Trial Title:
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
NCT ID:
NCT06123338
Condition:
Esophageal Cancer
Gastric Adenocarcinoma
HER2 Gene Mutation
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Pembrolizumab
Trastuzumab
Capecitabine
Oxaliplatin
Conditions: Keywords:
HER2+ Esophageal cancer
Esophageal Cancer
Gastric Adenocarcinoma
HER2+ GEJ cancer
HER2 IHC3+ expression
IHC 2+/FISH>2.0 expression
Esophagogastric cancer
Memorial Sloan Kettering Cancer Center
23-124
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab will be administered on an every 3-week dosing schedule
Arm group label:
Participants with Esophagogastric Cancer
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Trastuzumab will be administered on an every 3-week dosing schedule
Arm group label:
Participants with Esophagogastric Cancer
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin every 3 weeks, +/-7 days
Arm group label:
Participants with Esophagogastric Cancer
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3
weeks
Arm group label:
Participants with Esophagogastric Cancer
Summary:
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to
standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 years or older at time of signing informed consent.
- ECOG performance status 0-1.
- HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as
defined by local HER2 IHC3+ or IHC 2+/FISH>2.0 expression.
- Complete surgical resection of the primary tumor must be achievable
- Demonstrate adequate organ function as defined in Table 1.
Table 1 - Organ Function Requirements for Eligibility Hematological
- Absolute neutrophil count (ANC): ≥1,500 /mcL
- Platelets: ≥100,000 / mcL
- Hemoglobin: ≥8 g/dL Renal
- Creatinine clearance: ≥ 50 mL/minute 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 (≤3x ULN)
- AST and ALT: ≤ 2.5 X ULN
- Albumin: >3 mg/dL Coagulation
- International normalized ratio (INR) OR prothrombin time (PT) Activated partial
thromboplastin time (aPTT): <1.5 x ULN unless participant is receiving anticoagulant
therapy as long as PT or aPTT is within therapeutic range of intended use of
anticoagulants
- Male participants: A male participant must agree to use contraception as detailed in
Section 15.3 of this protocol during the treatment period and for at least 230 days
(5 terminal half-lives of trastuzumab [140] plus an additional 90 days
[spermatogenesis cycle]) after the last dose of study treatment and refrain from
donating sperm during this period.
- Female participants: A female participant is eligible to participate if she is not
pregnant, not breastfeeding, and at least one of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR
2. A WOCBP who agrees to follow the contraceptive guidance in section 15.3 during
the treatment period and for at least 170 days (140 days plus an additional 30
days [menstruation cycle]) after the last dose of study treatment.
Exclusion Criteria:
- Presence of metastatic or recurrent disease.
- Has received prior treatment for esophagogastric cancer
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
- Has received prior therapy with an anti-HER2 agent
- Left ventricular ejection fraction <50% within 1 month of screening by MUGA or
echocardiogram. Patients with an ejection fraction 45-49% may be permissible in the
absence of any cardiac symptoms, if cleared by a cardiologist, and per the
investigator's discresion.
- 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 been diagnosed or treated for another malignancy in the past 3 years (not
including non-melanoma skin cancer)
- 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.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required.
- Has had an allogeneic tissue or solid organ transplant
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins University (Data Collection Only)
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vincent Lam, MD
Phone:
410-955-5864
Facility:
Name:
Massachusetts General Hospital (Data Collection Only)
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samuel Klempner, MD
Phone:
617-724-4000
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Y Janjigian, MD
Phone:
646-888-4186
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Janjigian, MD
Phone:
646-888-4186
Start date:
February 1, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Genentech, Inc.
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123338
http://www.mskcc.org
