Melanoma Clinical Trial

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Summary

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 in participants with previously treated selected solid tumors (melanoma, colorectal cancer [CRC], hepatocellular carcinoma [HCC]) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

View Eligibility Criteria

Eligibility Criteria

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

Calcium (albumin-corrected) within normal range
Potassium within normal reference range
Magnesium less than or equal to (>=) 1.2 milligram per deciliter (mg/dL) or 0.5 millimoles per litre (mmol/L).

Melanoma cohort (Phase 2), participants must have:

Unresectable Stage III or Stage IV melanoma, not amenable to local therapy.
Received only 1 or, if known BRAF mut +ve, 2 lines of therapies prior to study enrollment and must have progressed on 1 prior BRAF inhibitor
No restriction with regards to PD-L1 and BRAF status
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)

HCC cohort (Phase 2), participants must have:

Stage B (not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment) or stage C based on Barcelona Clinic Liver Cancer [BCLC] staging System and Child-Pugh class A only.
Have received only 1 prior line of systemic therapy in the locally advanced or metastatic setting, and must have progressed on treatment with an anti-PD-1/L1 monoclonal antibodies (mAb) administered either as monotherapy, or in combination
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).

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. Participants with previously treated brain metastases may participate provided they 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), 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:

Osteoporosis with T-score <-2.5 by DXA scan
Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
Symptomatic hypercalcemia requiring bisphosphonate therapy
History of any fracture within 6 months prior to starting study drug
History of symptomatic vertebral fragility fracture or any fragility fracture
Moderate or severe morphometric vertebral fracture at baseline.
Any condition requiring orthopedic intervention.
Bone metastases not being treated with a bisphosphonate or denosumab
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:

clear invasion to bile duct or portal vein invasion of Vp4
symptomatic gastric or esophageal varices per Investigator's clinical judgement
history of hepatic encephalopathy within 6 months prior to starting study drug

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT05091346

Recruitment Status:

Recruiting

Sponsor:

Eisai Inc.

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There are 9 Locations for this study

See Locations Near You

University of California, Los Angeles
Los Angeles California, 90024, United States
Florida Cancer Specialists
Fort Myers Florida, 33916, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
SCRI Florida Cancer Specialists East
West Palm Beach Florida, 33401, United States
Emory University
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
Sarah Cannon Cancer Care in Nashville
Nashville Tennessee, 37203, United States
Eisai Trial Site 4
Chiba-shi , , Japan
Eisai Trial Site 6
Fukuoka , , Japan
Eisai Trial Site 1
Kashiwa , , Japan
Eisai Trial Site 3
Osaka , , Japan
Osaka Metropolitan University Hospital
Osaka , , Japan
Sapporo-Kosei General Hospital
Sapporo shi , , Japan
Eisai Trial Site 5
Shizouka , , Japan
Eisai Trial Site 2
Tokyo , , Japan
Eisai Trial Site 7
Tokyo , , Japan
Clínica Universidad de Navarra
Pamplona Navarra, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona , , Spain
Hospital Universitari Vall d'Hebron
Barcelona , , Spain
Hospital Clínico San Carlos
Madrid , , Spain
Hospital General Universitario Gregorio Maranon
Madrid , , Spain
Hospital Universitario de la Paz
Madrid , , Spain
Hospital Regional Universitario de Malaga - Hospital Universitario Virgen de la Victoria
Malaga , , Spain
Consorcio Hospital General Universitario de Valencia
Valencia , , Spain
The Royal Marsden NHS Foundation Trust - The Royal Marsden Hospital
Sutton Surrey, , United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT05091346

Recruitment Status:

Recruiting

Sponsor:


Eisai Inc.

How clear is this clinincal trial information?

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