A Phase 3 interventional study of Pembrolizumab and Epacadostat in Renal Cell Carcinoma (RCC), sponsored by Incyte Corporation. Completed at 140 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment
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Among 17 studies in Carcinoma, Renal Cell by Incyte Corporation — 1 open to participants now, 1 under way, none of them phase 3. Carcinoma, Renal Cell · Incyte Corporation.
Among the 17 studies in Carcinoma, Renal Cell by Incyte Corporation, this one is the 6th largest by enrollment, is one of 4 that started in 2017, is the only one in phase 3, and was the 9th registered.
2,038 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
Browse Carcinoma, Renal Cell studies →1 of the 17 studies in Carcinoma, Renal Cell by Incyte Corporation is open now, in 5 countries. Recruiting first, the newest first:
Incyte Corporation · Sites in United States, Australia, Belgium and 2 more countries
Ages 18+
By country, each count listing its studies:
Of the 307 Carcinoma, Renal Cell studies recruiting now, 254 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 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.
17 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 9 · Phase 3 1
First in 2014; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 129 is above the median of 43 across 1,565 interventional studies indexed under Carcinoma, Renal Cell.
Median enrollment 100 across the 17 interventional studies. Of the 16 that completed or were terminated, 10 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Carcinoma, Renal Cell by Incyte Corporation, from their registry updates:
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 compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pembrolizumab · Drug: Epacadostat
Standard of care (SoC) (sunitinib or pazopanib monotherapy).
Drug: Sunitinib · Drug: Pazopanib
Pembrolizumab 200 mg administered intravenously every 3 weeks.
Also known as: MK-3475
Epacadostat 100 mg administered orally twice daily.
Also known as: INCB024360
Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
Also known as: Sutent, SU11248
Pazopanib 800 mg administered orally once daily.
Also known as: Votrient
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
Time frame: up to approximately 8 months
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the 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: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug 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: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.
This study was conducted at 73 centers in 14 countries.
| Milestone | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| Started | 64 | 65 |
| Intention-to-treat (itt) | 64 | 65 |
| All subjects as treated (asat) | 64 | 63 |
| Completed | 18 | 46 |
| Not completed | 46 | 19 |
| Withdrew: Death | 6 | 8 |
| Withdrew: Withdrawal by subject | 4 | 11 |
| Withdrew: Transitioned to pembrolizumab monotherapy | 36 | 0 |
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
| percentage of participants | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| Complete Response (CR) | 1.6 (0.0 to 8.4) | 0.0 (0.0 to 5.5) |
| Partial Response (PR) | 29.7 (18.9 to 42.4) | 29.2 (18.6 to 41.8) |
| Objective Response (CR+PR) | 31.3 (20.2 to 44.1) | 29.2 (18.6 to 41.8) |
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 | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs) | 64 | 63 |
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 | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs | 8 | 6 |
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 15 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Epacadostat | 8/64 (12.5%) | 18/64 (28.1%) | 61/64 (95.3%) |
| SoC (Sunitinib or Pazopanib) | 8/65 (12.3%) | 15/63 (23.8%) | 61/63 (96.8%) |
| Event | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| HyponatraemiaMetabolism and nutrition disorders | 1/64 | 2/63 |
| PneumoniaInfections and infestations | 2/64 | 0/63 |
| HypercalcaemiaMetabolism and nutrition disorders | 2/64 | 0/63 |
| Atrial fibrillationCardiac disorders | 1/64 | 1/63 |
| Cardiac failureCardiac disorders | 0/64 | 1/63 |
| Pericardial effusionCardiac disorders | 0/64 | 1/63 |
| DiarrhoeaGastrointestinal disorders | 0/64 | 1/63 |
| Large intestine perforationGastrointestinal disorders | 0/64 | 1/63 |
| NauseaGastrointestinal disorders | 0/64 | 1/63 |
| PancreatitisGastrointestinal disorders | 0/64 | 1/63 |
| Event | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 13/64 | 30/63 |
| HypertensionVascular disorders | 7/64 | 23/63 |
| NauseaGastrointestinal disorders | 22/64 | 20/63 |
| Aspartate aminotransferase increasedInvestigations | 4/64 | 16/63 |
| PruritusSkin and subcutaneous tissue disorders | 16/64 | 1/63 |
| FatigueGeneral disorders | 12/64 | 15/63 |
| Alanine aminotransferase increasedInvestigations | 8/64 | 14/63 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 1/64 | 14/63 |
| AnaemiaBlood and lymphatic system disorders | 10/64 | 12/63 |
| HypothyroidismEndocrine disorders | 9/64 | 12/63 |
The Intention-to-Treat (ITT) population consisted of all randomized participants.
| Age, Continuous(years) | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) | Total |
|---|---|---|---|
| Mean | 62.9 ± 10.9 | 62.1 ± 10.6 | 62.5 ± 10.7 |
| Sex: Female, Male(Participants) | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) | Total |
|---|---|---|---|
| Female | 20 | 15 | 35 |
| Male | 44 | 50 | 94 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) | Total |
|---|---|---|---|
| Hispanic or Latino | 19 | 14 | 33 |
| Not Hispanic or Latino | 43 | 47 | 90 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Race/Ethnicity, Customized(Participants) | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) | Total |
|---|---|---|---|
| American Indian Or Alaska Native | 1 | 0 | 1 |
| Asian | 10 | 9 | 19 |
| White | 53 | 56 | 109 |
| ECOG Performance Scale(Participants) | Pembrolizumab + Epacadostat | SoC (Sunitinib or Pazopanib) | Total |
|---|---|---|---|
| 0 | 41 | 35 | 76 |
| 1 | 23 | 28 | 51 |
| 2 | 0 | 2 | 2 |
Showing the first 100 of 140 sites across 20 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Aug 2018, 8 months.
Results were first posted in Sep 2019, 1 year after primary completion.
Of 35 industry-sponsored phase 3 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 59. This study's 8 months is below that.
Counting every sponsor, half of 61 studies reached it within 56 months; a quarter within 42 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epacadostat