Phase 2
Completed N=107
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)
Solid Tumors · Non-Small Cell Lung Cancer · Metastatic Castration Resistant Prostate Cancer · Microsatellite-stable colorectal cancer
Source: ClinicalTrials.gov NCT03473925 ↗
Enrolled (actual)
107
Serious AEs
30.5%
Results posted
Jun 2022
Primary outcomePrimary: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) — 3.9; 1.9 Percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
3.9; 1.9 | — |
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLTs) During Treatment Cycle 1 |
2; 3 | — |
| PRIMARY Number of Participants Who Experience at Least One Adverse Event (AE) |
50; 54 | — |
| PRIMARY Number of Participants Who Discontinue Study Treatment Due to an AE |
4; 6 | — |
| SECONDARY Objective Response Rate (ORR) Per Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST) |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Progression-free Survival (PFS) Per RECIST 1.1 |
1.8; 1.9; 2.1; 2.1; 2.4; 2.1 | — |
| SECONDARY PFS Per iRECIST |
4.1; 6.2; 7.9; 5.2; 11.9; 7.0 | — |
| SECONDARY Overall Survival (OS) |
6.5; 8.0; 10.8; 11.2; 13.0; 12.0 | — |
| SECONDARY Absolute Neutrophil Counts (ANC) |
3.6; 3.2 | — |
| SECONDARY Navarixin Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUC0-inf) |
523; 1200 | — |
| SECONDARY Navarixin Area Under the Plasma Concentration-Time Curve From Time 0 to Last (AUC0-last) |
451; 961 | — |
| SECONDARY Navarixin Maximum Plasma Concentration (Cmax) |
172; 288 | — |
| SECONDARY Navarixin Trough Plasma Concentration (Ctrough) |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
All Participants
- Has one of the following histologically- or cytologically-confirmed advanced/metastatic solid tumors: NSCLC, CRPC, or MSS CRC, by pathology report and has received, or been intolerant to, or has been ineligible for all treatment known to confer clinical benefit.
- Has Stage III or Stage IV disease that is not surgically resectable.
- Has measurable disease by RECIST 1.1 criteria as assessed by the local site investigator/radiology.
- Has supplied tumor tissue from either a newly obtained biopsy or an archival specimen for biomarker analysis.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- Female participants must agree to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- Demonstrates adequate organ function.
Non-small Cell Lung Cancer (NSCLC) Participants
- Has histologically or cytologically confirmed diagnosis of Stage IV metastatic NSCLC.
- Has progressed on treatment with an anti-Programmed Death-Ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-L1 treatment progression is defined by meeting all of the following criteria: a) Has received ≥2 doses of an approved anti-PD-L1 mAb; b) Has demonstrated disease progression after anti-PD-L1 as defined by RECIST 1.1; c) Progressive disease has been documented within 12 weeks from the last dose of anti-PD-L1 mAb.
Castration Resistant Prostate Cancer (CRPC) Participants
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate. Components of small cell prostate cancer are permitted.
- Has prostate cancer progression on the most recent treatment, as determined by the investigator, by means of one of the following: a) Prostate-Specific Antigen (PSA) progression using local laboratory values as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; b) Radiographic disease progression in soft tissue based on RECIST 1.1 criteria with or without PSA progression; c) Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
- Has progressed on at least one second generation anti-androgen therapy (e.g., enzalutamide, abiraterone).
- Has ongoing androgen deprivation with serum testosterone 5 years ago are eligible as long as there are no symptoms of graft-versus-host disease (GVHD).
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of Hepatitis B or known active Hepatitis C virus infection.
- Has a history or current evidence of a gastrointestinal condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the Investigator may significantly alter the absorption or metabolism of oral medications; any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, make administration of the study drugs hazardous, or make it difficult to monitor AEs such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
- Is pregnant or expecting to conceive or father children within the projected duration of the study.
- Has undergone major surgery and has not recovered adequately from any toxicity and/or complications from the intervention prior to starting study treatment.
- Has CRPC or MSS CRC and has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-P
Data sourced from ClinicalTrials.gov (NCT03473925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.