A Phase 2 interventional study of Navarixin and Pembrolizumab in Solid Tumors, Non-small Cell Lung Cancer and Castration Resistant Prostate Cancer, sponsored by Merck Sharp & Dohme LLC. Completed at 14 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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Among 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc — 14 open to participants now, 26 under way, 18 of them phase 3. Carcinoma, Non-Small-Cell Lung · Merck & Co., Inc.
Among the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc, this one is the 49th largest by enrollment of the 88 interventional ones that give a count, is one of 6 that started in 2018, is one of 24 in phase 2, and was the 44th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →14 of the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc are open now, in 12 countries. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 15 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Australia, Brazil and 17 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in Argentina, Australia, Brazil and 16 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 8 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 27 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 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.
91 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 23 · Phase 2 30 · Phase 3 40 · Phase 4 1
First in 2000; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 107 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 149 across the 88 interventional studies, 600 across the 3 observational. Of the 65 that completed or were terminated, 49 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
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.
3 of the studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05609968Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) | 2027-01-12 |
| NCT04380636Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | 2027-05-05 |
| NCT06074588Phase 3Merck Sharp & Dohme LLCSacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) | 2027-05-10 |
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Among the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the efficacy and safety of navarixin (MK-7123) in combination with pembrolizumab (MK-3475) in adults with one of three types of solid tumors: Programmed Death-Ligand 1 (PD-L1) positive refractory non-small cell lung cancer (NSCLC), castration resistant prostate cancer (CRPC) or microsatellite stable (MSS) colorectal cancer (CRC).
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.
All Participants
Non-small Cell Lung Cancer (NSCLC) Participants
Castration Resistant Prostate Cancer (CRPC) Participants
Microsatellite Stable Colorectal Cancer (MSS-CRC) Participants
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 received 30 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years
Drug: Navarixin · Biological: Pembrolizumab
Participants received 100 mg navarixin via oral capsules once daily, plus 200 mg pembrolizumab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Drug: Navarixin · Biological: Pembrolizumab
Oral capsules
Also known as: MK-7123, SCH 527123
Intravenous infusion
Also known as: MK-3475
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants 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) per RECIST 1.1. ORR was estimated using an exact method based on the binomial distribution, and the 95% confidence interval was estimated by the method of Clopper-Pearson.
Time frame: Up to approximately 2 years
Number of Participants With Dose-limiting Toxicities (DLTs) During Treatment Cycle 1
The following toxicities are considered a DLT, assessed as related to study treatment: Grade 4 non-hematologic toxicity, Grade 4 anemia, Grade 3 anemia lasting \>7 days or requiring transfusion, Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia, a) Grade 4 thrombocytopenia of any duration, b) Grade 3 thrombocytopenia associated with bleeding, Grade 3 non-hematologic toxicity lasting \>3 days, any Grade 3 or Grade 4 non-hematologic laboratory value if: medical intervention is required or the abnormality leads to hospitalization or persists for \>72 hours, Liver test abnormalities: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3X Upper Limit of Normal (ULN) with total bilirubin (TBL) \>2X ULN with no elevation in alkaline phosphatase (AP \<2X ULN), Grade 3 or Grade 4 febrile neutropenia, inability to administer ≥75% of the planned navarixin dose due to drug-related tolerability, delay in Cycle 2 start by \>2 weeks due to toxicity
Time frame: Up to 21 days
Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is 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 Discontinue Study Treatment Due to an AE
An AE is 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 2 years
Objective Response Rate (ORR) Per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST)
An objective response is defined as an immune-based Complete Response (iCR: Disappearance of all target lesions) or immune-based Partial Response (iPR: At least a 30% decrease in the sum of diameters of target lesions). ORR will be assessed by the investigator based on iRECIST following administration of navarixin in combination with pembrolizumab. The percentage of participants with progressive disease per RECIST 1.1 who experience an iCR or iPR are presented.
