A Phase 3 interventional study of Pembrolizumab and Epacadostat in Head and Neck Cancer, sponsored by Incyte Corporation. Completed at 73 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment
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Among 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck — 17 open to participants now, 31 under way, 2 of them phase 3. pembrolizumab · Squamous Cell Carcinoma of Head and Neck.
Among the 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck, this one is the 21st largest by enrollment, is one of 7 that started in 2017, is one of 5 in phase 3, and was the 19th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →17 of the 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck are open now, in 5 countries. Recruiting first, the newest first:
Brown University · Sites in United States
Ages 65+
Emory University · Sites in United States
Ages 18+
National University Hospital, Singapore · Sites in Singapore
Ages 21–99
University of Leipzig · Sites in Germany
Ages 18–70
University of California, Davis · Sites in United States
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
62 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 46 · Phase 3 5 · Phase 4 1
First in 2014; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 89 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 52 across the 62 interventional studies. Of the 28 that completed or were terminated, 18 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 62 have an industry lead sponsor. The 10 most frequent:
Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
14 studies in Squamous Cell Carcinoma of Head and Neck by Incyte Corporation: none open now, none under way, none of them phase 3. Of 12 finished, 7 (58%) have results posted.
Among the 14 studies in Squamous Cell Carcinoma of Head and Neck by Incyte Corporation, this one is the 3rd largest by enrollment, is one of 5 that started in 2017, is one of 2 in phase 3, and was the 6th registered.
Incyte Corporation’s Squamous Cell Carcinoma of Head and Neck studies by the year they started, since 2017.
9 of the studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06998069Phase 3Brown UniversityHead and Neck Cancer Study Project in the Geriatric Population | 2026-12-01 |
| NCT06102395Phase 3Beijing Tongren HospitalEvaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC | 2027-04-30 |
| NCT06580054University of Michigan Rogel Cancer CenterPembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma | 2026-12 |
| NCT06211335University of California, DavisLosartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma | 2026-12 |
| NCT04754321Ohio State University Comprehensive Cancer CenterCombining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck, from their registry updates:
Among Incyte Corporation’s 14 in Squamous Cell Carcinoma of Head and Neck:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 89 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Head and Neck Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pembrolizumab · Drug: Epacadostat
Drug: Pembrolizumab
EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.
Drug: Cetuximab · Drug: Cisplatin · Drug: Carboplatin · Drug: 5-Fluorouracil
Pembrolizumab administered intravenously every 3 weeks.
Also known as: MK-3475
Epacadostat administered orally twice daily.
Also known as: INCB024360
Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.
Cisplatin administered intravenously every 3 weeks for \</= 6 cycles.
Carboplatin administered intravenously every 3 weeks for \</= 6 cycles.
5-Fluorouracil administered intravenously every 3 weeks for \</= 6 cycles.
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination. Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans.
Time frame: Minimum Week 9
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: up to approximately 8 years
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: up to approximately 8 years
| Milestone | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME |
|---|---|---|---|
| Started | 35 | 19 | 35 |
| Intention-to-treat (itt) | 35 | 19 | 35 |
| All participants as treated (apat) | 34 | 19 | 34 |
| Completed | 24 | 12 | 22 |
| Not completed | 11 | 7 | 13 |
| Withdrew: Death | 9 | 5 | 12 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
| Withdrew: Sponsor decision | 2 | 0 | 0 |
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination. Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans.
| percentage of participants | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME |
|---|---|---|---|
| Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen | 31.4 (16.9 to 49.3) | 21.1 (6.1 to 45.6) | 34.3 (19.1 to 52.2) |
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Participants | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME |
|---|---|---|---|
| Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs) | 34 | 17 | 34 |
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Participants | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME |
|---|---|---|---|
| Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs | 6 | 3 | 9 |
Collected over Non-serious adverse events were reported from start of study, up to 30 days after last dose and serious adverse events up to 90 days after last dose are included, up to approximately 8 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Epacadostat | 9/35 (25.7%) | 14/34 (41.2%) | 34/34 (100%) |
| Pembrolizumab | 5/19 (26.3%) | 9/19 (47.4%) | 17/19 (89.5%) |
| EXTREME | 12/35 (34.3%) | 13/34 (38.2%) | 34/34 (100%) |
| Event | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME |
|---|---|---|---|
| PneumoniaInfections and infestations | 3/34 | 1/19 | 1/34 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/34 | 0/19 | 2/34 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/34 | 0/19 | 0/34 |
| Atrioventricular block completeCardiac disorders | 0/34 | 1/19 | 0/34 |
| Myocardial infarctionCardiac disorders | 0/34 | 1/19 | 0/34 |
| DiarrhoeaGastrointestinal disorders | 0/34 | 1/19 | 0/34 |
| CholangitisHepatobiliary disorders | 0/34 | 1/19 | 1/34 |
| Hepatic function abnormalHepatobiliary disorders | 0/34 | 1/19 | 0/34 |
| Bacterial infectionInfections and infestations | 0/34 | 1/19 | 0/34 |
| EmpyemaInfections and infestations | 0/34 | 1/19 | 0/34 |
| Event | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 6/34 | 4/19 | 19/34 |
| NauseaGastrointestinal disorders | 6/34 | 2/19 | 17/34 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 1/34 | 0/19 | 14/34 |
| NeutropeniaBlood and lymphatic system disorders | 0/34 | 0/19 | 13/34 |
| ConstipationGastrointestinal disorders | 6/34 | 2/19 | 13/34 |
| Platelet count decreasedInvestigations | 1/34 | 0/19 | 13/34 |
| RashSkin and subcutaneous tissue disorders | 9/34 | 5/19 | 13/34 |
| FatigueGeneral disorders | 11/34 | 4/19 | 8/34 |
| HypomagnesaemiaMetabolism and nutrition disorders | 2/34 | 0/19 | 11/34 |
| Mucosal inflammationGeneral disorders | 0/34 | 0/19 | 10/34 |
Intention-to-Treat (ITT) population consisted of all randomized participants.
| Age, Customized(years) | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME | Total |
|---|---|---|---|---|
| Mean | 62.1 ± 9.0 | 63.0 ± 9.6 | 62.7 ± 10.0 | 62.5 ± 9.4 |
| Sex: Female, Male(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME | Total |
|---|---|---|---|---|
| Female | 5 | 3 | 6 | 14 |
| Male | 30 | 16 | 29 | 75 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 34 | 17 | 35 | 86 |
| Unknown or Not Reported | 1 | 2 | 0 | 3 |
| Race/Ethnicity, Customized(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME | Total |
|---|---|---|---|---|
| Asian | 6 | 5 | 13 | 24 |
| Black Or African American | 1 | 0 | 0 | 1 |
| White | 28 | 14 | 22 | 64 |
| Primary Tumor Site(Participants) | Pembrolizumab + Epacadostat | Pembrolizumab | EXTREME | Total |
|---|---|---|---|---|
| Oropharynx | 12 | 6 | 12 | 30 |
| Oral Cavity | 10 | 5 | 7 | 22 |
| Larynx | 9 | 5 | 7 | 21 |
| Hypopharynx | 4 | 3 | 9 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Jul 2018, 7 months.
Results were first posted in Sep 2019, 1 year 1 month after primary completion.
Of 78 phase 3 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 117. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pembrolizumab · Epacadostat
Squamous Cell Carcinoma of Head and Neck →