Is NCT06469944 recruiting in Louisville, KY?

Yes, NCT06469944 is currently recruiting participants at its Louisville, KY location. This gastroesophageal adenocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Louisville 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.

Gastroesophageal Adenocarcinoma Clinical Trial in Louisville, KY

Q: How do I join the gastroesophageal adenocarcinoma clinical trial in Louisville?

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

About This Gastroesophageal Adenocarcinoma Study in Louisville

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of sacituzumab tirumotecan with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase.

Sponsor: Merck Sharp & Dohme LLC

Who Can Participate

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma

Is not expected to require tumor resection during the treatment course

Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines

Core/excisional biopsy of a tumor lesion not previously irradiated has been provided

Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline

Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible

Has adequate organ function

Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR)

Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention

Has a life expectancy of at least 6 months

Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization

Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

Has squamous cell or undifferentiated gastroesophageal cancer.

Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma

Has experienced weight loss \>20% over 3 months before the first dose of study intervention

Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing

Has Grade ≥2 peripheral neuropathy

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease

Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention

Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment

Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and/or Multicentric Castleman's Disease

Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents

Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and/or a topoisomerase I inhibitor-based chemotherapy

Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention

Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)

Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids

Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued

Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration

Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention

Has known additional malignancy that is progressing or has required active treatment within the past 3 years

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients

Has active autoimmune disease that has required systemic treatment in the past 2 years

Has history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening

Has an active infection requiring systemic therapy

Has concurrent active hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus \[HCV\] Ab positive and detectable HCV ribonucleic acid \[RNA\] infection or a known history of hepatitis B and/or C infection

Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study

Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication

Has poorly controlled diarrhea

Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention

Has history of allogeneic tissue/solid organ transplant

Has not adequately recovered from major surgery or has ongoing surgical complications

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 Louisville?

Yes, this clinical trial (NCT06469944) has an active research site in Louisville, KY 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.

Gastroesophageal Adenocarcinoma Treatment Options in Louisville, KY

If you're searching for gastroesophageal adenocarcinoma treatment options in Louisville, KY, this clinical trial (NCT06469944) 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 Louisville research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced gastroesophageal adenocarcinoma 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 gastroesophageal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Gastroesophageal Adenocarcinoma Clinical Trial in Louisville, KY

Expert Care in Louisville

IRB Approved

No-Cost Care

Apply for This Louisville Location

Why Participate?

Simple Process