A Phase 1 interventional study of MK-7162 and Pembrolizumab in Solid Neoplasms, sponsored by Merck Sharp & Dohme LLC. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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The purposes of this study are to determine the safety and tolerability of MK-7162 when administered in combination with pembrolizumab (MK-3475) and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-7162 when administered in combination with pembrolizumab.
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) 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.
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.
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 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.
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.
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.
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.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
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.
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.
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.
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.
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.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive MK-7162 25 mg via oral tablets once daily (QD) throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (every 3 weeks \[Q3W\]).
Drug: MK-7162 · Biological: Pembrolizumab
Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
Drug: MK-7162 · Biological: Pembrolizumab
Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
Drug: MK-7162 · Biological: Pembrolizumab
Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
Drug: MK-7162 · Biological: Pembrolizumab
oral tablets
IV infusion
Also known as: MK-3475, Keytruda
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 by the Investigator
The following events, if considered drug related by the investigator, are considered a DLT: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with bleeding; Nonhematologic Adverse Events (AE) ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment during Cycles 1 or 2; Prolonged delay (\>2 weeks) in initiating Cycles 2 or 3 due to treatment-related toxicity; Missing \>25% of MK-7162 doses as a result of treatment-related AE during Cycles 1 or 2; Grade 5 toxicity.
Time frame: Cycle 1 and Cycle 2 (Up to 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Time frame: Up to Approximately 27 Months
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to Approximately 26 Months
Area Under the Concentration-Time Curve (AUC) From 0-8 Hours of MK-7261 Alone and in Combination With Pembrolizumab
Blood samples were collected at designated time points for determining the AUC₀-₈ of MK-7162 in plasma when administered alone and in combination with pembrolizumab.
Time frame: Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Days 1 & 15; and Cycle 3, Day 1
Minimum Plasma Concentration (Cmin) of MK-7162
Blood samples were obtained at designated time points to determine the Cmin of MK-7162 in plasma.
Time frame: Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Day 14
Maximum Plasma Concentration (Cmax) of MK-7162 When Administered Alone and in Combination With Pembrolizumab
Blood samples were collected at designated time points to determine the Cmax of MK-7162 in plasma when administered alone and in combination with pembrolizumab.
Time frame: Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Days 1 and 15 and Cycle 3, Day 1
Kynurenine (KYN) Biomarker Plasma Concentration
MK-7162 is a selective inhibitor of Indoleamine-2,3-dioxygenase-1 (IDO1) activity which, in turn, reduces the conversion of TRP to KYN. Venous blood samples were collected after an overnight fast for measurement of plasma levels of KYN as a pharmacodynamic biomarker of IDO1 inhibition.
Time frame: Cycle 1 Days 1 & 15: predose, 1, 2, 4 & 8 hours postdose; Cycle 2 Day 1: predose; Cycle 3 Day 1: predose, 1, 2, 4 & 8 hours postdose; Cycle 3 Day 15: predose
Tryptophan (TRP) Biomarker Plasma Concentration
MK-7162 is a selective inhibitor of Indoleamine-2,3-dioxygenase-1 (IDO1) activity which, in turn, reduces the conversion of TRP to KYN. Venous blood samples were collected at designated time points after an overnight fast for measurement of plasma levels of TRP as a pharmacodynamic biomarker of IDO1 inhibition.
Time frame: Cycle 1 Days 1 & 15: predose, 1, 2, 4 & 8 hours postdose; Cycle 2 Day 1: predose; Cycle 3 Day 1: predose, 1, 2, 4 & 8 hours postdose; Cycle 3 Day 15: predose
Objective Response Rate (ORR) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by the Investigator. The percentage of participants who experience a CR or PR based on RECIST 1.1 will be presented.
Time frame: Up to approximately 28 months
Overall Response Based on Immune Response Evaluation Criteria (iRECIST) In Solid Tumors
Participants with PD by RECIST 1.1 as determined by investigator underwent confirmatory imaging to classify the disease as confirmed progressive disease (iCPD), unconfirmed progressive disease \[iUPD\]), stable disease (iSD), partial response (iPR) or complete response (iCR). iCPD definition: Worsening of target lesions (increase in the sum of diameters of ≥5 mm); Any significant growth in non-target lesions, Appearance of new lesions, increase in new lesion sum of diameters by ≥5 mm; Visible growth of new non-target lesions; or appearance of new factor that would have triggered PD by RECIST 1.1. Responses are classified as iSD or iPR (depending on the sum of diameters of the target lesions), or iCR if all lesions resolve. iUPD overall response is defined as none of the progression-confirming factors identified in iCPD occurs AND The target lesion sum of diameters (initial target lesions) remains above the initial PD threshold (by RECIST 1.1)
Time frame: Up to approximately 28 months
This study included a screening period to determine eligibility. 41 participants were screened for this study and 33 were randomized.