Time frame: Up to approximately 2 years
Progression-free Survival (PFS) Per RECIST 1.1
PFS is defined as the time from the first dose of study treatment to the first confirmed documented disease progression, or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered progression. Median PFS per RECIST 1.1 was assessed by the investigator from product-limit (Kaplan-Meier) method for censored data in participants with microsatellite stable colorectal cancer (CRC); with castration-resistant prostate cancer (CRPC), and with programmed cell death ligand 1 (PD-\[L\]1) refractory non-small cell lung cancer (NSCLC).
Time frame: Up to approximately 2 years
PFS Per iRECIST
PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Per iRECIST, progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. Disease progression is to be confirmed by a consecutive assessment at least 4-8 weeks after first documentation and will be assessed by the investigator. Median PFS per iRECIST was assessed by the investigator from product-limit (Kaplan-Meier) method for censored data in participants with microsatellite stable colorectal cancer (CRC); with castration-resistant prostate cancer (CRPC), and with programmed cell death ligand 1 (PD-\[L\]1) refractory non-small cell lung cancer (NSCLC).
Time frame: Up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death due to any cause. Median OS was assessed from product-limit (Kaplan-Meier) method for censored data in participants with microsatellite stable colorectal cancer (CRC); with castration-resistant prostate cancer (CRPC), and with programmed cell death ligand 1 (PD-\[L\]1) refractory non-small cell lung cancer (NSCLC).
Time frame: Up to approximately 2 years
Absolute Neutrophil Counts (ANC)
Peripheral blood neutrophil counts were performed at Cycle 1 Day 3: Predose, to determine the concentration of ANC.
Time frame: Day 3: Predose
Navarixin Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUC0-inf)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma AUC0-inf
Time frame: Cycle 1 Day 1: Predose & 1, 2, 4, 6 & 8-12 hours postdose; Cycle 1 Days 3 & 8: Predose & 6-12 hours postdose; Cycle 2 Day 1: Predose & 1, 2, 4, 6 & 8-12 hours postdose (Up to approximately 23 days)
Navarixin Area Under the Plasma Concentration-Time Curve From Time 0 to Last (AUC0-last)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma AUC0-last.
Time frame: Cycle 1 Day 1: Predose & 1, 2, 4, 6 & 8-12 hours postdose; Cycle 1 Days 3 & 8: Predose & 6-12 hours postdose; Cycle 2 Day 1: Predose & 1, 2, 4, 6 & 8-12 hours postdose(Up to approximately 23 days)
Navarixin Maximum Plasma Concentration (Cmax)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma Cmax.
Time frame: Cycle 1 Day 1: Predose & 1, 2, 4, 6 & 8-12 hours postdose; Cycle 1 Days 3 & 8: Predose & 6-12 hours postdose; Cycle 2 Day 1: Predose & 1, 2, 4, 6 & 8-12 hours postdose (Up to approximately 23 days)
Navarixin Trough Plasma Concentration (Ctrough)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected at steady state on Cycle 2 Day 21 to determine navarixin Ctrough. The Arithmetic Mean and CV% are presented.
Time frame: Cycle 2 Day 21 (Up to approximately 43 days)
Adults with one of the following types of solid tumors: Programmed Death-Ligand 1 (PD-L1) positive refractory non-small cell lung cancer (NSCLC), castration resistant prostate cancer (CRPC) or microsatellite stable (MSS) colorectal cancer (CRC), were enrolled in this study.
| Milestone | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Started | 52 | 55 |
| Treated | 51 | 54 |
| Completed | 0 | 0 |
| Not completed | 52 | 55 |
| Withdrew: Death | 48 | 44 |
| Withdrew: Sponsor decision | 2 | 7 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Not treated | 1 | 1 |
ORR is defined as the percentage of participants 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) per RECIST 1.1. ORR was estimated using an exact method based on the binomial distribution, and the 95% confidence interval was estimated by the method of Clopper-Pearson.
