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Gastric CancerPhase 2NCT04249739

Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive

A Phase 2 study testing Pembrolizumab in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is an open-label, single arm, phase II trial the efficacy and safety of pembrolizumab + CapeOx (HER2 negative ARM) or pembrolizumab + Trastuzumab + Capecitabine/Cisplatin (HER2 positive ARM) as first line therapy in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteSouth Korea
Study dates
29 Sep 2020to Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent for Biomedical Research. However, the subject may participate in the main trial without participating in Biomedical Research.
  • Be 19 years of age on day of signing informed consent (or acceptable age according to local regulations, whichever is older).
  • Have histologically or cytologically-confirmed diagnosis of gastric or GEJ adenocarcinoma. (EBV positive GC and MSI-H GC will be excluded from this study). The patients must have EBV negative and MSS (or MMR-proficient) GC to enter this study.For cohort B, GC patients with HER2 + will be enrolled.
  • Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH), as assessed by central review on primary or metastatic tumor. ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for CEP17. If the ratio is <2.0 but the HER2 gene copy number is >6 the participant may be considered ISH-positive.
  • Have metastatic disease or locally advanced, unresectable disease.
  • Have measurable disease based on RECIST 1.1. as determined by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
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  • Newly obtained fresh biopsy is required before enrollment (stomach biopsy required but if stomach cancer is not intact due to previous surgery, metastatic lesion biopsy can substitute)
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • 111.Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication . Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • 12.Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Who cannot join

  • 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.
  • 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 the first dose of study drug.
  • squamous cell or undifferentiated gastric cancer.
  • Has pre-existing peripheral neuropathy >Grade 1.
  • Is a WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has active TB (Bacillus Tuberculosis)
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  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Has a known sensitivity to any component of oxaliplatin or xeloda
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
  • Has an active infection requiring systemic therapy.
  • Has had an allogenic tissue/solid organ transplant.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has received prior therapy with an anti-HER2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live vaccine within 30 days of planned start of study therapy.
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
  • Participants with ascites if it needs draining within 2 weeks or diuretic within 2 weeks of consenting this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 99999

Other trials in South Korea

About this study

Official title: Phase II Study of Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx)(HER2 Negative ARM) or Pembrolizumab + Trastuzumab+ Capecitabine／Cisplatin (HER2 Positive ARM) in Metastatic GC as First-line Treatment

This study is an open-label, single arm, phase II trial the efficacy and safety of pembrolizumab + CapeOx (HER2 negative ARM) or pembrolizumab + Trastuzumab + Capecitabine/Cisplatin (HER2 positive ARM) as first line therapy in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Read the detailed description

Cohort A is allocated for the patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who confirmed with HER2 negative, and approximately 78 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab + Capecitabine/oxaliplatin.

Cohort B is allocated for the patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who confirmed with HER2 positive, and approximately 15 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab + Trastuzumab + Capecitabine/Cisplatin

(1 Cycle: Day 1 through Day 21)

Planned Biopsy Analysis immediate pre-treatment biopsy before chemotherapy; Newly-obtained specimens are defined as FFPE-preserved blocks or fresh tissue collected up to 12 weeks prior to C1D1.

2.on treatment primary tumor biopsy (C2D1 - 3 days window; before administration of C2D1) to explore whether tumor has change in characters (i.e., immune desert to immune infiltration) 3.on treatment primary tumor biopsy (C7D1 - 3 days window; before administration of C7D1) to explore whether tumor has change in characters (i.e., immune desert to immune infiltration) 4.At progression biopsy will be optional whenever the tumor biopsy is feasible.

Conditions
Gastric Cancer
Being tested
Pembrolizumab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda, MK3475

    Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Keytruda ™ (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Study groups in NCT04249739
Study groupRoleWhat they receive
CapeOx+Pembrolizumab(HER2 negative)Experimental<Cohort A>: HER2 negative patients CapeOx+Pembrolizumab therapy (N=78) * Cycle 1 CapeOX * Cycle 2 up to Cycle 8 CapeOX + pembrolizumab therapy * Cycle 9 up to Cycle 35 Capecitabine + pembrolizumab therapy * CapeOx + Pembrolizumab administered until disease progression, unacceptable toxicity or patient's refusal. 1. Cycle: Day 1 through Day 21)
Receives: Drug: Pembrolizumab
Cape/Cis+Trastuzumab+Pembrolizumab (HER2 positive )ExperimentalCape/Cis+Trastuzumab+Pembrolizumab therapy (N=15) * Cycle 1 Capecitabine + cisplatin (Cape/Cis) * Cycle 2 up to Cycle 8 Cape/Cis + Trastuzumab + pembrolizumab therapy * Cycle 9 up to Cycle 35 Capecitabine + Trastuzumab + pembrolizumab therapy * Cape/Cis + Trastuzumab + Pembrolizumab administered until disease progression, unacceptable toxicity or patient's refusal. 1. Cycle: Day 1 through Day 21)
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR (objective response rate) per RECIST 1.1

    Git is recommended that the subject bediscontinued from the study treatment unless, in the Investigator's opinion, the subject is deriving benefit from treatment.

    Measured: 24months

Secondary outcomes (1)

  1. Genomic analysis

    Whole Exome Sequencing at baseline, RNA-seq pre and post

    Measured: 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start29 Sep 2020
  3. Primary completion6 Feb 2024
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Assigned to 1 group according to the result of HER2. \<Cohort A\>: HER2 negative patients CapeOx+Pembrolizumab therapy (N=78) * Cycle 1 CapeOX * Cycle 2 up to Cycle 8 CapeOX + pembrolizumab therapy * Cycle 9 up to Cycle 35 Capecitabine + pembrolizumab therapy * CapeOx + Pembrolizumab administered until disease progression, unacceptable toxicity or patient's refusal. 1. Cycle: Day 1 through Day 21) \<Cohort B\>: HER2 positive patients Cape/Cis+Trastuzumab+Pembrolizumab therapy (N=15) * Cycle 1 Capecitabine + cisplatin (Cape/Cis) * Cycle 2 up to Cycle 8 Cape/Cis + Trastuzumab + pembrolizumab therapy * Cycle 9 up to Cycle 35 Capecitabine + Trastuzumab + pembrolizumab therapy * Cape/Cis + Trastuzumab + Pembrolizumab administered until disease progression, unacceptable toxicity or patient's refusal. 1. Cycle: Day 1 through Day 21)
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04249739
Sponsor's protocol ID
2019-11-089
Status last verified
Mar 2024
First submitted
21 Jan 2020
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lim SH, Kuwata T, An M, Hong JY, Kim ST, Matsubara Y, Shitara K, Lee J. Dynamic modulation of claudin18.2 expression and remodeling of the tumor microenvironment in gastric cancer during chemo-immunotherapy. J Immunother Cancer. 2025 Sep 29;13(9):e012683. doi: 10.1136/jitc-2025-012683.

    PubMed 41027671

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (objective response rate) per RECIST 1.1 (time frame: 24months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04249739, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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