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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001568-10 | EudraCT Number | ||
| MK-3475-C83 | Other Identifier | Merck Sharp & Dohme | |
| 2023-505425-14 | Registry Identifier | CTIS |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab.
The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer [CRC], hepatocellular carcinoma [HCC]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b and 2: E7386 + Pembrolizumab | Experimental | Participants will receive E7386 twice daily (BID) along with pembrolizumab 200 mg intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day treatment cycle until RP2D is determined in Phase 1b. The recommended dose for Phase 2 part of the study will be based on Phase 1b result. Participants will continue to receive study treatment in Phase 2 part until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study. |
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| Phase 2: E7386 + Pembrolizumab + Lenvatinib | Experimental | Participants will be randomized to receive E7386 Dose 1 (Cohort 1) or Dose 2 (Cohort 2) tablet, BID, orally in combination with pembrolizumab 200 mg Q3W IV infusion plus lenvatinib 8 mg capsule, orally, once daily (QD) continuously in 21-days treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or termination of the study. The dose of treatment depends on tolerability data of both Cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7386 | Drug | E7386 tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs) | DLT was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 based on investigator assessment. DLT was defined as any of the hematological or non-hematological toxicities events that: - Failure to administer greater than or equal to (>=) 75 percentage (%) of the planned dosage of E7386 as a result of treatment-related toxicity; - Any treatment-related toxicity that causes the participant to discontinue treatment, even if the toxicity does not meet DLT criteria; - Prolonged delay (greater than [>] 2 weeks) in initiating Cycle 2 due to treatment-related toxicities; - Any Grade 5 event or any death not clearly due to the underlying disease or extraneous causes. | Cycle 1 (Cycle length=21 days) |
| Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous. | Up to 30 days after last dose of study drug (up to 12.73 months) |
| Phase 1b Part: Number of Participants With Serious TEAEs | An SAE was any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening (i.e., the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). An SAE was also counted as a TEAE if it emerged up to 90 days after the participant's last dose of study drug, or up to 30 days following cessation of study drug if the participant initiated new anticancer therapy, whichever was earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) | BOR was defined as CR, PR, stable disease (SD), progressive disease (PD), and not applicable (NA)/not evaluable (NE) as per RECIST version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of >=5 mm. NA: No target lesions were identified at Screening. |
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Inclusion Criteria
Male or female, age >=18 years at the time of informed consent
Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) selected solid tumor for which prior standard systemic therapy has failed. Selected tumor types: melanoma (excluding uveal melanoma), CRC, HCC
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Must have disease progression on current or since the last anticancer treatment
At least one measurable lesion by computer tomography (CT) or magnetic imaging resonance (MRI) based on RECIST 1.1
Adequate organ function and serum mineral level per blood work as confirmed by the investigator
Melanoma cohort (Phase 2), participants must have:
CRC cohort (Phase 2), participants must have received at least 2 prior systemic therapies in adjuvant and/or metastatic setting (not exceeding 4 lines of therapies in the metastatic setting, progressed on at least 1 prior regimen in the metastatic setting or could not tolerate standard treatment)
Participants with HCC cohort (Phase 2) must have:
Must agree to take Vitamin D continuous supplementation as per local institutional guideline/ investigator's clinical discretion if their 25-hydroxyvitamin D levels are less than 10 nanogram per milliliter (ng/mL).
Triplet treatment cohorts only: Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP <=150/90 millimeter of mercury (mmHg) at Screening/Baseline and no change in antihypertensive medications within 1 week before starting treatment in this study.
Exclusion Criteria
Have present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to study drug administration. The participant can receive diuretic drugs as needed per the treating physician. Consult with the sponsor if the participant has more than trivial/trace fluid accumulation.
Prior treatment with E7386 or prior therapy with anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (example, CTLA-4, OX 40, CD137) that was discontinued due to a Grade 3 or higher immune-related (ir)AE
Participants with central nervous system (CNS) metastases are not eligible unless they are previously treated are radiologically stable, that is, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), and are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
Any active infection requiring systemic treatment
Have severe hypersensitivity to study drugs and/or any of its excipients
Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Have an active autoimmune disease that has required systemic treatment in the past 2 years
Have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Any bone disease/conditions as follows:
Active viral hepatitis (B or C) as demonstrated by positive serology for participants with melanoma and CRC. Dual active hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection at study entry for participants with HCC
Known to be human immunodeficiency virus (HIV) positive
Received blood/platelet transfusion or G-CSF within 4 weeks before study entry
For Melanoma only, participants with ocular melanoma are excluded. Note: Participants with mucosal melanoma will not exceed 20% of the enrolled participants in melanoma cohort in Phase 2.