| Percentage of participants | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 3.9 (0.5 to 13.5) | 1.9 (0.0 to 9.9) |
The following toxicities are considered a DLT, assessed as related to study treatment: Grade 4 non-hematologic toxicity, Grade 4 anemia, Grade 3 anemia lasting \>7 days or requiring transfusion, Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia, a) Grade 4 thrombocytopenia of any duration, b) Grade 3 thrombocytopenia associated with bleeding, Grade 3 non-hematologic toxicity lasting \>3 days, any Grade 3 or Grade 4 non-hematologic laboratory value if: medical intervention is required or the abnormality leads to hospitalization or persists for \>72 hours, Liver test abnormalities: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3X Upper Limit of Normal (ULN) with total bilirubin (TBL) \>2X ULN with no elevation in alkaline phosphatase (AP \<2X ULN), Grade 3 or Grade 4 febrile neutropenia, inability to administer ≥75% of the planned navarixin dose due to drug-related tolerability, delay in Cycle 2 start by \>2 weeks due to toxicity
| Participants | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) During Treatment Cycle 1 | 2 | 3 |
An AE is 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 | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Event (AE) | 50 | 54 |
An AE is 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 | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Number of Participants Who Discontinue Study Treatment Due to an AE | 4 | 6 |
An objective response is defined as an immune-based Complete Response (iCR: Disappearance of all target lesions) or immune-based Partial Response (iPR: At least a 30% decrease in the sum of diameters of target lesions). ORR will be assessed by the investigator based on iRECIST following administration of navarixin in combination with pembrolizumab. The percentage of participants with progressive disease per RECIST 1.1 who experience an iCR or iPR are presented.
| Percentage of participants | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| iComplete Response (iCR) | 0.0 (0.0 to 8.2) | 0.0 (0.0 to 8.6) |
| iPartial Response (iPR) | 0.0 (0.0 to 8.2) | 0.0 (0.0 to 8.6) |
PFS is defined as the time from the first dose of study treatment to the first confirmed documented disease progression, or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered progression. Median PFS per RECIST 1.1 was assessed by the investigator from product-limit (Kaplan-Meier) method for censored data in participants with microsatellite stable colorectal cancer (CRC); with castration-resistant prostate cancer (CRPC), and with programmed cell death ligand 1 (PD-\[L\]1) refractory non-small cell lung cancer (NSCLC).
| Months | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| CRC | 1.8 (1.0 to 2.0) | 1.9 (1.6 to 2.0) |
| CRPC | 2.1 (1.9 to 4.1) | 2.1 (1.9 to 4.5) |
| NSCLC | 2.4 (1.6 to 10.2) | 2.1 (1.9 to 2.4) |
PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Per iRECIST, progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. Disease progression is to be confirmed by a consecutive assessment at least 4-8 weeks after first documentation and will be assessed by the investigator. Median PFS per iRECIST was assessed by the investigator from product-limit (Kaplan-Meier) method for censored data in participants with microsatellite stable colorectal cancer (CRC); with castration-resistant prostate cancer (CRPC), and with programmed cell death ligand 1 (PD-\[L\]1) refractory non-small cell lung cancer (NSCLC).
| Months | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| CRC | 4.1 (2.1 to 7.1) | 6.2 (3.3 to 14.4) |
| CRPC | 7.9 (5.0 to 8.6) | 5.2 (3.0 to 11.5) |
| NSCLC | 11.9 (3.2 to 17.5) | 7.0 (2.4 to 14.4) |
OS is defined as the time from the first dose of study treatment to death due to any cause. Median OS was assessed from product-limit (Kaplan-Meier) method for censored data in participants with microsatellite stable colorectal cancer (CRC); with castration-resistant prostate cancer (CRPC), and with programmed cell death ligand 1 (PD-\[L\]1) refractory non-small cell lung cancer (NSCLC).
