Triple Negative Breast Cancer
Conditions
Keywords
Breast cancer, TNBC
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
Interventions
Sponsors
Merck Sharp & Dohme LLC
Genexine, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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). 2. Subject must have received anthracycline and taxane based chemotherapy for TNBC 3. Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology. 4. Female subjects, age ≥ 19 years at the time of consent. Key
Exclusion criteria
1. Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed