Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT03752723
- Lead Sponsor
- Genexine, Inc.
- 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 TNBC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 84
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description combination with CPA, GX-I7, and pembrolizumab Pembrolizumab(KEYTRUDA®) Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab combination with CPA, GX-I7, and pembrolizumab GX-I7 Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab combination with GX-I7, and pembrolizumab Pembrolizumab(KEYTRUDA®) Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA) combination with CPA, GX-I7, and pembrolizumab Cyclophosphamide Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab combination with GX-I7, and pembrolizumab GX-I7 Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA)
- Primary Outcome Measures
Name Time Method Incidence and nature of DLTs during the first 5 weeks To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab
Incidence, nature and severity of adverse events up to 24month graded according to NCI CTCAE v5.0
Objective response rate (ORR) up to 24month defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Ajou Medical Center
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul ST.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of