| Primary | 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. | All participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who were administered at least 1 dose of study medicine. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to approximately 2 years | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| | | Title | Measurements |
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| - OG0003.9(0.5 to 13.5)
- OG0011.9(0.0 to 9.9)
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| Primary | 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 | Participants who complete cycle 1 without any discontinuation, or discontinues from the study prior to completing all the safety evaluations in cycle 1 due to treatment-related adverse events, or if participants receive >=75% of the total pembrolizumab infusion and/or navarixin in cycle, or If the participants experience any DLT in AE. | Posted | | Count of Participants | | Participants | | Up to 21 days | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). |
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| Primary | 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. | All participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to approximately 27 months | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Primary | 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. | All participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to approximately 2 years | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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. | All participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who were administered at least 1 dose of study medicine. Only participants with progressive disease per RECIST 1.1 are included. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to approximately 2 years | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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). | All participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who were administered at least 1 dose of study medicine. | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 2 years | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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). | All participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who were administered at least 1 dose of study medicine. | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 2 years | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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). | All participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who were administered at least 1 dose of study medicine. | Posted | | Median | 95% Confidence Interval | Months | | Up to approximately 2 years | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | Absolute Neutrophil Counts (ANC) | Peripheral blood neutrophil counts were performed at Cycle 1 Day 3: Predose, to determine the concentration of ANC. | Participants who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance includes such considerations as exposure to treatment, availability of measurements, and the absence of major protocol violations | Posted | | Mean | 95% Confidence Interval | 10^9 cells/L | | Day 3: Predose | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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 | Participants with available AUC-inf data, who complied with the protocol sufficiently to ensure that their data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance includes, but is not limited to, exposure to treatment, availability of measurements, and absence of major protocol violations. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | 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) | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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. | Participants with available AUC-last data, who complied with the protocol sufficiently to ensure that their data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance includes, but is not limited to, exposure to treatment, availability of measurements, and absence of major protocol violations. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | 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) | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | Navarixin Maximum Plasma Concentration (Cmax) | Plasma samples from participants with selected advanced/metastatic solid tumors were collected to determine the navarixin plasma Cmax. | Participants with available Cmax data, who complied with the protocol sufficiently to ensure that their data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance includes, but is not limited to, exposure to treatment, availability of measurements, and absence of major protocol violations. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 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) | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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| Secondary | 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. | Participants with available Ctrough data, who complied with the protocol sufficiently to ensure that their data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance includes, but is not limited to, exposure to treatment, availability of measurements, and absence of major protocol violations. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Cycle 2 Day 21 (Up to approximately 43 days) | | | | ID | Title | Description |
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| OG000 | Navarixin 30 mg + Pembrolizumab 200 mg | 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). | | OG001 | Navarixin 100 mg + Pembrolizumab 200 mg | 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). |
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