A Phase 1/2 interventional study of MK-3475 and INCB024360 in Microsatellite-instability (MSI) High Colorectal Cancer (CRC), Endometrial Cancer and Head and Neck Cancer, sponsored by Incyte Corporation. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-14.
Sponsored by Incyte Corporation · Phase 1/2, Interventional, and Treatment
The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.
52 studies on the registry are indexed under Microsatellite Instability; 10 are open to participants now.
This study's enrollment of 444 is above the median of 49 across 28 interventional studies indexed under Microsatellite Instability.
Browse Microsatellite Instability 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.
Counted across the registry records on this site, refreshed daily.
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.
For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma ( naïve, primary melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, TNBC, gastric cancer, and HCC.
Phase 2 expansion: NSCLC
Phase 2 expansion: Melanoma
Phase 2 expansion: Transitional cell carcinoma of the GU tract
Phase 2 expansion: SCCHN
Phase 2 expansion: Ovarian cancer
Phase 2 expansion: Relapsed or refractory DLBCL
Phase 2 expansion: TNBC
Phase 2 expansion: RCC
Phase 2 expansion: MSI high CRC
Phase 2 expansion: Gastric Cancer
Phase 2 expansion: HCC
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 diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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 line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 1: MK-3475 + INCB024360 25 mg twice a day (BID) as starting dose, followed by dose escalations (Phase 1) until recommended phase 2 dose of INCB024360 is determined
Drug: MK-3475 · Drug: INCB024360
(recommended phase 2 dose)
Drug: MK-3475 · Drug: INCB024360
IV infusion
Oral daily dosing
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
Time frame: Approximately 54 months
Phase 2: Objective Response Rate (ORR)
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Approximately 54 months
Phase 2: Duration of Response (DOR)
Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.
Time frame: Up to 54 months
Phase 2: Progression Free Survival (PFS)
Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.
Time frame: Up to 54 months
Phase 2: Duration of Disease Control
The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.
Time frame: Up to 54 months
Phase 2: Overall Survival (OS)
Overall survival is determined from the date of first dose until death due to any cause.
Time frame: Up to 54 months
Phase 2: Ordinal Categorical Response Score
Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1
Time frame: Up to 54 months
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
Time frame: Up to 54 months
Participants took part in the study at 22 investigative sites in the United States from 17July 2014 to 06 November 2020.
| Milestone | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 mg BID | Phase 1: Epacadostat 100 mg BID | Phase 1: Epacadostat 300 mg BID | Phase 2: Epacadostat 100 mg BID |
|---|---|---|---|---|---|
| Started | 4 | 20 | 18 | 20 | 382 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 20 | 18 | 20 | 382 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 | 33 |
| Withdrew: Death | 2 | 13 | 12 | 12 | 205 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 2 | 11 |
| Withdrew: Study terminated by sponsor | 2 | 7 | 6 | 4 | 128 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 3 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 2 |
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
| Percentage of Participants | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 mg BID | Phase 1: Epacadostat 100 mg BID | Phase 1: Epacadostat 300 mg BID |
|---|---|---|---|---|
| SAE | 0 | 40.0 | 50.0 | 45.0 |
| TEAS | 100. | 95.0 | 94.4 | 100. |
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| percentage of participants | Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W |
|---|---|
| Triple negative breast cancer | 11.1 |
| Microsatellite-instability high colorectal cancer | 43.8 |
| Gastric cancer | 22.2 |
| Hepatocellular carcinoma | 16.7 |
| Melanoma - immune checkpoint-naïve | 60.5 |
| Non-small cell lung cancer (NSCLC) (tumor proportion score (TPS) < 50% or indeterminate) | 30.8 |
| NSCLC programmed cell death ligand (PD-L1) low negative (TPS < 50%) | 24.4 |
| Ovarian cancer | 8.1 |
| Renal cell carcinoma | 32.4 |
| Squamous cell carcinoma of the head and neck | 33.3 |
| Transitional carcinoma of the genitourinary (GU) tract | 30.6 |
| Diffuse large B-cell lymphoma | 19.2 |
| Primary Refractory Melanoma | 0.0 |
| Relapsed Melanoma | 0.0 |
Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.
