A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
Colon/Rectal Cancer
Liver Cancer / Hepatoblastoma
Melanoma
18 Years and older, Male and Female
E7386-G000-201 (primary)
NCI-2022-02226
2021-001568-10
KEYNOTE-C83
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 (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.
Eligibility
- 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 BRAF mut +ve, 2 lines of therapies locally advanced or metastatic setting prior to study enrolment. Note: Adjuvant anti-PD-1/PD-L1 mAb/ BRAF inhibitor treatment will be counted as prior line of treatment if relapse occurred during active treatment or within 12 weeks of treatment discontinuation.
- 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:
- 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).
- 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.