Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034)
CompletedPhase 2Results postedLast updated 28 August 2024
What this trial tests
Phase 2 trial testing Navarixin in Solid Tumors in 107 participants. Completed in 19 May 2021.
18 and older, any sex, with Solid Tumors or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)Primary· Up to approximately 2 years
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.
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
3.9
0.5 – 13.5
Navarixin 100 mg + Pembrolizumab 200 mg
1.9
0.0 – 9.9
Number of Participants With Dose-limiting Toxicities (DLTs) During Treatment Cycle 1Primary· Up to 21 days
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 abnormal
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
2
Navarixin 100 mg + Pembrolizumab 200 mg
3
Number of Participants Who Experience at Least One Adverse Event (AE)Primary· Up to approximately 27 months
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.
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
50
Navarixin 100 mg + Pembrolizumab 200 mg
54
Number of Participants Who Discontinue Study Treatment Due to an AEPrimary· Up to approximately 2 years
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.
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
4
Navarixin 100 mg + Pembrolizumab 200 mg
6
Objective Response Rate (ORR) Per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST)Secondary· Up to approximately 2 years
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.
iComplete Response (iCR)
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
0.0
0.0 – 8.2
Navarixin 100 mg + Pembrolizumab 200 mg
0.0
0.0 – 8.6
iPartial Response (iPR)
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
0.0
0.0 – 8.2
Navarixin 100 mg + Pembrolizumab 200 mg
0.0
0.0 – 8.6
Progression-free Survival (PFS) Per RECIST 1.1Secondary· Up to approximately 2 years
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 w
CRC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
1.8
1.0 – 2.0
Navarixin 100 mg + Pembrolizumab 200 mg
1.9
1.6 – 2.0
CRPC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
2.1
1.9 – 4.1
Navarixin 100 mg + Pembrolizumab 200 mg
2.1
1.9 – 4.5
NSCLC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
2.4
1.6 – 10.2
Navarixin 100 mg + Pembrolizumab 200 mg
2.1
1.9 – 2.4
PFS Per iRECISTSecondary· Up to approximately 2 years
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
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
4.1
2.1 – 7.1
Navarixin 100 mg + Pembrolizumab 200 mg
6.2
3.3 – 14.4
CRPC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
7.9
5.0 – 8.6
Navarixin 100 mg + Pembrolizumab 200 mg
5.2
3.0 – 11.5
NSCLC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
11.9
3.2 – 17.5
Navarixin 100 mg + Pembrolizumab 200 mg
7.0
2.4 – 14.4
Overall Survival (OS)Secondary· Up to approximately 2 years
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).
CRC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
6.5
3.0 – 9.7
Navarixin 100 mg + Pembrolizumab 200 mg
8.0
5.7 – 14.4
CRPC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
10.8
7.9 – 13.4
Navarixin 100 mg + Pembrolizumab 200 mg
11.2
3.7 – 23.0
MSCLC
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
13.0
3.2 – 18.0
Navarixin 100 mg + Pembrolizumab 200 mg
12.0
2.4 – 19.9
Absolute Neutrophil Counts (ANC)Secondary· Day 3: Predose
Peripheral blood neutrophil counts were performed at Cycle 1 Day 3: Predose, to determine the concentration of ANC.
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
3.6
3.03 – 4.12
Navarixin 100 mg + Pembrolizumab 200 mg
3.2
2.50 – 3.84
Navarixin Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUC0-inf)Secondary· 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)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma AUC0-inf
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
523
± 39.5
Navarixin 100 mg + Pembrolizumab 200 mg
1200
± 47.5
Navarixin Area Under the Plasma Concentration-Time Curve From Time 0 to Last (AUC0-last)Secondary· 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)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma AUC0-last.
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
451
± 35.7
Navarixin 100 mg + Pembrolizumab 200 mg
961
± 45.9
Navarixin Maximum Plasma Concentration (Cmax)Secondary· 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)
Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma Cmax.
Group
Value
95% CI
Navarixin 30 mg + Pembrolizumab 200 mg
172
± 53.3
Navarixin 100 mg + Pembrolizumab 200 mg
288
± 60.6
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: From randomization up to approximately 27 months; Adverse Events (AEs) from first treatment up to approximately 27 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Navarixin 30 mg + Pembrolizumab 200 mg
Serious: 17/51 (33%)
Deaths: 48/52
Navarixin 100 mg + Pembrolizumab 200 mg
Serious: 15/54 (28%)
Deaths: 45/55
Serious adverse events (29 terms)
Reaction
System
Navarixin 30 mg + Pembroli…
Navarixin 100 mg + Pembrol…
Pneumonia
Infections and infestations
—
—
Colitis
Gastrointestinal disorders
—
—
Intestinal fistula
Gastrointestinal disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
General physical health deterioration
General disorders
—
—
Pyrexia
General disorders
—
—
Hepatitis
Hepatobiliary disorders
—
—
Lower respiratory tract infection
Infections and infestations
—
—
Pseudomonas infection
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Humerus fracture
Injury, poisoning and procedural complications
—
—
Spinal compression fracture
Injury, poisoning and procedural complications
—
—
Aspartate aminotransferase increased
Investigations
—
—
Neutrophil count decreased
Investigations
—
—
Transaminases increased
Investigations
—
—
Cachexia
Metabolism and nutrition disorders
—
—
Hypophosphataemia
Metabolism and nutrition disorders
—
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01006616 — Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-
· Phase 2
· terminated
NCT00688467 — Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)
· Phase 2
· completed
NCT00632502 — Neutrophilic Asthma Study With Navarixin (MK-7123, SCH 527123) (MK-7123-017)(COMPLETED)
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 28 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03473925.