| Months | Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W |
|---|---|
| Hepatocellular Carcinoma | NA (2.04 to NA) |
| Triple Negative Breast Cancer | NA (0.92 to NA) |
| Immune Checkpoint-naïve Melanoma | NA (26.35 to NA) |
| NSCLC high positive (PD-L1 TPS ≥ 50%) | 12.44 (2.10 to 16.53) |
| NSCLC low/negative or indeterminate (PD-L1 TPS < 50% or indeterminate) | 11.93 (8.90 to 14.95) |
| NSCLC (TPS 0%) | NA (7.43 to NA) |
| NSCLC Unknown | 10.84 (4.14 to NA) |
| Renal Cell Carcinoma | 16.95 (12.58 to NA) |
| Squamous Cell Carcinoma of the Head and Neck | 11.33 (3.94 to 31.74) |
| Transitional Cell Carcinoma of the GU Tract | NA (10.64 to NA) |
| Ovarian Cancer | NA (5.75 to NA) |
| Gastric Cancer | NA (0.46 to NA) |
| MSI high Colorectal Cancer | NA (4.17 to NA) |
| DLBCL | 3.66 (0.72 to NA) |
Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.
| Months | Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W |
|---|---|
| Hepatocellular Carcinoma | 5.49 (2.69 to 10.28) |
| Triple Negative Breast Cancer | 1.97 (1.87 to 2.92) |
| Immune Checkpoint-naïve Melanoma | 16.69 (6.24 to NA) |
| Primary Refractory Melanoma | 1.69 (1.25 to 2.14) |
| Relapsed Melanoma | 2.60 (2.14 to 4.21) |
| NSCLC | 4.09 (2.14 to 7.36) |
| Renal Cell Carcinoma | 4.50 (2.33 to 6.24) |
| Squamous Cell Carcinoma of the Head and Neck | 4.37 (2.30 to 7.79) |
| Transitional Cell Carcinoma of the GU Tract | 4.40 (2.14 to 8.90) |
| Ovarian Cancer | 2.10 (1.97 to 2.83) |
| Gastric Cancer | 1.97 (1.41 to 2.07) |
| MSI high Colorectal Cancer | 6.11 (2.07 to NA) |
| DLBCL | 2.63 (1.87 to 4.01) |
The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.
| Months | Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W |
|---|---|
| Hepatocellular Carcinoma | 10.38 (5.49 to NA) |
| Triple Negative Breast Cancer | 11.47 (4.01 to 12.65) |
| Immune Checkpoint-naïve Melanoma | 30.29 (25.03 to NA) |
| Relapsed Melanoma | 4.21 (NA to NA) |
| NSCLC Total | 14.42 (8.51 to 19.45) |
| Renal Cell Carcinoma | 13.39 (5.13 to 18.86) |
| Squamous Cell Carcinoma of the Head and Neck | 9.18 (6.24 to 13.34) |
| Transitional Cell Carcinoma of the GU Tract | 15.36 (8.41 to 22.74) |
| Ovarian Cancer | 5.08 (3.29 to 7.79) |
| Gastric Cancer | NA (2.56 to NA) |
| MSI high Colorectal Cancer | NA (6.11 to NA) |
| DLBCL | 7.29 (4.01 to 10.91) |
Overall survival is determined from the date of first dose until death due to any cause.