For CRC only, participants are excluded if:
- have a tumor that is microsatellite instability high (MSI H)/ DNA mismatch repair-deficient (dMMR) positive
For HCC only, participants are excluded if:
For participants in the triplet treatment cohorts only:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California, Irvine Health |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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A total of 152 participants were screened, of which 63 were screen failures and 89 received study treatment.
Participants took part in the study at 25 investigative sites in Japan, United States, Spain, and United Kingdom from 27 October 2021 to 15 October 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg | Participants received E7386 100 milligrams (mg), tablets, orally, twice daily (BID), plus pembrolizumab 200 mg, intravenous (IV) infusion, every 3 weeks (Q3W) continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2023 | Oct 10, 2025 |
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| Pembrolizumab | Drug | Pembrolizumab IV infusion. |
|
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| Lenvatinib | Drug | Lenvatinib capsule. |
|
|
| Up to 90 days after last dose of study drug (up to 14.73 months) |
| Phase 2 Part: Objective Response Rate (ORR) | ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to less than [<] 10 millimeters [mm]). PR: At least a 30 percent (%) decrease in sum of the diameters (SOD) of target lesions, taking as reference the screening SOD. Additionally, progression of target lesions must not be present. | Up to 20.40 months |
| Up to 11.73 months |
| Phase 1b and Phase 2 Parts: Duration of Response (DOR) | DOR was defined as the time from the first documentation of CR or PR to the first documentation of PD or death due to any cause (whichever occurs first), in participants with confirmed CR or PR per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of >=5 mm. | Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months |
| Phase 1b and Phase 2 Parts: Disease Control Rate (DCR) | DCR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or SD (after >=5 weeks from the first dose) as per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of >=5 mm. | Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months |
| Phase 1b and Phase 2 Parts: Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or durable SD (duration of SD >=23 weeks) per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. | Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months |
| Phase 2 Part: Number of Participants With TEAEs and Treatment-related TEAEs | A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous. Related TEAEs was defined as AE for which a causal relationship between the study drug and the AE was a reasonable possibility. | Up to 30 days after last dose of study drug (up to 21.40 months) |
| Phase 1b Part, Cmax: Maximum Observed Plasma Concentration for E7386 When Co-administered With Pembrolizumab | Cmax was defined as the maximum plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis. | Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
| Phase 1b Part, Tmax: Time to Reach the Maximum Plasma Concentration for E7386 When Co-administered With Pembrolizumab | Tmax was defined as the time to reach maximum observed plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis. | Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
| Phase 1b Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 When Co-administered With Pembrolizumab | AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 (pre-dose) to time of last quantifiable concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis. | Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
| Phase 1b Part, CLss/F: Apparent Clearance From Plasma at Steady State for E7386 When Co-administered With Pembrolizumab | CLss/F for E7386 when co-administered with Pembrolizumab was reported. PK parameters were derived by noncompartmental analysis. | Cycle 1 Day 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
| Orange |
| California |
| 92868 |
| United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| SCRI Florida Cancer Specialists East | West Palm Beach | Florida | 33401 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Barbara Ann Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Rutgers cancer Institute of NJ | New Brunswick | New Jersey | 08901 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Providence Medical Center Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| Tennessee Oncology PPLC | Nashville | Tennessee | 37203 | United States |
| Chiba University Hospital | Chiba | Japan |
| National Cancer Center Hospital | Chūōku | Japan |
| Kurume University Hospital | Fukuoka | Japan |
| National Cancer Center Hospital East | Kashiwa | Japan |
| Osaka Metropolitan University Hospital | Osaka | Japan |
| Kindai University Hospital | Ōsaka-sayama | Japan |
| Sapporo-Kosei General Hospital | Sapporo | Japan |
| Shizuoka Cancer Center Hospital | Shizouka | Japan |
| Toranomon Hospital | Tokyo | Japan |
| Hospital Regional Universitario de Malaga | Málaga | Avenida Carolos Haya S/n | Spain |
| Hospital Clínico San Carlos | Madrid | Calle Profesor Martín Lagos | Spain |
| Clínica Universidad de Navarra | Pamplona | Navarre | Spain |
| Hospital Universitario de Badajoz | Badajoz | Spain |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain |
| Hospital Universitario de la Paz | Madrid | Spain |
| Consorcio Hospital General Universitario de Valencia | Valencia | Spain |
| Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom |
| Imperial College London - Hammersmith Hospital | London | United Kingdom |
| Royal Free Hospital NHS Foundation Trust | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| FG001 | Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg | Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| FG002 | Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg | Participants with hepatocellular carcinoma (HCC) received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| FG003 | Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg | Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| FG004 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with colorectal cancer (CRC) received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
