A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    116
  • sponsor
    Eisai Co., Ltd.
Updated on 16 July 2021
Investigator
Inquiry Service
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Eisai Trial Site #17 (3.0 mi away) Contact
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Summary

The primary purpose of the study is to evaluate safety and tolerability and to determine recommended Phase 2 dose (RP2D) of E7389-LF in combination with nivolumab in Phase 1b part, and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in Phase 2 part in each tumor type.

Details
Condition Solid Neoplasms
Treatment Nivolumab, E7389-LF
Clinical Study IdentifierNCT04078295
SponsorEisai Co., Ltd.
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase 1b part only: Participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (participants who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable)
Phase 2 part only: Nonresectable specific solid tumor participants with confirmed diagnosis who showed disease progression by investigator's assessment during or after 1st line chemotherapy and did not receive any other systemic chemotherapy to advanced/recurrent disease
Participants who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug (If a pre-treatment biopsy cannot be obtained due to safety issue, then an archival tumor tissue sample may be submitted)
Life expectancy of greater than or equal to (>=) 12 weeks
Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) 0-1
Phase 2 part only: At least one measurable lesion based on RECIST 1.1 (Lesions that have had radiotherapy or loco-regional therapies must show evidence of progressive disease to be deemed a measurable lesion)

Exclusion Criteria

Diagnosed with meningeal carcinomatosis
Participants with brain or subdural metastases or invasion are not eligible
Participants with any active, known, or suspected autoimmune disease
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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