Biomarker Study of PDR001 in Combination With MCS110 in Gastric Cancer

NCT03694977 | Unknown Phase 2 DMC

• 1 other identifier: H-1710-062-893
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

\<Background\>

• 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

Conditions

Gastric Cancer

Keywords

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Identification of potential biomarkers of MCS110 in combination with PDR001

  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.

  3weeks

Secondary Outcomes (7)

• Objective response rate

  6weeks

• Immune-related response rate

  6weeks

• Progression-free survival

  6weeks

• Duration of response

  6weeks

• Disease control rate

  6weeks

Study Arms (1)

MCS110/PDR001 combination

EXPERIMENTAL

Drug: MCS110/PDR001 combination

Interventions

MCS110/PDR001 combination DRUG

MCS110 7.5mg/kg iv since 1st cycle PDR001 300 mg iv since 2nd cycle Q 3weeks

MCS110/PDR001 combination

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Male or female patient, age ≥ 20 years
• Pathologically confirmed unresectable or recurrent gastric cancer
• Patients who have previously treated with at least 2 kinds of palliative chemotherapy
• Patients must have measurable disease by RECIST 1.1
• Patients must have easily assessable tumor sites for fresh biopsy
• ECOG performance status of 0-1
• Adequate bone marrow, organ function and laboratory parameters:
• Absolute neutrophil count (ANC) ≥ 1.0 x 109/L,
• Hemoglobin (Hgb) ≥ 8 g/dL without transfusions,
• Platelets (PLT) ≥ 75 x 109/L without transfusions,
• AST and ALT ≤ 3 × upper limit of normal (ULN),
• Total bilirubin ≤ 1.5 × ULN, (Patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainage)
• Creatinine ≤ 1.5 mg/dL
• Adequate cardiac function:

You may not qualify if:

• \. History of previous immune-related abnormal reaction or current interstitial lung disease, noninfective interstitial lung disease or drug-induced interstitial pneumonitis 11. Patients who failed immune check point inhibitors which includes PD-1, PDL-1, CTLA4 antagonist and investigational drugs.
• \. Patients requiring chronic treatment with systemic steroid therapy or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency.
• \. Use of any live vaccines against infectious disease within 4 weeks of initiation of study treatment.
• \. Major surgery within 2 weeks of the first dose of study treatment 15. Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited field.
• \. Systemic chemotherapy within 3 weeks of the first dose of study treatment. In case of mitomycin Cor nitrosoureas, 4 weeks rest should be needed.
• \. Presence of ≥ CTCAE Gr2 hematologic toxicity or ≥ CTCAE Gr3 non-hematologic toxicity(except for alopecia) caused by previous chemotherapy 18. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior start or study drug. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment.
• \. Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• \. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 150 days after the last dose of PDR001 or 90 days after the last dose of MCS110 for patients who stopped PDR001 and continued MCS110 alone for more than 60 days.
• \. Sexually active males unless they use a condom during intercourse while taking treatment and for150 days after the last dose of PDR001 or 90 days after the last dose of MCS110 for patients who stopped PDR001 and continued MCS110 alone for more than 60 and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yung-Jue Bang

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Jue Bang, MD, PhD

CONTACT

82-2-2072-2390; bangyj@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: MCS110/PDR001 combination

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: October 3, 2018
• Study Start: January 17, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)