AzTrials
AzTrials

Recurrent/Advanced Gastric CancerPhase 2NCT05512182

Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression

A Phase 2 study testing Chemotherapy in people with Recurrent/Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Clinical Indication : HER mutated or HER2 Amplification/Overexpression in Gastric Cancer, 2nd-line Trial Type : Interventional, Open label Treatment Groups : Single arm: Pembrolizumab 200 mg every 3 weeks (Q3W), neratinib at 240 mg once daily (QD), and paclitaxel 175 mg/m2 every 3 weeks (Q3W) Number of trial… Read more about this study

Who is it for?
Ages 19 to 99 years
Conditions the study is for
Recurrent/Advanced Gastric Cancer
What is being tested?
Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSouth Korea
Study dates
15 Sep 2022to 30 Oct 2023
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has provided written informed consent for the trial.
  • Is male or female at least 19 years of age on the day of signing informed consent.
  • Has a histologically or cytologically confirmed diagnosis of advanced or metastatic gastric adenocarcinoma (systemic metastasis or locally advanced unresectable gastric cancer). A subject must have previously received 1st line chemotherapy using fluoropyrimidine- or platinum-based regimen and showed progression.
  • Has tumors with known activating EGFR, ERBB2, ERBB3, ERBB4 mutations or HER2 amplification by NGS, or HER2 overexpression by IHC or SISH/FISH
  • Has a life expectancy of at least 3 months.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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  • Have measurable or evaluable disease determined by RECIST 1.1.
  • Is able to swallow and retain orally administered medication.
  • Have adequate organ function as defined in the following table:
  • white blood cells ≥3000/mm3 and neutrophils ≥1000/mm3
  • platelets ≥100 000/µL
  • hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
  • AST (SGOT) and ALT (SGPT) ≤3.0 × upper limit of normal (ULN) of the study site (or ≤5.0 × ULN in patients with liver metastases)
  • total bilirubin ≤2.0 × ULN
  • creatinine ≤1.5 × ULN or creatinine clearance >60 mL/min (either measured value or estimated value using the Cockcroft-Gault equation)
  • Has failed in trastuzumab treatment for HER2-positive patients during 1st-line treatment or trastuzumab-naïve for HER2-negative patients measured by IHC or SISH/FISH.
  • Has left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).
  • A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3; OR
  • A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 6 months after the last dose of study treatment.

Who cannot join

  • Have received second line or more of anticancer treatment (not including adjuvant chemotherapy).
  • Have multiple cancers (with the exception of completely resected basal cell carcinoma, thyroid cancer, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer, and any other cancers that have not recurred for at least 5 years).
  • Have history of hypersensitivity to anti-HER2, immune-oncology drugs.
  • Have brain or leptomeningeal metastases. Patients may be enrolled for the study if they are asymptomatic and require no treatment.
  • Have a tumor with an activating KRAS co-mutation.
  • Have a history of uncontrollable or significant cardiovascular disease meeting any of the following:
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  • myocardial infarction within 180 days before study enrolment
  • uncontrollable angina pectoris within 180 days before study enrollment
  • New York Heart Association (NYHA) Class III or IV congestive heart failure
  • uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg lasting 24 hours or more) arrhythmia requiring treatment.
  • Have active, unresolved systemic infection requiring treatment.
  • Are contraindicated for pembrolizumab, neratinib, or paclitaxel, or have severe hypersensitivity (≥Grade 3) to any of those drugs and/or their excipients.
  • 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Have undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment.
  • Have received radiotherapy for gastric cancer within 14 days before study treatment.
  • Have received systemic chemotherapy within 14 days before study treatment.
  • Have received biologic therapy ≤2 weeks or 5 half-lives (t1/2) of the agent used, whichever is shorter, prior to the start of treatment.
  • Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody.
  • Have hepatitis B surface protein (HBs) antigen and HBV titer >2000 IU/ml (10,000 copy/ml), or hepatitis C virus (HCV) antibody positive result.
  • Are pregnant or breastfeeding, or possibly pregnant.
  • Have any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from previous anti-cancer therapy at the time of enrollment such as neuropathy, except for alopecia.
  • Are incapable of providing consent for specific reasons, such as concurrent dementia or unwilling for any reason to give consent or to comply with procedures/requirements of this protocol.
  • Are otherwise inappropriate for this study in the investigator's or sub-investigator's opinion.
  • Demonstrates a QTc interval >450 ms for men or >470 ms for women, or has known history of congenital QT-prolongation or Torsade de pointes (TdP).
  • Have significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or ≥Grade 2 diarrhea [per CTCAE v5.0] of any etiology at baseline).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: An Open Label, Single-Arm, Multi-Center Phase II Study to Evaluate the Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression

Clinical Indication : HER mutated or HER2 Amplification/Overexpression in Gastric Cancer, 2nd-line Trial Type : Interventional, Open label Treatment Groups : Single arm: Pembrolizumab 200 mg every 3 weeks (Q3W), neratinib at 240 mg once daily (QD), and paclitaxel 175 mg/m2 every 3 weeks (Q3W) Number of trial participants : Approximately 68 patients will be enrolled (with 10% drop-out).

Estimated enrollment period : 24 months Estimated duration of trial : It is estimated that the trial will require approximately 30 months from the time the first patient signs the informed consent until the last patient's last visit.

  • First Patient In: Mar 2021
  • Last Patient In: Feb 2023
  • Last Patient Last Visit: Aug 2023 Duration of Participation : 30 months
Being tested
Chemotherapy
Medical subject headings
Recurrence

What participants receive

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

  • ChemotherapyDrug

    Pembrolizumab : 200mg/Q3W/IV infusion/Day 1of each 3-week cycle Neratinib : Week 1: 120 mg, Week 2: 160 mg, Week 3 and onwards: 240 mg/QD/Oral/Once daily Paclitaxel : 175mg/m2 /Q3W/IV infusion/Day 1of each 3-week cycle

Study groups in NCT05512182
Study groupRoleWhat they receive
ChemotherapyExperimentalNot described
Receives: Drug: Chemotherapy

What is being measured

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

  1. objective response rate (ORR)

    • To determine the objective response rate (ORR) as a second line treatment in recurrent/advanced gastric cancer with somatic HER2 mutations with or without HER2 amplification/overexpression.

    Measured: 2 years

Secondary outcomes (5)

  1. overall survival (OS)

    overall survival (OS).

    Measured: 2 years

  2. progression-free survival (PFS)

    according to RECIST 1.1.

    Measured: 2 years

  3. disease control rate (DCR)

    according to RECIST 1.1.

    Measured: 2 years

  4. duration of response (DoR)

    duration of response (DoR) according to RECIST 1.1.

    Measured: 2 years

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0

    • To evaluate the safety of pembrolizumab in combination with neratinib and paclitaxel.

    Measured: 2 years

Timeline

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

  1. First posted23 Aug 2022
  2. Study start15 Sep 2022 (estimated)
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

Why it stopped: No participants enrolled

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05512182
Sponsor's protocol ID
4-2021-1119
Status last verified
Jun 2023
First submitted
10 Aug 2022
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy in people with Recurrent/Advanced Gastric Cancer, run by Yonsei University 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 21 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: withdrawn, as of the sponsor's last update on 15 Jun 2023. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

objective response rate (ORR) (time frame: 2 years). 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 NCT05512182.

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 15 Jun 2023.

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