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Lenvatinib & Pembrolizumab for Gastroesophageal Cancer
Study Summary
This trial is testing a new combination therapy for metastatic gastroesophageal cancer in patients who have progressed on other treatments. The hope is that this new combination will provide better outcomes than existing treatments.
- Gastroesophageal Cancer
- Stomach Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a history of or currently have a lung condition called pneumonitis that is not caused by an infection.You have already been treated with a type of medication called anti-PD-1, anti-PD-L1, or anti-PD-L2.You have a condition that affects the way your body absorbs lenvatinib or other nutrients from your food.You have a bleeding disorder or have had significant bleeding within the past 3 weeks.You have a heart condition that requires certain medications to control abnormal heart rhythms or severe slowing of the heart.You are allergic to pembrolizumab or lenvatinib or any of the ingredients in these medications.You have had a hole or tear in your digestive system in the past.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer or early-stage cervical cancer.You have cancer that has spread to your brain or the protective lining of your brain. If you have had previous treatment for brain metastases and they are not growing or causing symptoms, you may still be eligible to participate. However, you must stop taking steroids for at least a week before starting the trial treatment.
- Group 1: Lenvatinib & Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this scientific investigation accept applicants of twenty or more years?
"This clinical trial is limited to individuals aged 18 or older and under the age of 100."
What additional evidence has been gathered in regards to this medical intervention?
"Currently, 1032 studies are being conducted to investigate this medical intervention. Out of those trials, 134 have reached the third stage of testing and they mainly occur in Sacramento, California; however, there are 37061 sites running these experiments worldwide."
Could you elucidate on the security of this therapeutic approach?
"Previous clinical trials have provided an adequate level of safety evidence, so the treatment was assigned a score of 2. As this is only a Phase 2 trial, there are currently no data that confirm its efficacy."
Who is eligible to participate in this research study?
"Eligible candidates for this investigation must be 18-100 years old, and have a diagnosis of stomach cancer. Currently 24 individuals are required to partake in the trial."
In what circumstances is this remedy typically recommended?
"This treatment has proven to be effective at managing malignant neoplasms, unresectable melanoma, and microsatellite instability high cases."
Is the recruitment of participants for this study ongoing?
"Clinicaltrials.gov's records denote that this research is currently attempting to recruit participants, with the first posting having occurred on October 24th 2017 and an update being made as recently as August 12th 2022."
To what extent is the participant pool expanding for this trial?
"Affirmative. Clinicaltrials.gov hosts records that indicate this clinical trial is currently searching for participants, which was first noted on October 24th 2017 and revised August 12th 2022. The study requires the recruitment of twenty-four patients from three different medical centres."
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