| Months | Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W |
|---|---|
| Hepatocellular Carcinoma | NA (8.94 to NA) |
| Triple Negative Breast Cancer | 5.16 (4.60 to 7.46) |
| Immune Checkpoint-naïve Melanoma | NA (NA to NA) |
| Primary Refractory Melanoma | NA (NA to NA) |
| Relapsed Melanoma | NA (2.60 to NA) |
| NSCLC | 14.62 (9.72 to 24.38) |
| Renal Cell Carcinoma | NA (18.40 to NA) |
| Squamous Cell Carcinoma of the Head and Neck | 8.34 (4.37 to 15.41) |
| Transitional Cell Carcinoma of the GU Tract | 13.44 (8.41 to NA) |
| Ovarian Cancer | 13.11 (8.34 to 25.92) |
| Gastric Cancer | 4.04 (1.97 to 15.84) |
| MSI high Colorectal Cancer | NA (8.15 to NA) |
| DLBCL | 11.79 (4.37 to NA) |
Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1
| Participants | Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W |
|---|---|
| Hepatocellular Carcinoma — Complete Response - Score 1 | 0 |
| Hepatocellular Carcinoma — Very Good Response - Score 2 | 2 |
| Hepatocellular Carcinoma — Minor Response - Score 3 | 2 |
| Hepatocellular Carcinoma — Stable Disease - Score 4 | 11 |
| Hepatocellular Carcinoma — Progressive Disease - Score 5 | 8 |
| Hepatocellular Carcinoma — Unable to Evaluable | 1 |
| Triple Negative Breast Cancer — Complete Response - Score 1 | 1 |
| Triple Negative Breast Cancer — Very Good Response - Score 2 | 1 |
| Triple Negative Breast Cancer — Minor Response - Score 3 | 2 |
| Triple Negative Breast Cancer — Stable Disease - Score 4 | 7 |
| Triple Negative Breast Cancer — Progressive Disease - Score 5 | 19 |
| Triple Negative Breast Cancer — Unable to Evaluable | 6 |
| Immune Checkpoint-naïve Melanoma — Complete Response - Score 1 | 3 |
| Immune Checkpoint-naïve Melanoma — Very Good Response - Score 2 | 17 |
| Immune Checkpoint-naïve Melanoma — Minor Response - Score 3 | 6 |
| Immune Checkpoint-naïve Melanoma — Stable Disease - Score 4 | 5 |
| Immune Checkpoint-naïve Melanoma — Progressive Disease - Score 5 | 10 |
| Immune Checkpoint-naïve Melanoma — Unable to Evaluable | 2 |
| Primary Refractory Melanoma — Complete Response - Score 1 | 0 |
| Primary Refractory Melanoma — Very Good Response - Score 2 | 0 |
| Primary Refractory Melanoma — Minor Response - Score 3 | 0 |
| Primary Refractory Melanoma — Stable Disease - Score 4 | 0 |
| Primary Refractory Melanoma — Progressive Disease - Score 5 | 2 |
| Primary Refractory Melanoma — Unable to Evaluable | 1 |
| Relapsed Melanoma — Complete Response - Score 1 | 3 |
| Relapsed Melanoma — Very Good Response - Score 2 | 4 |
| Relapsed Melanoma — Minor Response - Score 3 | 5 |
| Relapsed Melanoma — Stable Disease - Score 4 | 8 |
| Relapsed Melanoma — Progressive Disease - Score 5 | 10 |
| Relapsed Melanoma — Unable to Evaluable | 6 |
| NSCLC — Complete Response - Score 1 | 4 |
| NSCLC — Very Good Response - Score 2 | 3 |
| NSCLC — Minor Response - Score 3 | 8 |
| NSCLC — Stable Disease - Score 4 | 15 |
| NSCLC — Progressive Disease - Score 5 | 24 |
| NSCLC — Unable to Evaluable | 4 |
| Renal Cell Carcinoma — Complete Response - Score 1 | 2 |
| Renal Cell Carcinoma — Very Good Response - Score 2 | 6 |
| Renal Cell Carcinoma — Minor Response - Score 3 | 4 |
| Renal Cell Carcinoma — Stable Disease - Score 4 | 10 |
| Renal Cell Carcinoma — Progressive Disease - Score 5 | 13 |
