Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)

NCT ID: NCT03752723

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2023-05-11

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

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combination with CPA, GX-I7, and pembrolizumab

Experimental: combination

Assigned interventions: CPA, GX-I7 and pembrolizumab

Group Type: EXPERIMENTAL

GX-I7

Intervention Type: DRUG

i.m.

Pembrolizumab(KEYTRUDA®)

Intervention Type: DRUG

i.v.

Cyclophosphamide

Intervention Type: DRUG

i.v.

combination with GX-I7, and pembrolizumab

Experimental: combination

Assigned interventions: GX-I7 and pembrolizumab (without CPA)

Group Type: EXPERIMENTAL

GX-I7

Intervention Type: DRUG

i.m.

Pembrolizumab(KEYTRUDA®)

Intervention Type: DRUG

i.v.

Interventions

GX-I7

i.m.

Intervention Type: DRUG

Pembrolizumab(KEYTRUDA®)

i.v.

Intervention Type: DRUG

Cyclophosphamide

i.v.

Intervention Type: DRUG

Other Intervention Names

Efineptakin alfa; KEYTRUDA®; MK-3745

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou Medical Center

Suwon, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul ST.Mary's Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KEYNOTE-899

Identifier Type: OTHER

Identifier Source: secondary_id

MK-3475-899

Identifier Type: OTHER

Identifier Source: secondary_id

GX-I7-CA-006

Identifier Type: -

Identifier Source: org_study_id