Phase 2 Oesophageal Cancer Trial, Recruiting NCT06469944 Sponsor: Merck Sharp & Dohme LLC Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT06469944
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a confirmed diagnosis (through biopsy or lab testing) of locally advanced, inoperable, or metastatic stomach or esophageal adenocarcinoma (a specific type of cancer) that has not yet been treated
  • People whose cancer is not expected to need surgical removal during the course of the study
  • People whose tumor has tested negative for a protein called HER2, based on established medical guidelines
  • People who have provided a tissue sample (core or excisional biopsy) from a tumor area that has not previously been treated with radiation
  • People whose side effects from any previous cancer treatments have mostly resolved to a mild or baseline level
  • People with hormone-related side effects from prior treatment that are being well managed with hormone replacement therapy
  • People whose organs (such as liver and kidneys) are functioning adequately, as determined by the trial site
  • People whose cancer can be measured on scans according to a standard set of criteria (RECIST 1.1), confirmed by both local and independent reviewers
  • People with a general health and activity level rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work), assessed within 3 days before starting treatment
  • People who are expected to live for at least 6 months
  • People who have hepatitis B, provided they have been on antiviral treatment for at least 4 weeks and have an undetectable hepatitis B virus level before being enrolled
  • People with a history of hepatitis C, provided the hepatitis C virus is undetectable at the time of screening
  • People living with HIV, provided their HIV is well controlled on antiretroviral medication

Who may not be able to join:

  • People whose stomach or esophageal cancer is of the squamous cell or undifferentiated type (rather than adenocarcinoma)
  • People who have already received treatment for locally advanced, inoperable, or metastatic stomach, gastroesophageal junction, or esophageal adenocarcinoma
  • People who have lost more than 20% of their body weight in the 3 months before starting the study
  • People with a history of severe dry eye disease, severe eyelid gland disease, or severe corneal conditions that affect healing
  • People with moderate or severe nerve damage causing numbness, tingling, or weakness (Grade 2 or higher peripheral neuropathy)
  • People with active inflammatory bowel disease currently requiring immune-suppressing medication, or with a history of this condition
  • People who have had a significant heart or blood vessel condition within the 6 months before the study
  • People who have had a build-up of fluid around the lungs, abdomen, or heart requiring drainage or water tablets within 2 weeks before enrolling
  • People living with HIV who have also had Kaposi's sarcoma or a condition called Multicentric Castleman's Disease
  • People who have previously been treated with therapies targeting a protein called TROP2 or HER3
  • People who have previously received a type of chemotherapy drug called a topoisomerase I inhibitor, whether given alone or as part of an antibody-drug combination
  • People who have received any systemic cancer treatment within 4 weeks before starting the study
  • People who have previously been treated with immune checkpoint therapy targeting PD-1, PD-L1, PD-L2, or similar immune system pathways
  • People who have had radiation therapy within 2 weeks before starting the study, or who still have radiation-related side effects requiring steroid treatment
  • People who have received a live vaccine within 30 days before starting the study
  • People who are taking certain strong medications that significantly affect how the body processes other drugs (strong CYP3A4 inducers or inhibitors) and cannot stop taking them
  • People who have taken part in another clinical trial or used an experimental device within 4 weeks before starting the study
  • People with a known immune system deficiency, or who have been on ongoing steroid or immune-suppressing treatment within 7 days before starting the study
  • People with another cancer that is still active or has required treatment within the past 3 years
  • People with known active cancer spread to the brain or the lining of the brain
  • People with a history of severe allergic reactions (Grade 3 or higher) to any of the study drugs or their ingredients, including pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, oxaliplatin, fluorouracil, capecitabine, leucovorin, or levoleucovorin
  • People with an autoimmune disease that has needed systemic medical treatment within the past 2 years
  • People with a history of lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition, or where this condition cannot be ruled out on scans at screening
  • People with an active infection that requires treatment with systemic medication
  • People who have both active hepatitis B and hepatitis C at the same time, or a known history of both infections
  • People with any other condition, treatment, or circumstance that the trial site determines could interfere with the study results or with the person's ability to participate
  • People with a blockage in the digestive tract, difficulty eating, or trouble swallowing oral medications
  • People with poorly controlled diarrhoea
  • People who have had major surgery or a serious injury within 4 weeks before starting the study
  • People who have had a transplant of an organ or tissue from another person
  • People who have not yet fully recovered from major surgery or who still have complications from surgery

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
20 September 2024
Est. completion
12 September 2029

Where this trial is recruiting

🇧🇷 Brazil 🇨🇱 Chile 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇴 Norway 🇰🇷 South Korea 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand 🇺🇸 United States

Primary endpoints

Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs); Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE); Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE; Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov