Biomarker Study of PDR001 in Combination With MCS110 in Gastric Cancer
Status:
Unknown status
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
1. 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.
2. Current status of immunotherapy development in gastric cancer
3. The importance of tumor microenvironment
4. The role of polarized macrophage in TME
5. The role of polarized macrophage in gastric cancer
6. 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.
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.