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Esophagogastric TumorsPhase 2NCT04510285

A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

A Phase 2 study testing Trastuzumab and Pembrolizumab in people with Esophagogastric Tumors and Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to find out whether treatment with trastuzumab combined with pembrolizumab will improve the clearance of tumor DNA from participants' bodies after surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
7 sitesUnited States
Study dates
10 Aug 2020to 30 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Age 18 years or older.
  • ECOG performance status 0-2.
  • Sign informed consent within 8 months after curative surgery and completion of standard of care perioperative and/or adjuvant therapy.
  • HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH>2.0 expression.
  • Must have genetic testing of DNA from primary tumor for somatic genomic alterations across a minimum of 50 genes.
  • Must have undergone a complete curative surgical resection (R0).
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  • Must have completed standard of care (SOC) surgery, neoadjuvant or adjuvant therapy
  • CtDNA will be tested at a minimum of four weeks after completion of surgery and standard perioperative and/or adjuvant therapy. To be eligible for trastuzumab/pembrolizumab or trastuzumab therapy, the patients must have positive ctDNA (as defined in section 7.0) within 8 months after completion of appropriate standard of care therapy (surgery, chemotherapy, radiation as appropriate). For all patients, if the initial ctDNA has a negative result, ctDNA can be re-tested 4 weeks later, within 9 months of completion of standard therapy.
  • Demonstrate adequate organ function as defined in Table 1.
  • Hematological Absolute neutrophil Count (ANC): ≥ 1,500 /mcL Platelets: ≥ 100,000 /mcL Hemoglobin: ≥ 9 g/dL
  • Renal Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
  • Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. Except patients with Gilbert's disease (≤ 3 x ULN) AST and ALT ≤ 2.5 X ULN Albumin ≥ 3 mg/dL

Who cannot join

  • Patients who have not recovered from serious adverse events (as determined by treating MD) related to surgery.
  • Presence of metastatic or recurrent disease.
  • Had R1 (microscopic residual tumor) or R2 resection (macroscopic residual tumor at resection margin).
  • Left ventricular ejection fraction <50% within 1 month of screening by MUGA or echocardiogram.
  • 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 systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
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  • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
  • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  • Has a known history of active TB (Bacillus tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • 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.
  • ° Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • 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-CTLA-4 agent.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
  • Subjects with vitiligo or alopecia
  • Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.
  • 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.
  • ° Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Is unwilling to give written informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

The purpose of this study is to find out whether treatment with trastuzumab combined with pembrolizumab will improve the clearance of tumor DNA from participants' bodies after surgery.

Keywords
Esophagogastric Tumors, Esophagogastric Cancers, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction Cancer, GEJ Tumor, Pembrolizumab, Trastuzumab, 20-158, Memorial Sloan Kettering Cancer Center
Medical subject headings
Stomach Neoplasms, Esophageal Neoplasms

What participants receive

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

  • TrastuzumabDrug

    Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days).

  • PembrolizumabDrug

    Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).

Study groups in NCT04510285
Study groupRoleWhat they receive
Trastuzumab and PembrolizumabExperimentalTrastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks.
Receives: Drug: Trastuzumab; Drug: Pembrolizumab

What is being measured

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

  1. Rate of ctDNA Clearance at 6 Months

    The primary endpoint of the study is the proportion of patients with ctDNA clearance at 6 months with trastuzumab/pembrolizumab or trastuzumab/placebo in patients with HER2+ esophagogastric cancer with persistent ctDNA despite curative surgery and standard perioperative/adjuvant therapy.

    CtDNA clearance is the conversion of detectable to undetectable ctDNA

    Measured: 6 months

Timeline

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

  1. First posted12 Aug 2020
  2. Study start10 Aug 2020
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Why it stopped: Lack of accrual

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
Model description
This is a single arm pilot study of adjuvant pembrolizumab + trastuzumab.
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510285
Sponsor's protocol ID
20-158
Status last verified
Jan 2023
First submitted
10 Aug 2020
Last updated
1 Feb 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab and Pembrolizumab in people with Esophagogastric Tumors and Gastric Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

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 27 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: stopped early, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of ctDNA Clearance at 6 Months (time frame: 6 months). 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 NCT04510285.

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 1 Feb 2023.

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