined by the tumor board/radiation oncology.
Patients with a surgical specimen that demonstrates >10% residual tumor after surgery will undergo standard adjuvant RT/CRT as indicated.
Adjuvant Phase: Patients will continue adjuvant pembrolizumab plus epacadostat every 3 weeks for 12 months and be monitored with ctDNA and imaging.
- Being tested
- Pembrolizumab, Epacadostat
- Keywords
- squamous cell carcinoma of the head and neck, head and neck cancer, neoadjuvant pembrolizumab, epacadostat
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
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.
EpacadostatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab and epacadostat | Experimental | 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). Receives: Drug: Pembrolizumab; Drug: Epacadostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major treatment effect (rate of treatment response)
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).
Measured: 3-4 weeks after patient has begun treatment
Rate of complete response
Response rate at surgery compared to historic data with chemotherapy
Measured: 8 weeks after patient has begun treatment
Secondary outcomes (4)
Progression free survival rate
Measured: 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
Measured: 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
Measured: Up to 2 years
Complete response rate
Measured: From the start of treatment to the first documented report of response, disease progression, or death, whichever comes first, not to exceed 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start22 Jan 2018
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
Why it stopped: Site decided not to move forward with trial. Study never opened to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanguy Seiwert, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325465
- Sponsor's protocol ID
- IRB17-0993
- Status last verified
- Apr 2019
- First submitted
- 25 Oct 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck (SCCHN): The KEO Trial
- ClinicalTrials.gov ID
- NCT03325465
- Acronym / sponsor ID
- IRB17-0993
- Keywords
- squamous cell carcinoma of the head and neck, head and neck cancer, neoadjuvant pembrolizumab, epacadostat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site decided not to move forward with trial. Study never opened to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Patients that fit the inclusion criteria (see detailed eligibility criteria below) will receive neoadjuvant immunotherapy either with anti-PD-1 (pembrolizumab) alone or anti-PD-1 in combination with IDO1 inhibition (epacadostat). Patients will receive 200 mg IV Pembrolizumab every 3 weeks for up to 3 doses over a period of 8 weeks as well as oral epacadostat 100 mg BID 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 who are unable to safely (or for other reasons unwilling to undergo biopsy at baseline and on treatment 3-4 weeks in for infiltrate assessment are not eligible for the study. MRI is the preferred imaging modality; however, diagnostic CT is acceptable if patient is unable to undergo MRI or as clinically indicated.
Subsequently at week 3-4 an interim assessment will be performed:
- All patients will undergo imaging with a 2nd MRI scan (or CT, to match prior imaging).
- All patients will also undergo repeat mandatory on-treatment biopsy consisting of of 4-6 representative samples to compare to the baseline biopsy. Adequacy of response to treatment will be assessed in assessing eradication of tumor/presence of antitumor tumor response (analogous to reports in lung cancer (Forde et al ESMO 2016). The on-treatment biopsy is essential in the assessment of early response and decision to extend neo-adjuvant treatment to 8 weeks is based in large part on this biopsy. In patients where an on-treatment biopsy is not obtained (e.g no longer considered safe or status of patient has changed), patients will automatically be considered non-complete responders, and take off study after 4 weeks (with the very unlikely but possible exceptions of complete response radiologic response at 4 weeks imaging).
- For exploratory purposes, blood will also be drawn for repeat ctDNA and TCR analysis in order to assess potential suitability of dynamic changes ctDNA or TCR clonality/diversity as candidate biomarkers for follow-up studies.
At the week 3/4 interim assessment, results of the imaging and biopsy will be used to determine response and to determine continuation of immunotherapy induction treatment for up to 8 weeks (full immunotherapy induction course). Patients that demonstrate stable disease or tumor shrinkage radiographically and biopsy demonstrating dense lymphocytic infiltrate with dying tumor / decrease in residual viable tumor will continue on protocol.
Those patients with lack of lymphocytic infiltrate/dying tumor or increasing tumor on radiology (and confirmed on pathology from 2nd biopsy) will be transitioned to standard of care treatment with early salvage surgery or chemoradiation (as clinically indicated).
Pre-surgery assessment: For those patients continuing - a second confirmatory scan will be done 3-4 weeks later again coupled with a blood draw, and followed by surgery at/around week 8 (+/-1 week depending on operating schedules).
Definitive surgery will be done at week 8. Surgical specimens will again be evaluated for percentage residual viable tumor and inflammatory infiltrate. Patients that exhibit complete pathologic response (no viable tumor) will follow close observation with repeat imaging (CT/MRI at 4-6 weeks), clinical exams and a PET scan at 12 weeks post-surgery (as well as serial ctDNA draws (exploratory).
Patients with major pathologic responses (≤10% residual tumor, but tumor present) will be treated with de-escalated adjuvant radiation therapy as determined by the tumor board/radiation oncology.
Patients with a surgical specimen that demonstrates >10% residual tumor after surgery will undergo standard adjuvant RT/CRT as indicated.
Adjuvant Phase: Patients will continue adjuvant pembrolizumab plus epacadostat every 3 weeks for 12 months and be monitored with ctDNA and imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab and epacadostat | Experimental | Drug: Pembrolizumab, Drug: EpacadostatPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Be willing and able to provide written informed consent/assent for the trial.
- Be 18 years of age or older on day of signing informed consent.
- Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy.
- Be appropriate candidates for resection and curative intent therapy in general.
- Have a performance status of 0 or 1 on the ECOG Performance Scale.
Key exclusion criteria (18 listed)
- Has a diagnosis now or in the past of immunodeficiency requiring systemic steroid therapy in excess of physiologic dose (or any other form of immunosuppressive therapy within 10 days prior to the first dose of trial treatment).
- Has bulky tumor (define as N3 lymph node or equivalent lymph conglomerate (≥ 6 cm in one dimension), or primary tumor > 4 cm). Cystic HPV+ lymph nodes should be assessed in tumor board and may not be considered bulky.
- Has a known history of active TB (Bacillus Tuberculosis).
- Other life-threatening illness that is expected to impact life expectancy within 3 years.
- Hypersensitivity to pembrolizumab, epacadostat or any of its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPatients 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. | Drug | Pembrolizumab and epacadostat |
| EpacadostatPatients 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. | Drug | Pembrolizumab and epacadostat |
Primary outcome
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
4 secondary outcomes
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanguy Seiwert, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Epacadostat in people with Squamous Cell Carcinoma of the Head and Neck, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major treatment effect (rate of treatment response) (time frame: 3-4 weeks after patient has begun treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.