Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

NCT ID: NCT04592211

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2026-05-31

Brief Summary

Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.

Detailed Description

Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.

Conditions

Gastric Cancer Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

olaparib+pembrolizumab+paclitaxel

olaparib+pembrolizumab+paclitaxel

Group Type: EXPERIMENTAL

olaparib+pembrolizumab+paclitaxel

Intervention Type: DRUG

olaparib, 100\~200mg, PO, bid, continuous Pembrolizumab 200mg, IV, q 3 weeks Paclitaxel 80mg/m2 IV, Q weekly

Interventions

olaparib+pembrolizumab+paclitaxel

olaparib, 100\~200mg, PO, bid, continuous Pembrolizumab 200mg, IV, q 3 weeks Paclitaxel 80mg/m2 IV, Q weekly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Provided written informed consent for treatment.

2. Age ≥ 19 years old

3. measurable or evaluable disease based on RECIST 1.1. Lesions

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.

5. Adequate organ function as defined by the following criteria:

6. A life expectancy of at least 3 months

7. Is able to swallow and retain orally administered medications

8. Failed first-line trastuzumab treatment for HER2 positive patients

9. Highly effective contraception for both male and female subjects if the risk of conception exists.

10. Left ventricular ejection fraction (LVEF) ≥50%

Exclusion Criteria

1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation

2. Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.

3. Has received prior radiotherapy within 2 weeks of start of study treatment.

4. Has received a live vaccine within 30 days prior to the first dose of study drug.

5. Is currently participating in or has participated in a study of an investigational agent including trastuzumab or has used an investigational device within 4 weeks prior to the first dose of study treatment.

6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.

7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.

8. Has known active CNS metastases and/or carcinomatous meningitis.

9. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, PARP inhibitor and paclitaxel.

10. Has active autoimmune disease that has required systemic treatment in the past 2 years

11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

12. Has an active infection requiring systemic therapy.

13. Has a known history of Human Immunodeficiency Virus (HIV).

14. Has an active of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive and HBV titer >2000 IU/ml) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.

15. Has an active TB (Bacillus Tuberculosis) with treatment.

16. Participant has received previous allogenic bone-marrow, tissue/solid organ transplant or double umbilical cord transplantation (dUCBT).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Sun Young Rha

MD, Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sun Young Rha, MD.Ph.D

Role: PRINCIPAL_INVESTIGATOR

Yonsei Cencer center, Yonsei University Collrge of Medicine

Locations

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sun Young Rha, MD. Ph.D

Role: CONTACT

rha7655@yuhs.ac

82-2-2228-8053

Facility Contacts

Sun Young Rha, Ph.D

Role: primary

Other Identifiers

4-2020-0544

Identifier Type: -

Identifier Source: org_study_id