| Renal Cell Carcinoma — Unable to Evaluable | 2 |
| Squamous Cell Carcinoma of the Head and Neck — Complete Response - Score 1 | 3 |
| Squamous Cell Carcinoma of the Head and Neck — Very Good Response - Score 2 | 4 |
| Squamous Cell Carcinoma of the Head and Neck — Minor Response - Score 3 | 5 |
| Squamous Cell Carcinoma of the Head and Neck — Stable Disease - Score 4 | 8 |
| Squamous Cell Carcinoma of the Head and Neck — Progressive Disease - Score 5 | 10 |
| Squamous Cell Carcinoma of the Head and Neck — Unable to Evaluable | 6 |
| Transitional Cell Carcinoma of the GU Tract — Complete Response - Score 1 | 2 |
| Transitional Cell Carcinoma of the GU Tract — Very Good Response - Score 2 | 4 |
| Transitional Cell Carcinoma of the GU Tract — Minor Response - Score 3 | 5 |
| Transitional Cell Carcinoma of the GU Tract — Stable Disease - Score 4 | 10 |
| Transitional Cell Carcinoma of the GU Tract — Progressive Disease - Score 5 | 11 |
| Transitional Cell Carcinoma of the GU Tract — Unable to Evaluable | 4 |
| Ovarian Cancer — Complete Response - Score 1 | 1 |
| Ovarian Cancer — Very Good Response - Score 2 | 0 |
| Ovarian Cancer — Minor Response - Score 3 | 2 |
| Ovarian Cancer — Stable Disease - Score 4 | 11 |
| Ovarian Cancer — Progressive Disease - Score 5 | 16 |
| Ovarian Cancer — Unable to Evaluable | 7 |
| Gastric Cancer — Complete Response - Score 1 | 0 |
| Gastric Cancer — Very Good Response - Score 2 | 1 |
| Gastric Cancer — Minor Response - Score 3 | 5 |
| Gastric Cancer — Stable Disease - Score 4 | 1 |
| Gastric Cancer — Progressive Disease - Score 5 | 11 |
| Gastric Cancer — Unable to Evaluable | 9 |
| MSI high Colorectal Cancer — Complete Response - Score 1 | 1 |
| MSI high Colorectal Cancer — Very Good Response - Score 2 | 3 |
| MSI high Colorectal Cancer — Minor Response - Score 3 | 3 |
| MSI high Colorectal Cancer — Stable Disease - Score 4 | 3 |
| MSI high Colorectal Cancer — Progressive Disease - Score 5 | 5 |
| MSI high Colorectal Cancer — Unable to Evaluable | 1 |
| Percentage of Participants | Phase 2: Epacadostat 100 mg BID |
|---|---|
| Treatment-Emergent Adverse Events (TEAE) | 100 |
| Serious Treatment-Emergent Adverse Events | 51.0 |
Collected over Approximately 54 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: Epacadostat 25 mg BID | 2/4 (50%) | 0/4 (0%) | 4/4 (100%) |
| Phase 1: Epacadostat 50 MG BID | 13/20 (65%) | 8/20 (40%) | 18/20 (90%) |
| Phase 1: Epacadostat 100 MG BID | 12/18 (66.7%) | 9/18 (50%) | 17/18 (94.4%) |
| Phase 1: Epacadostat 300 MG BID | 14/20 (70%) | 9/20 (45%) | 20/20 (100%) |
| Phase 2: Epacadostat 100 MG BID | 209/382 (54.7%) | 195/382 (51%) | 375/382 (98.2%) |
| Total | 250/444 (56.3%) | 221/444 (49.8%) | 434/444 (97.7%) |
| Event | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 MG BID | Phase 1: Epacadostat 100 MG BID | Phase 1: Epacadostat 300 MG BID | Phase 2: Epacadostat 100 MG BID | Total |
|---|---|---|---|---|---|---|
| SepsisInfections and infestations | 0/4 | 0/20 | 0/18 | 2/20 | 8/382 | 10/444 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/4 | 1/20 | 1/18 | 0/20 | 33/382 | 35/444 |
| AnxietyPsychiatric disorders | 0/4 | 0/20 | 1/18 | 0/20 | 2/382 | 3/444 |
| Blood creatinine increasedInvestigations | 0/4 | 0/20 | 1/18 | 0/20 | 1/382 | 2/444 |
| Cardiac failureCardiac disorders | 0/4 | 0/20 | 1/18 | 0/20 | 0/382 | 1/444 |
