NCT04510285

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1 month until next milestone

Results Posted

Study results publicly available

February 1, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

August 10, 2020

Results QC Date

January 5, 2023

Last Update Submit

January 5, 2023

Conditions

Esophagogastric TumorsGastric CancerGastric TumorEsophageal CancerEsophageal NeoplasmsEsophageal TumorGastroEsophageal CancerGastroesophageal Junction AdenocarcinomaGastroesophageal Junction TumorGastroesophageal Junction Cancer

Keywords

Esophagogastric TumorsEsophagogastric CancersGastric CancerEsophageal CancerGastroesophageal Junction CancerGEJ TumorPembrolizumabTrastuzumab20-158Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (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

    6 months

Study Arms (1)

Trastuzumab and Pembrolizumab

EXPERIMENTAL

Trastuzumab 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.

Drug: TrastuzumabDrug: Pembrolizumab

Interventions

TrastuzumabDRUG

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

Trastuzumab and Pembrolizumab
PembrolizumabDRUG

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

Trastuzumab and Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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.
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Interventions

Trastuzumabpembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Yelena Janjigian,MD
Organization
Memorial Sloan Kettering Cancer Center
janjigiy@mskcc.org
646-888-4186

Study Officials

  • Yelena Y Janjigian, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single arm pilot study of adjuvant pembrolizumab + trastuzumab.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 12, 2020

Study Start

August 10, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 1, 2023

Results First Posted

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)