| Months | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| CRC | 6.5 (3.0 to 9.7) | 8.0 (5.7 to 14.4) |
| CRPC | 10.8 (7.9 to 13.4) | 11.2 (3.7 to 23.0) |
| MSCLC | 13.0 (3.2 to 18.0) | 12.0 (2.4 to 19.9) |
Peripheral blood neutrophil counts were performed at Cycle 1 Day 3: Predose, to determine the concentration of ANC.
| 10^9 cells/L | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Absolute Neutrophil Counts (ANC) | 3.6 (3.03 to 4.12) | 3.2 (2.50 to 3.84) |
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma AUC0-inf
| h*ng/mL | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Navarixin Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUC0-inf) | 523 ± 39.5 | 1200 ± 47.5 |
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma AUC0-last.
| h*ng/mL | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Navarixin Area Under the Plasma Concentration-Time Curve From Time 0 to Last (AUC0-last) | 451 ± 35.7 | 961 ± 45.9 |
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma Cmax.
| ng/mL | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Navarixin Maximum Plasma Concentration (Cmax) | 172 ± 53.3 | 288 ± 60.6 |
Plasma samples from participants with selected advanced/metastatic solid tumors were collected at steady state on Cycle 2 Day 21 to determine navarixin Ctrough. The Arithmetic Mean and CV% are presented.
| ng/mL | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| Navarixin Trough Plasma Concentration (Ctrough) | NA ± NA | NA ± NA |
Collected over All-cause mortality: From randomization up to approximately 27 months; Adverse Events (AEs) from first treatment up to approximately 27 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Navarixin 30 mg + Pembrolizumab 200 mg | 48/52 (92.3%) | 17/51 (33.3%) | 48/51 (94.1%) |
| Navarixin 100 mg + Pembrolizumab 200 mg | 45/55 (81.8%) | 15/54 (27.8%) | 52/54 (96.3%) |
| Event | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| PneumoniaInfections and infestations | 4/51 | 1/54 |
| ColitisGastrointestinal disorders | 1/51 | 0/54 |
| Small intestinal obstructionGastrointestinal disorders | 1/51 | 1/54 |
| VomitingGastrointestinal disorders | 1/51 | 1/54 |
| PyrexiaGeneral disorders | 1/51 | 1/54 |
| Lower respiratory tract infectionInfections and infestations | 1/51 | 0/54 |
| Urinary tract infectionInfections and infestations | 1/51 | 1/54 |
| Spinal compression fractureInjury, poisoning and procedural complications | 1/51 | 0/54 |
| Aspartate aminotransferase increasedInvestigations | 1/51 | 0/54 |
| Neutrophil count decreasedInvestigations | 1/51 | 0/54 |
| Event | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg |
|---|---|---|
| FatigueGeneral disorders | 17/51 | 14/54 |
| NauseaGastrointestinal disorders | 9/51 | 16/54 |
| Decreased appetiteMetabolism and nutrition disorders | 14/51 | 8/54 |
| PyrexiaGeneral disorders | 12/51 | 12/54 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/51 | 8/54 |
| VomitingGastrointestinal disorders | 5/51 | 10/54 |
| Neutrophil count decreasedInvestigations | 7/51 | 10/54 |
| Back painMusculoskeletal and connective tissue disorders | 6/51 | 10/54 |
| Abdominal painGastrointestinal disorders | 9/51 | 5/54 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/51 | 5/54 |
| Age, Continuous(Years) | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg | Total |
|---|---|---|---|
| Mean | 64.1 ± 13.3 | 62.8 ± 13.0 | 63.4 ± 13.1 |
| Sex: Female, Male(Participants) | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 37 | 41 | 78 |
| Ethnicity (NIH/OMB)(Participants) | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 49 | 54 | 103 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Navarixin 30 mg + Pembrolizumab 200 mg | Navarixin 100 mg + Pembrolizumab 200 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 14 | 11 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 36 | 39 | 75 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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 Apr 2018 to primary completion in May 2021, 37 months.
Results were first posted in Jun 2022, 1 year 1 month after primary completion.
Of 317 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's 37 months is close to that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Navarixin
Carcinoma, Non-Small-Cell Lung →