| Milestone | MK-7162 25 mg + Pembrolizumab (Pembro) | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 15 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 6 | 6 | 6 | 15 |
| Withdrew: Death | 6 | 4 | 5 | 14 |
| Withdrew: In survival phase status at study closure. participant transferred to pembrolizumab extension study | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 1 |
The following events, if considered drug related by the investigator, are considered a DLT: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with bleeding; Nonhematologic Adverse Events (AE) ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment during Cycles 1 or 2; Prolonged delay (\>2 weeks) in initiating Cycles 2 or 3 due to treatment-related toxicity; Missing \>25% of MK-7162 doses as a result of treatment-related AE during Cycles 1 or 2; Grade 5 toxicity.
| Participants | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 by the Investigator | 0 | 0 | 0 | 5 |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
| Participants | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 6 | 6 | 6 | 15 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
| Participants | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Number of Participants Who Discontinued Study Drug Due to an AE | 0 | 0 | 1 | 4 |
Blood samples were collected at designated time points for determining the AUC₀-₈ of MK-7162 in plasma when administered alone and in combination with pembrolizumab.
| hr*nM | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Day 1, Cycle 1: MK-7162 alone | 4400 ± 36.5 | 8640 ± 29.9 | 20700 ± 32.6 | 31700 ± 44.4 |
| Day 15, Cycle 1: MK-7162 alone | 10300 ± 37.3 | 19200 ± 90.7 | 47300 ± 87.8 | 118000 ± 93.5 |
| Day 1, Cycle 3: MK-7162 + Pembrolizumab | 12200 ± 27.7 | 20900 ± 101.2 | 36100 ± 117.8 | 10700 ± 98.4 |
Blood samples were obtained at designated time points to determine the Cmin of MK-7162 in plasma.
| nM | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Minimum Plasma Concentration (Cmin) of MK-7162 | 1070 ± 73.1 | 1260 ± 219.9 | 3390 ± 130.3 | 13800 ± 177.3 |
Blood samples were collected at designated time points to determine the Cmax of MK-7162 in plasma when administered alone and in combination with pembrolizumab.
| nM | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Day 1 Cycle 1: MK-7162 alone | 902 ± 48.0 | 1750 ± 27.8 | 4420 ± 28.2 | 6550 ± 48.6 |
| Day15 Cycle 1: MK-7162 Alone | 1940 ± 38.3 | 3560 ± 64.1 | 8910 ± 84.5 | 20600 ± 77.0 |
| Day 1 Cycle 3: MK-7162+ Pembrolizumab | 2140 ± 52.2 | 3120 ± 96.2 | 6110 ± 100.9 | 17800 ± 77.9 |
MK-7162 is a selective inhibitor of Indoleamine-2,3-dioxygenase-1 (IDO1) activity which, in turn, reduces the conversion of TRP to KYN. Venous blood samples were collected after an overnight fast for measurement of plasma levels of KYN as a pharmacodynamic biomarker of IDO1 inhibition.
