Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)
NCT03752723 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2024-03-05
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
Interventions
- DRUG
-
GX-I7
i.m.
- DRUG
-
Pembrolizumab(KEYTRUDA®)
i.v.
- DRUG
-
i.v.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Genexine, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-27
- Primary Completion
- 2023-05-11
- Completion
- 2023-05-11
Countries
- South Korea
Study Locations
More Related Trials
-
Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
NCT06353997 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
NCT06797635 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC
NCT03289819 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
NCT06078384 ·Status: RECRUITING ·Phase: PHASE2
-
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
NCT06976944 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
NCT03797326 ·Status: COMPLETED ·Phase: PHASE2
-
Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
NCT04913337 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors
NCT00722293 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
NCT03719326 ·Status: COMPLETED ·Phase: PHASE1
-
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
NCT05812807 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
NCT03725059 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT05681728 ·Status: UNKNOWN ·Phase: PHASE2
-
The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel
NCT07187674 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer
NCT03515798 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC
NCT06817525 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
NCT05675579 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)
NCT02447003 ·Status: COMPLETED ·Phase: PHASE2
-
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
NCT07178730 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
NCT04787042 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab
NCT06371807 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
NCT02977468 ·Status: RECRUITING ·Phase: PHASE1
-
Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC
NCT07011823 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
NCT07178171 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
NCT05852691 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer
NCT06162351 ·Status: TERMINATED ·Phase: PHASE2