Biomarker Study of PDR001 in Combination With MCS110 in Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03694977|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : April 9, 2019
Current status of treatment options in advanced gastric cancer.
- The cytotoxic chemotherapy, usually fluoropyrimidine + platinum combination regimen is current standard of care. In case of HER2(+) gastric cancer, the addition of trastuzumab on top of cytotoxic chemotherapy is standard of care.
- In second-line setting, the cytotoxic chemotherapy in combination with Ramucirumab improved the patients' survival compared with cytotoxic chemotherapy alone.
- There are few treatment options for gastric cancer patients who have been treated with more than two lines of palliative chemotherapy. Patients with good performance status even after failure to 2 kinds of palliative chemotherapy still need the active anticancer treatment options. Therefore, this is the high unmet medical need.
- Current status of immunotherapy development in gastric cancer
- The importance of tumor microenvironment
- The role of polarized macrophage in TME
- The role of polarized macrophage in gastric cancer
- Potential of combination of PD1 inhibitor and CSF-1 inhibitor
Based on these rationales, we hypothesized that the combination of PD1 inhibitor and CSF1R inhibitor might be synergistic in gastric cancer. However, the exact in vivo immune modulation by each inhibitor has not been revealed so far. Therefore, we will conduct this "biomarker study of PDR001 in combination with MCS110 in gastric cancer" to see the biologic dynamic modulation with MCS110 and combination (MCS110/PDR001) and to see preliminary efficacy signal with this combination.
<Trial objectives> Primary objective: To see biomarker changes (PDL1, TAM, TIL) by MCS110 monotherapy and MCS110/PDR001 combination (To see the biomarker changes by MCS110 monotherapy at first, then, by MCS110/PDR001 combination in gastric cancer) Secondary objective: To see preliminary efficacy (ORR, irRR, PFS, DOR, DCR, OS) and safety.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: MCS110/PDR001 combination||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||MCS110/PDR001 combination|
|Masking:||None (Open Label)|
|Official Title:||Biomarker Study of PDR001 in Combination With MCS110 in Gastric Cancer|
|Actual Study Start Date :||January 17, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|Experimental: MCS110/PDR001 combination||
Drug: MCS110/PDR001 combination
MCS110 7.5mg/kg iv since 1st cycle PDR001 300 mg iv since 2nd cycle Q 3weeks
- Identification of potential biomarkers of MCS110 in combination with PDR001 [ Time Frame: 3weeks ]The current study explores potential biomarkers of MCS110 in combination with PDR001 that predict tumor response in the tumor tissue and blood of patients with gastric cancer.
- Objective response rate [ Time Frame: 6weeks ]According to RECIST v1.1 criteria
- Immune-related response rate [ Time Frame: 6weeks ]According to RECIST v1.1 criteria
- Progression-free survival [ Time Frame: 6weeks ]Time from randomization until disease progression or death
- Duration of response [ Time Frame: 6weeks ]Time from documentation of tumor response to disease progression
- Disease control rate [ Time Frame: 6weeks ]The percentage of patients who have achieved complete response, partial response and stable disease
- Overall survival [ Time Frame: 3months ]Time from randomization until death from any cause
- Safety as measured by number and grade of toxicity events [ Time Frame: 3weeks ]According to CTCAE v4.03
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694977
|Contact: Yung-Jue Bang, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Yung-Jue Bang 82-2-2072-2390 email@example.com|
|Principal Investigator:||Yung-Jue Bang||Seoul National University Hospital|