| μmol/L | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Cycle 1 Day 1, Predose | 1.9 (1.2 to 2.7) | 1.5 (1.2 to 2.2) | 2.3 (1.4 to 3.4) | 1.7 (0.5 to 2.5) |
| Cycle 1 Day 1, 1 Hour (hr) Postdose | 1.9 (1.1 to 2.5) | 1.5 (1.1 to 1.8) | 2.2 (1.4 to 3.2) | 1.5 (0.5 to 2.2) |
| Cycle 1 Day 1, 2 Hr Postdose | 2.0 (1.2 to 2.7) | 1.5 (1.1 to 2.1) | 2.2 (1.4 to 3.2) | 1.5 (0.6 to 2.5) |
| Cycle 1 Day 1, 4 Hr Postdose | 2.0 (1.5 to 2.6) | 1.5 (1.2 to 1.9) | 2.1 (1.3 to 3.0) | 1.5 (0.6 to 2.4) |
| Cycle 1 Day1, 8 Hr Postdose | 1.8 (1.1 to 2.6) | 1.4 (0.9 to 1.9) | 2.0 (1.1 to 2.7) | 1.4 (0.6 to 2.6) |
| Cycle 1 Day 15, Predose | 1.6 (1.0 to 2.3) | 1.2 (0.8 to 1.5) | 1.3 (0.4 to 2.3) | 1.0 (0.6 to 2.2) |
| Cycle 1 Day 15, 1 Hr Postdose | 1.7 (1.0 to 2.6) | 1.2 (0.9 to 1.4) | 1.3 (0.3 to 2.3) | 1.0 (0.6 to 2.3) |
| Cycle 1 Day 15, 2 Hr Postdose | 1.8 (1.3 to 2.6) | 1.2 (0.8 to 1.5) | 1.3 (0.4 to 2.2) | 1.0 (0.6 to 2.1) |
| Cycle 1 Day 15, 4 Hr Postdose | 1.8 (1.3 to 2.8) | 1.2 (1.0 to 1.6) | 1.3 (0.4 to 2.1) | 1.1 (0.6 to 2.4) |
| Cycle 1 Day 15, 8 Hr Postdose | 1.7 (1.0 to 2.3) | 1.1 (0.9 to 1.4) | 1.2 (0.2 to 2.1) | 1.0 (0.6 to 2.2) |
| Cycle 2 Day 1, Predose | 2.1 (1.2 to 2.1) | 1.2 (1.2 to 1.2) | 0.6 (0.6 to 0.7) | 1.0 (0.6 to 1.7) |
| Cycle 3 Day 1, Predose | 1.8 (1.1 to 2.5) | 1.6 (1.1 to 1.9) | 1.4 (0.4 to 2.3) | 1.1 (0.4 to 2.3) |
| Cycle 3 Day 1, 1 Hr Postdose | 1.8 (1.0 to 2.4) | 1.6 (1.3 to 2.0) | 1.3 (0.4 to 2.3) | 1.1 (0.4 to 2.2) |
| Cycle 3 Day 1, 2 Hr Postdose | 2.0 (1.0 to 2.8) | 1.6 (1.2 to 1.8) | 1.4 (0.1 to 2.3) | 1.1 (0.4 to 2.4) |
| Cycle 3 Day 1, 4 Hr Postdose | 2.0 (1.2 to 2.9) | 1.6 (1.3 to 1.9) | 1.4 (0.4 to 2.5) | 1.1 (0.3 to 2.3) |
| Cycle 3 Day 1, 8 Hr Postdose | 1.8 (1.0 to 2.6) | 1.6 (1.2 to 1.9) | 1.4 (0.5 to 2.4) | 1.1 (0.2 to 2.3) |
| Cycle 3 Day 15, PreDose | 2.0 (0.9 to 3.0) | 2.2 (1.3 to 4.1) | 1.5 (1.4 to 1.6) | 0.9 (0.5 to 1.9) |
MK-7162 is a selective inhibitor of Indoleamine-2,3-dioxygenase-1 (IDO1) activity which, in turn, reduces the conversion of TRP to KYN. Venous blood samples were collected at designated time points after an overnight fast for measurement of plasma levels of TRP as a pharmacodynamic biomarker of IDO1 inhibition.
| mg/dL | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Cycle 1 Day1, Predose | 0.7 (0.5 to 1.0) | 0.8 (0.5 to 1.1) | 0.7 (0.3 to 1.1) | 0.7 (0.3 to 1.4) |
| Cycle 1 Day 1, 1 Hr Postdose | 0.7 (0.5 to 0.9) | 0.8 (0.5 to 1.2) | 0.6 (0.3 to 0.8) | 0.6 (0.3 to 1.4) |
| Cycle 1 Day 1, 2 Hr Postdose | 0.8 (0.5 to 1.1) | 0.9 (0.4 to 1.3) | 0.7 (0.4 to 0.9) | 0.7 (0.2 to 1.6) |
| Cycle 1 Day 1, 4 Hr Postdose | 0.9 (0.6 to 1.1) | 0.9 (0.4 to 1.2) | 0.7 (0.4 to 1.0) | 0.8 (0.5 to 1.7) |
| Cycle 1 Day 1, 8 Hr Postdose | 0.9 (0.6 to 1.2) | 0.9 (0.4 to 1.7) | 0.8 (0.4 to 1.0) | 0.8 (0.4 to 1.4) |
| Cycle 1 Day 15, Predose | 0.8 (0.6 to 0.9) | 0.8 (0.6 to 0.9) | 0.6 (0.2 to 1.2) | 0.7 (0.3 to 1.6) |
| Cycle 1 Day 15, 1 Hr Postdose | 0.9 (0.6 to 1.0) | 0.7 (0.5 to 0.9) | 0.6 (0.2 to 1.0) | 0.7 (0.3 to 1.4) |
| Cycle 1 Day 15, 2 Hr Postdose | 0.9 (0.8 to 1.0) | 0.8 (0.5 to 1.1) | 0.6 (0.3 to 1.0) | 0.6 (0.3 to 1.2) |
| Cycle 1 Day 15, 4 Hr Postdose | 1.0 (0.6 to 1.1) | 0.8 (0.5 to 1.0) | 0.7 (0.4 to 1.1) | 0.7 (0.4 to 1.6) |
| Cycle 1 Day 15,8 Hr Postdose | 1.0 (0.8 to 1.1) | 0.8 (0.5 to 1.0) | 0.7 (0.2 to 1.2) | 0.7 (0.3 to 1.7) |
| Cycle 2 Day 1, Predose | 0.8 (0.8 to 0.9) | 0.6 (0.6 to 0.6) | 0.7 (0.3 to 1.0) | 0.6 (0.4 to 1.0) |
| Cycle 3 Day 1, Predose | 0.8 (0.5 to 0.9) | 0.7 (0.6 to 0.8) | 0.5 (0.2 to 0.8) | 0.7 (0.2 to 1.2) |
| Cycle 3 Day 1, 1 Hr Postdose | 0.8 (0.7 to 0.8) | 0.7 (0.5 to 0.9) | 0.5 (0.2 to 0.7) | 0.7 (0.3 to 1.4) |
| Cycle 3 Day 1, 2 Hr Postdose | 0.9 (0.8 to 1.1) | 0.8 (0.7 to 1.0) | 0.6 (0.2 to 0.9) | 0.7 (0.4 to 1.4) |
| Cycle 3 Day 1, 4 Hr Postdose | 0.9 (0.8 to 1.0) | 0.8 (0.6 to 0.9) | 0.6 (0.2 to 0.8) | 0.8 (0.4 to 1.4) |
| Cyle 3 Day 1, 8 Hr Postdose | 0.9 (0.4 to 1.2) | 0.7 (0.5 to 0.8) | 0.6 (0.3 to 0.9) | 0.8 (0.4 to 1.4) |
| Cycle 3 Day 15, Predose | 0.8 (0.5 to 1.0) | 0.6 (0.3 to 0.7) | 0.6 (0.4 to 0.8) | 0.6 (0.3 to 1.2) |
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by the Investigator. The percentage of participants who experience a CR or PR based on RECIST 1.1 will be presented.
| Percentage of Participants | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| Objective Response Rate (ORR) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | 0.0 (0.0 to 45.9) | 16.7 (0.4 to 64.1) | 0.0 (0.0 to 45.9) | 0.0 (0.0 to 21.8) |
Participants with PD by RECIST 1.1 as determined by investigator underwent confirmatory imaging to classify the disease as confirmed progressive disease (iCPD), unconfirmed progressive disease \[iUPD\]), stable disease (iSD), partial response (iPR) or complete response (iCR). iCPD definition: Worsening of target lesions (increase in the sum of diameters of ≥5 mm); Any significant growth in non-target lesions, Appearance of new lesions, increase in new lesion sum of diameters by ≥5 mm; Visible growth of new non-target lesions; or appearance of new factor that would have triggered PD by RECIST 1.1. Responses are classified as iSD or iPR (depending on the sum of diameters of the target lesions), or iCR if all lesions resolve. iUPD overall response is defined as none of the progression-confirming factors identified in iCPD occurs AND The target lesion sum of diameters (initial target lesions) remains above the initial PD threshold (by RECIST 1.1)
| Percentage of Participants | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro |
|---|---|---|---|---|
| iCR | 0.0 (0.0 to 52.2) | 0.0 (0.0 to 52.2) | 0.0 (0.0 to 70.8) | 0.0 (0.0 to 26.5) |
