NCT03752723

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_1

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 27, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

4.1 years

First QC Date

November 19, 2018

Last Update Submit

March 1, 2024

Conditions

Triple Negative Breast Cancer

Keywords

Breast cancerTNBC

Outcome Measures

Primary Outcomes (3)

  • Incidence and nature of DLTs

    To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab

    during the first 5 weeks

  • Incidence, nature and severity of adverse events

    graded according to NCI CTCAE v5.0

    up to 24month

  • Objective response rate (ORR)

    defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1

    up to 24month

Study Arms (2)

combination with CPA, GX-I7, and pembrolizumab

EXPERIMENTAL

Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab

Drug: GX-I7Drug: Pembrolizumab(KEYTRUDA®)Drug: Cyclophosphamide

combination with GX-I7, and pembrolizumab

EXPERIMENTAL

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

Drug: GX-I7Drug: Pembrolizumab(KEYTRUDA®)

Interventions

GX-I7DRUG

i.m.

Also known as: Efineptakin alfa
combination with CPA, GX-I7, and pembrolizumabcombination with GX-I7, and pembrolizumab
Pembrolizumab(KEYTRUDA®)DRUG

i.v.

Also known as: KEYTRUDA®, MK-3745
combination with CPA, GX-I7, and pembrolizumabcombination with GX-I7, and pembrolizumab
CyclophosphamideDRUG

i.v.

combination with CPA, GX-I7, and pembrolizumab

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Ajou Medical Center

Suwon, Gyeonggi-do, South Korea

Location

National Cancer Center

Goyang-si, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul ST.Mary's Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsBreast Neoplasms

Interventions

efineptakin alfapembrolizumabCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 26, 2018

Study Start

March 27, 2019

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

March 5, 2024

Record last verified: 2024-02

Locations

KR(12)