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| NOT COMPLETED |
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Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg | Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| BG001 | Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg | Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| BG002 | Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg | Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| BG003 | Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg | Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| BG004 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Phase 1b Part: Number of Participants With Dose-limiting Toxicities (DLTs) | DLT was graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 based on investigator assessment. DLT was defined as any of the hematological or non-hematological toxicities events that: - Failure to administer greater than or equal to (>=) 75 percentage (%) of the planned dosage of E7386 as a result of treatment-related toxicity; - Any treatment-related toxicity that causes the participant to discontinue treatment, even if the toxicity does not meet DLT criteria; - Prolonged delay (greater than [>] 2 weeks) in initiating Cycle 2 due to treatment-related toxicities; - Any Grade 5 event or any death not clearly due to the underlying disease or extraneous causes. | The DLT Analysis Set included all participants in Phase 1b part who had received study drug as planned (that is [i.e.], complete at least 75% of the planned E7386) in Cycle 1, or who experienced a DLT. | Posted | Count of Participants | Participants | Cycle 1 (Cycle length=21 days) |
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| Primary | Phase 1b Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous. | Safety Analysis Set included all participants who received at least 1 dose of any study drug. | Posted | Count of Participants | Participants | Up to 30 days after last dose of study drug (up to 12.73 months) |
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| Primary | Phase 1b Part: Number of Participants With Serious TEAEs | An SAE was any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening (i.e., the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). An SAE was also counted as a TEAE if it emerged up to 90 days after the participant's last dose of study drug, or up to 30 days following cessation of study drug if the participant initiated new anticancer therapy, whichever was earlier. | Safety Analysis Set included all participants who received at least 1 dose of any study drug. | Posted | Count of Participants | Participants | Up to 90 days after last dose of study drug (up to 14.73 months) |
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| Primary | Phase 2 Part: Objective Response Rate (ORR) | ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to less than [<] 10 millimeters [mm]). PR: At least a 30 percent (%) decrease in sum of the diameters (SOD) of target lesions, taking as reference the screening SOD. Additionally, progression of target lesions must not be present. | Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 20.40 months |
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| Secondary | Phase 1b Part: Percentage of Participants With Best Overall Response (BOR) | BOR was defined as CR, PR, stable disease (SD), progressive disease (PD), and not applicable (NA)/not evaluable (NE) as per RECIST version 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of >=5 mm. NA: No target lesions were identified at Screening. | Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug. | Posted | Number | percentage of participants | Up to 11.73 months |
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| Secondary | Phase 1b and Phase 2 Parts: Duration of Response (DOR) | DOR was defined as the time from the first documentation of CR or PR to the first documentation of PD or death due to any cause (whichever occurs first), in participants with confirmed CR or PR per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of >=5 mm. | Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug. Here, "Overall Number of Participants Analyzed" signifies participants who had CR or PR. | Posted | Median | 95% Confidence Interval | months | Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months |
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| Secondary | Phase 1b and Phase 2 Parts: Disease Control Rate (DCR) | DCR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or SD (after >=5 weeks from the first dose) as per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. PD: At least a 20% increase in the SOD of target lesions, taking as reference nadir SOD (or the screening, if screening is nadir value). In addition to relative increase of 20% in SOD, the SOD must also demonstrate an absolute increase of >=5 mm. | Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months |
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| Secondary | Phase 1b and Phase 2 Parts: Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants who had a best overall response of confirmed CR or PR, or durable SD (duration of SD >=23 weeks) per RECIST 1.1. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal (i.e., decrease in short axis to <10 mm). PR: At least a 30% decrease in SOD of target lesions, taking as reference screening SOD. Additionally, progression of target lesions must not be present. SD: Neither sufficient shrinkage of target lesions to qualify for PR, nor sufficient increase to qualify for PD. | Efficacy Analysis Set included all participants with measurable disease at Baseline who received at least 1 dose of any study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Phase 1b Part: Up to 11.73 months; Phase 2 Part: Up to 20.40 months |
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| Secondary | Phase 2 Part: Number of Participants With TEAEs and Treatment-related TEAEs | A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, or up to 30 days following last dose of study drug, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment or up to 30 days following last dose of study drug, relative to the pretreatment state, when the AE was continuous. Related TEAEs was defined as AE for which a causal relationship between the study drug and the AE was a reasonable possibility. | Safety Analysis Set included all participants who received at least 1 dose of any study drug. | Posted | Count of Participants | Participants | Up to 30 days after last dose of study drug (up to 21.40 months) |
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| Secondary | Phase 1b Part, Cmax: Maximum Observed Plasma Concentration for E7386 When Co-administered With Pembrolizumab | Cmax was defined as the maximum plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis. | Pharmacokinetic Analysis Set included all participants who had received at least 1 dose of study drug and had at least 1 evaluable plasma E7386 concentration. As planned, this PK parameter was assessed in Phase 1b Part only. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Phase 1b Part, Tmax: Time to Reach the Maximum Plasma Concentration for E7386 When Co-administered With Pembrolizumab | Tmax was defined as the time to reach maximum observed plasma concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis. | Pharmacokinetic Analysis Set included all participants who had received at least 1 dose of study drug and had at least 1 evaluable plasma E7386 concentration. As planned, this PK parameter was assessed in Phase 1b Part only. | Posted | Median | Full Range | hour | Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Phase 1b Part, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386 When Co-administered With Pembrolizumab | AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 (pre-dose) to time of last quantifiable concentration for E7386 when co-administered with Pembrolizumab. PK parameters were derived by noncompartmental analysis. | Pharmacokinetic Analysis Set included all participants who had received at least 1 dose of study drug and had at least 1 evaluable plasma E7386 concentration. As planned, this PK parameter was assessed in Phase 1b Part only. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Cycle 1 Days 1 and 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
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| Secondary | Phase 1b Part, CLss/F: Apparent Clearance From Plasma at Steady State for E7386 When Co-administered With Pembrolizumab | CLss/F for E7386 when co-administered with Pembrolizumab was reported. PK parameters were derived by noncompartmental analysis. | Pharmacokinetic Analysis Set included all participants who had received at least 1 dose of study drug and had at least 1 evaluable plasma E7386 concentration. As planned, this PK parameter was assessed in Phase 1b Part at Cycle 1 Day 8 only. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour | Cycle 1 Day 8: Pre-dose up to 12 hours post-dose (Cycle 1 length=21 days) |
|
Non-serious: Up to 30 days after last dose of the study drug (up to 12.73 months for Phase 1b and up to 21.40 months for Phase 2); All-cause Mortality and SAEs: Up to 90 days after last dose of the study drug (up to 14.73 months for Phase 1b and 23.40 months for Phase 2)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b, Dose Escalation: E7386 100 mg + Pembrolizumab 200 mg | Participants received E7386 100 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. | 6 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg | Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. | 5 | 6 | 2 | 6 | 6 | 6 |
| EG002 | Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg | Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. | 8 | 17 | 7 | 17 | 17 | 17 |
| EG003 | Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg | Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. | 16 | 29 | 5 | 29 | 28 | 29 |
| EG004 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. | 26 | 31 | 10 | 31 | 30 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Organ failure | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | 1-888-274-2378 | esi_medinfo@eisai.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2024 | Oct 10, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D006528 | Carcinoma, Hepatocellular |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717377 | E-7386 |
| C582435 | pembrolizumab |
| C531958 | lenvatinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program.
|
|
| OG002 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
|
|
Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
|
|
| OG001 |
| Phase 1b, Dose Escalation: E7386 120 mg + Pembrolizumab 200 mg |
Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG002 | Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg | Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG003 | Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg | Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG004 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
|
|
Participants received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG002 | Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg | Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG003 | Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg | Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG004 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
|
|
| OG002 | Phase 2, Dose Expansion, HCC: E7386 120 mg + Pembrolizumab 200 mg | Participants with HCC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG003 | Phase 2, Dose Expansion, Melanoma: E7386 120 mg + Pembrolizumab 200 mg | Participants with melanoma received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
| OG004 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
|
|
| OG002 | Phase 2, Dose Expansion, CRC: E7386 120 mg + Pembrolizumab 200 mg | Participants with CRC received E7386 120 mg, tablets, orally, BID, plus pembrolizumab 200 mg, IV infusion, Q3W continuously in 21-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice, or discontinuation of the study program. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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