| iPR | 0.0 (0.0 to 52.2) | 0.0 (0.0 to 52.2) | 0.0 (0.0 to 70.8) | 0.0 (0.0 to 26.5) |
| iSD | 0.0 (0.0 to 52.2) | 0.0 (0.0 to 52.2) | 0.0 (0.0 to 70.8) | 0.0 (0.0 to 26.5) |
| iUPD | 80.0 (28.4 to 99.5) | 60.0 (14.7 to 94.7) | 100.0 (29.2 to 100.0) | 75.0 (42.8 to 94.5) |
| iCPD | 20.0 (0.5 to 71.6) | 40.0 (5.3 to 85.3) | 0.0 (0.0 to 70.8) | 25.0 (5.5 to 57.2) |
Collected over Up to approximately 27 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-7162 25mg + Pembro | 6/6 (100%) | 1/6 (16.7%) | 6/6 (100%) |
| MK-7162 50mg + Pembro | 4/6 (66.7%) | 3/6 (50%) | 6/6 (100%) |
| MK-7162 100mg + Pembro | 5/6 (83.3%) | 3/6 (50%) | 6/6 (100%) |
| MK-7162 200mg + Pembro | 14/15 (93.3%) | 5/15 (33.3%) | 15/15 (100%) |
| Event | MK-7162 25mg + Pembro | MK-7162 50mg + Pembro | MK-7162 100mg + Pembro | MK-7162 200mg + Pembro |
|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/6 | 0/6 | 1/6 | 0/15 |
| Intestinal obstructionGastrointestinal disorders | 0/6 | 0/6 | 1/6 | 0/15 |
| Small intestinal obstructionGastrointestinal disorders | 0/6 | 1/6 | 0/6 | 0/15 |
| GastroenteritisInfections and infestations | 0/6 | 1/6 | 0/6 | 0/15 |
| Back painMusculoskeletal and connective tissue disorders | 0/6 | 1/6 | 0/6 | 0/15 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/6 | 1/6 | 0/6 | 0/15 |
| Tumour ulcerationNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/6 | 0/6 | 1/6 | 0/15 |
| Female genital tract fistulaReproductive system and breast disorders | 0/6 | 1/6 | 0/6 | 0/15 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/6 | 0/6 | 0/6 | 0/15 |
| EmbolismVascular disorders | 0/6 | 1/6 | 0/6 | 0/15 |
| Event | MK-7162 25mg + Pembro | MK-7162 50mg + Pembro | MK-7162 100mg + Pembro | MK-7162 200mg + Pembro |
|---|---|---|---|---|
| FatigueGeneral disorders | 1/6 | 3/6 | 3/6 | 9/15 |
| AnaemiaBlood and lymphatic system disorders | 2/6 | 3/6 | 0/6 | 2/15 |
| ConstipationGastrointestinal disorders | 1/6 | 3/6 | 3/6 | 1/15 |
| Weight decreasedInvestigations | 0/6 | 3/6 | 0/6 | 0/15 |
| PruritusSkin and subcutaneous tissue disorders | 1/6 | 3/6 | 1/6 | 1/15 |
| DiarrhoeaGastrointestinal disorders | 0/6 | 2/6 | 0/6 | 3/15 |
| NauseaGastrointestinal disorders | 0/6 | 2/6 | 2/6 | 3/15 |
| VomitingGastrointestinal disorders | 0/6 | 2/6 | 2/6 | 3/15 |
| PyrexiaGeneral disorders | 1/6 | 1/6 | 2/6 | 4/15 |
| CholangitisHepatobiliary disorders | 2/6 | 0/6 | 0/6 | 0/15 |
| Age, Continuous(Years) | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro | Total |
|---|---|---|---|---|---|
| Mean | 60.0 ± 14.5 | 56.0 ± 14.2 | 61.7 ± 9.9 | 59.6 ± 12.8 | 59.4 ± 12.4 |
| Sex: Female, Male(Participants) | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro | Total |
|---|---|---|---|---|---|
| Female | 4 | 4 | 4 | 8 | 20 |
| Male | 2 | 2 | 2 | 7 | 13 |
| Ethnicity (NIH/OMB)(Participants) | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 2 | 2 |
| Not Hispanic or Latino | 5 | 6 | 6 | 12 | 29 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | MK-7162 25 mg + Pembro | MK-7162 50 mg + Pembro | MK-7162 100 mg + Pembro | MK-7162 200 mg + Pembro | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 3 | 5 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 2 | 3 |
| White | 5 | 5 | 3 | 7 | 20 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Dec 2017 to primary completion in Oct 2020, 34 months.
Results were first posted in Nov 2021, 1 year after primary completion.
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