| ColitisGastrointestinal disorders | 0/4 | 0/20 | 1/18 | 0/20 | 6/382 | 7/444 |
| Deep vein thrombosisVascular disorders | 0/4 | 0/20 | 1/18 | 0/20 | 3/382 | 4/444 |
| HaemorrhageVascular disorders | 0/4 | 0/20 | 1/18 | 0/20 | 0/382 | 1/444 |
| Meningitis asepticInfections and infestations | 0/4 | 0/20 | 1/18 | 0/20 | 2/382 | 3/444 |
| Mental status changesPsychiatric disorders | 0/4 | 0/20 | 1/18 | 0/20 | 1/382 | 2/444 |
| Event | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 MG BID | Phase 1: Epacadostat 100 MG BID | Phase 1: Epacadostat 300 MG BID | Phase 2: Epacadostat 100 MG BID | Total |
|---|---|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/4 | 9/20 | 4/18 | 6/20 | 64/382 | 87/444 |
| ConstipationGastrointestinal disorders | 3/4 | 8/20 | 4/18 | 3/20 | 86/382 | 104/444 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/4 | 7/20 | 3/18 | 9/20 | 100/382 | 122/444 |
| DiarrhoeaGastrointestinal disorders | 3/4 | 5/20 | 7/18 | 5/20 | 99/382 | 119/444 |
| FatigueGeneral disorders | 3/4 | 13/20 | 9/18 | 13/20 | 185/382 | 223/444 |
| NauseaGastrointestinal disorders | 3/4 | 9/20 | 5/18 | 11/20 | 115/382 | 143/444 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/4 | 3/20 | 0/18 | 5/20 | 40/382 | 51/444 |
| PruritusSkin and subcutaneous tissue disorders | 3/4 | 6/20 | 2/18 | 9/20 | 78/382 | 98/444 |
| DepressionPsychiatric disorders | 2/4 | 2/20 | 0/18 | 2/20 | 18/382 | 24/444 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/4 | 2/20 | 6/18 | 5/20 | 69/382 | 84/444 |
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
| Age, Continuous(years) | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 mg BID | Phase 1: Epacadostat 100 mg BID | Phase 1: Epacadostat 300 mg BID | Phase 2: Epacadostat 100 mg BID | Total |
|---|---|---|---|---|---|---|
| Mean | 48.8 ± 18.01 | 60.8 ± 12.97 | 63.2 ± 13.67 | 59.2 ± 13.06 | 62.7 ± 11.60 | 62.3 ± 11.92 |
| Sex: Female, Male(Participants) | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 mg BID | Phase 1: Epacadostat 100 mg BID | Phase 1: Epacadostat 300 mg BID | Phase 2: Epacadostat 100 mg BID | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 9 | 6 | 9 | 181 | 208 |
| Male | 1 | 11 | 12 | 11 | 201 | 236 |
| Race/Ethnicity, Customized(Participants) | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 mg BID | Phase 1: Epacadostat 100 mg BID | Phase 1: Epacadostat 300 mg BID | Phase 2: Epacadostat 100 mg BID | Total |
|---|---|---|---|---|---|---|
| White/Caucasian | 1 | 20 | 18 | 17 | 337 | 393 |
| Black/African-American | 1 | 0 | 0 | 2 | 19 | 22 |
| Asian | 1 | 0 | 0 | 1 | 15 | 17 |
| Native Hawaiian/Pacific Islander | 1 | 0 | 0 | 0 | 0 | 1 |
| Other | 0 | 0 | 0 | 0 | 9 | 9 |
| Missing | 0 | 0 | 0 | 0 | 2 | 2 |
| Race/Ethnicity, Customized(Participants) | Phase 1: Epacadostat 25 mg BID | Phase 1: Epacadostat 50 mg BID | Phase 1: Epacadostat 100 mg BID | Phase 1: Epacadostat 300 mg BID | Phase 2: Epacadostat 100 mg BID | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 | 16 | 18 |
| Not Hispanic or Latino | 4 | 20 | 17 | 19 | 353 | 413 |
| Unknown | 0 | 0 | 0 | 0 | 10 | 10 |
| Other | 0 | 0 | 0 | 0 | 2 | 2 |
| Missing | 0 | 0 | 0 | 0 | 1 | 1 |
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Studies of the drug tested here: Epacadostat