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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT04662710

NCT04662710
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with stomach or esophageal cancer (specifically adenocarcinoma) that has spread or cannot be surgically removed, and you have not yet received any treatment for it
  • Your cancer is not expected to need surgery during the treatment period
  • Your cancer has tested negative for a protein called HER-2 (confirm with trial site)
  • Your cancer can be measured using standard imaging scans with contrast dye
  • You are in good enough general health to carry out light activity, as measured by a standard health scale (ECOG score of 0 or 1), checked within 3 days before starting treatment
  • Your blood pressure is reasonably controlled, with or without blood pressure medication
  • Your organs (such as liver, kidneys, etc.) are functioning well enough to handle treatment
  • If you are male, you agree to use contraception or abstain from sex, and not donate sperm, during treatment and for a set period afterward
  • If you are female, you are not pregnant or breastfeeding, and if you could become pregnant, you agree to use reliable contraception or abstain from sex, and not donate or store eggs, during treatment and for a set period afterward

Who may not be able to join:

  • You have already received treatment for this advanced or metastatic stomach/esophageal cancer
  • You have had major surgery within the last 28 days
  • You have had radiation therapy within the last 14 days
  • You have another cancer that is active or has needed treatment within the past 5 years
  • Your cancer has spread to the brain or the lining around it
  • You have had a severe allergic reaction to a similar type of medication used in this trial, or are known to be sensitive to any of the study drugs or their ingredients
  • You have received an organ or tissue transplant from another person
  • You have a significant risk of a hole forming in your digestive tract, or you have significant bleeding in your digestive system
  • You have a blockage in your digestive system, eat very little, or have difficulty swallowing pills (particularly relevant for one part of the study)
  • You have previously been treated with certain types of immunotherapy drugs that work on the immune system's checkpoint pathways (confirm with trial site)
  • You have previously been treated with certain drugs that target blood vessel growth (anti-VEGF therapies) (confirm with trial site)
  • You have received a live vaccine within 30 days before starting the trial
  • You have an active autoimmune disease that has needed systemic treatment in the past 2 years (e.g., with steroids or immune-suppressing drugs)
  • Scans show your cancer is wrapping around or growing into a major blood vessel, or there are hollow spaces forming within the tumor
  • You have a heart condition that is not well controlled (confirm with trial site)
  • You have a history of, or currently have, a lung inflammation condition (pneumonitis or interstitial lung disease) that required steroid treatment
  • You have diarrhea that is difficult to control
  • You have had fluid build-up around your lungs, abdomen, or heart that needed draining or water tablets within the last 2 weeks
  • You have significant nerve damage in your hands or feet (peripheral neuropathy, grade 2 or above) (confirm with trial site)
  • You have a known history of HIV
  • You have a known history of active Hepatitis B or Hepatitis C infection
  • You have lost more than 20% of your body weight in the last 3 months

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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Registry
clinicaltrials_gov
Start date
30 December 2020
Est. completion
29 October 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia Costa Rica 🇫🇷 France 🇩🇪 Germany Guatemala Hong Kong 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs); Part 1: Number of Participants With Adverse Events (AEs); Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE; Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1; Part 2: OS in All Participants; Part 2: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1; Part 2: PFS Per RECIST 1.1 as Ass...

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov