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

Status
Active
Cancer Type
Colon/Rectal Cancer
Liver Cancer / Hepatoblastoma
Melanoma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05091346
Protocol IDs
E7386-G000-201 (primary)
NCI-2022-02226
2021-001568-10
KEYNOTE-C83
Study Sponsor
Eisai Inc

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.

Eligibility

  1. Male or female, age >=18 years at the time of informed consent
  2. 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
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  4. Must have disease progression on current or since the last anticancer treatment
  5. At least one measurable lesion by computer tomography (CT) or magnetic imaging resonance (MRI) based on RECIST 1.1
  6. Adequate organ function and serum mineral level per blood work
  7. Melanoma cohort (Phase 2), participants must have:
  8. Unresectable Stage III or Stage IV melanoma, not amenable to local therapy.
  9. 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
  10. 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)
  11. HCC cohort (phase 2), participants must have:
  12. Barcelona Clinic Liver Cancer (BCLC) Stage B (not amenable for transarterial chemoembolization [TACE]) or Stage C and Child Pugh class A
  13. Has 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
**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.
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