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

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ClinicalTrials.gov Identifier: NCT03752723
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: GX-I7 Drug: Pembrolizumab Drug: cyclophosphamide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: combination with CPA, GX-I7, and pembrolizumab

Experimental: combination

Assigned interventions: CPA, GX-I7 and pembrolizumab

Drug: GX-I7
i.m.

Drug: Pembrolizumab
i.v.

Drug: cyclophosphamide
i.v.

Experimental: combination with GX-I7, and pembrolizumab

Experimental: combination

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

Drug: GX-I7
i.m.

Drug: Pembrolizumab
i.v.




Primary Outcome Measures :
  1. Incidence and nature of DLTs [ Time Frame: during the first 5 weeks ]
    To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab

  2. Incidence, nature and severity of adverse events [ Time Frame: up to 24month ]
    graded according to NCI CTCAE v5.0

  3. Objective response rate (ORR) [ Time Frame: up to 24month ]
    defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752723


Contacts
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Contact: Minkyu Heo +82 31 628 3340 mkheo@genexine.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of
Contact: JeeHyun Kim, MD       jhkimmd@snu.ac.kr   
Ajou Medical Center Active, not recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Korea, Republic of
Contact: Keun Seok Lee, MD       kslee@ncc.re.kr   
Principal Investigator: Keun Seok Lee, MD         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Hee Kyung Ahn, MD       hkahn.onco@gmail.com   
Principal Investigator: Hee Kyung Ahn, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: SungBae Kim, MD       sbkim3@amc.seoul.kr   
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyoung Eun Lee, MD       oncolee@ewha.ac.kr   
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: JeeHung Kim, MD       OK8504@yuhs.ac   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyong Hwa Park, MD       khpark@korea.ac.kr   
Principal Investigator: Kyong Hwa Park, MD         
Korea University Guro Hospital Active, not recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: YoungHyuck Im, MD       yh00.im@samsung.com   
Principal Investigator: YoungHyuck Im, MD         
Seoul ST.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: JiEun Lee, MD       befamiliar@catholic.ac.kr   
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joohyuk Sohn, MD       ONCOSOHN@yuhs.ac   
Principal Investigator: Joohyuk Sohn, MD         
Sponsors and Collaborators
Genexine, Inc.
Merck Sharp & Dohme Corp.
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT03752723    
Other Study ID Numbers: GX-I7-CA-006
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Genexine, Inc.:
Breast cancer
TNBC
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Pembrolizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological