Is NCT06123338 recruiting in Middletown, NJ?

Yes, NCT06123338 is currently recruiting participants at its Middletown, NJ location. This esophageal cancer clinical trial is actively enrolling qualified participants.

How do I join the esophageal cancer clinical trial in Middletown?

To join this clinical trial in Middletown, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Middletown clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Esophageal Cancer Clinical Trial in Middletown, NJ

Who Can Participate

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:

Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Middletown?

Yes, this clinical trial (NCT06123338) has an active research site in Middletown, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Esophageal Cancer Treatment Options in Middletown, NJ

If you're searching for esophageal cancer treatment options in Middletown, NJ, this clinical trial (NCT06123338) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Middletown research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced esophageal cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all esophageal cancer clinical trials near you to find additional studies recruiting in your area.

Esophageal Cancer Clinical Trial in Middletown, NJ

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About This Esophageal Cancer Study in Middletown