Status:
COMPLETED
Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)
Lead Sponsor:
Genexine, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed...
Eligibility Criteria
Inclusion
- Key
- Triple negative must be defined as guidelines of American Society of Clinical Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) \< 1% positive tumor nuclei, Progesterone Receptor (PR) \< 1% positive tumor nuclei, and negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization (ISH).
- Subject must have received anthracycline and taxane based chemotherapy for TNBC
- Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology.
- Female subjects, age ≥ 19 years at the time of consent.
- Key
Exclusion
- Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03752723
Start Date
March 27 2019
End Date
May 11 2023
Last Update
March 5 2024
Active Locations (12)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
2
Ajou Medical Center
Suwon, Gyeonggi-do, South Korea
3
National Cancer Center
Goyang-si, South Korea
4
Gachon University Gil Medical Center
Incheon, South Korea