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Pembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901301
Recruitment Status : Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hyun Cheol Chung, Yonsei University

Tracking Information
First Submitted Date  ICMJE September 11, 2016
First Posted Date  ICMJE September 15, 2016
Last Update Posted Date January 14, 2020
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • The recommended dose of phase II [ Time Frame: 4 weeks ]
  • The overall response rate using RECIST 1.1 [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • Duration of response [ Time Frame: 1 year ]
  • Time to response [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pembrolizumab, Trastuzumab, HER2 Positive Gastric Cancer
Official Title  ICMJE A Phase Ib/II Study of First Line Pembrolizumab in Combination With Trastuzumab, Capecitabine, and Cisplatin in HER2 Positive Gastric Cancer
Brief Summary

Gastric cancer is one of the major health problems worldwide, and one of the leading cause of death especially in Asia. Though the cytotoxic chemotherapy is the main treatment option, newer and molecularly targeted agents are recently incorporated to improve the survival outcome. Human epidermal growth factor receptor 2 (HER2, ErbB2) is a transmembrane tyrosine kinase receptor and is overexpressed or amplified in 10-20% of gastric cancer. Recently, Trastuzumab for Gastric Cancer (ToGA) study reported the clinical benefit of trastuzumab for HER2 positive gastric cancer patients. However, because the majority of patients develop intrinsic or acquired resistance within 1 year, elucidating the molecular mechanisms for trastuzumab resistance is warranted to improve the survival outcome of HER2 positive gastric cancer patients.

A growing body of preclinical and clinical evidence shows that the immune system contributes substantially to the therapeutic effects of "monoclonal antibody, trastuzumab" in solid tumors. Pembrolizumab is a potent and highly selective humanized monoclonal antibody designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Based on strong rationale in exploring the impact of combining trastuzumab with anti-PD-1 inhibitor in HER2 positive cancer, we suggest multicenter phase IB/II study to determine antitumor activity and safety of pembrolizumab in combination with standard treatment (trastuzumab, capecitabine, and cisplatin) in patients with HER2 positive gastric cancer.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: Pembrolizumab
    200mg, IV, q3weeks, Day 1
  • Drug: Trastuzumab
    6mg/kg (8mg loading dose), IV, q3weeks, Day 1
  • Drug: Capecitabine
    1000mg/m2, PO, BID, Day 1-14
  • Drug: Cisplatin
    80mg/m2 (level 1), IV, q3weeks, Day 1
Study Arms  ICMJE Experimental: 4 combination
pembrolizumab 200mg, IV, q3weeks, Day 1 trastuzumab 6mg/kg (8mg loading dose), IV, q3weeks, Day 1 capecitabine 1000mg/m2, PO, BID, Day 1-14 cisplatin 80mg/m2 (level 1), IV, q3weeks, Day 1
Interventions:
  • Drug: Pembrolizumab
  • Drug: Trastuzumab
  • Drug: Capecitabine
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
44
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
49
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. HER2 positive advanced gastric cancer
  2. Be willing and able to provide written informed consent/assent for the trial.
  3. Be 19 years of age on day of signing informed consent.
  4. Have measurable disease based on RECIST 1.1.
  5. performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
  6. Demonstrate adequate organ function
  7. Female subject of childbearing potential should have a negative urine or serum pregnancy or be willing to use birth control.

Exclusion Criteria:

  1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  3. Has a known history of active Bacillus Tuberculosis
  4. Hypersensitivity to pembrolizumab or any of its excipients.
  5. Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier.
  6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
  7. Has a known additional malignancy that is progressing or requires active treatment within 3 years.
  8. Has known active central nervous system metastases and/or carcinomatous meningitis.
  9. Has active autoimmune disease that has required systemic treatment in the past 2 years
  10. Has known history of, or any evidence of active, non-infectious pneumonitis.
  11. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  12. Has known active Hepatitis B or Hepatitis C
  13. Has received a live vaccine within 30 days of planned start of study therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02901301
Other Study ID Numbers  ICMJE 4-2016-0190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hyun Cheol Chung, Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP