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TAK-500 + Pembrolizumab for Advanced Solid Cancers
Study Summary
This trial is studying TAK-500 to find out how well it works in treating adults with certain types of solid tumors that have spread or cannot be removed by surgery. TAK-500 will be given alone or with pembrolizumab and will be compared to standard of care.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have ongoing hepatitis B or C.I haven't taken any experimental or cancer treatments in the last 14 days or 5 half-lives, whichever is shorter.I have received a stem cell or organ transplant.I have had episodes of brain confusion due to liver problems.I have had or have serious fluid buildup in my abdomen needing drainage.I haven't had radiation therapy in the last 14 days (or 42 days for lung radiation) or radionuclide treatment in the last 42 days.My liver function is relatively good (Child-Pugh A or B7).I haven't taken steroids or immunosuppressants in the last 14 days.I am using corticosteroids that are not taken by mouth or injection.I am on a low dose of steroids, not more than 10 mg of prednisone daily.I cannot take pembrolizumab or similar drugs due to previous bad reactions or other reasons.My cancer has worsened or I can't tolerate standard treatments.My blood, kidney, and liver tests are within normal ranges.My liver function tests are within the required range.My heart pumps well, with an ejection fraction over 50%.My side effects from previous treatments have mostly gone away, except for hair loss, mild nerve pain, or hormone issues treated with medication.I haven't had serious heart or stroke issues in the last 6 months.I have had low blood pressure that needed treatment.I do not have severe lung conditions or uncontrolled fluid in my lungs.My blood counts meet the required levels for treatment.I haven't had certain cancer antibody treatments in the last 4 weeks.I am allergic to components in the study drugs, including L-histidine, polysorbate 80, or sucrose.I haven't taken STING, Toll-like receptor, or CCR2 drugs in the last 6 months.I have a high fever caused by cancer.I can carry out all my daily activities without help.My kidneys are functioning well enough, based on a specific test.You have been using e-cigarettes or vaping within the past 90 days before starting the study drug.You are currently a smoker.
- Group 1: Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 + Pembrolizumab (RDE 1)
- Group 2: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 1)
- Group 3: Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SA
- Group 4: Dose Escalation: TAK-500 Single Agent (SA)
- Group 5: Dose Escalation: TAK-500 + Pembrolizumab
- Group 6: Dose Expansion: 3L RCC: TAK-500 + Pembrolizumab (RDE 1)
- Group 7: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 2)
- Group 8: Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SA
- Group 9: Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SA
- 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
How secure is the application of TAK-500 for human health?
"Due to the limited safety and efficacy data surrounding TAK-500, it received a score of 1."
In what geographic locations is this trial carrying out its research?
"Besides the University of Colorado - Anschutz Medical Campus - PPDS in Aurora, Dana Farber Cancer Institute in Boston, and Cancer Clinical Trials Office (CCTO) University of Colorado Anschutz Medical Campus in Denver, this trial is also recruiting patients from 8 other medical centres."
Is there still the opportunity to join this clinical exploration?
"According to clinicaltrials.gov, this medical trial is actively seeking participants after first being posted on April 26th 2022 and most recently updated on August 3rd of the same year."
For what medical conditions is TAK-500 commonly employed?
"TAK-500 is frequently utilized to treat malignancies. It can also be beneficial in the management of unresectable melanoma, microsatellite instability high, and as a response to chemotherapy failure."
How extensive is the scope of participants in this particular research study?
"In order to proceed with the clinical trial, a total of 106 qualified participants are required. The sponsor for this study, Takeda Pharmaceuticals, is recruiting patients from two sites - University of Colorado - Anschutz Medical Campus- PPDS in Aurora and Dana Farber Cancer Institute in Boston."
What other exploratory trials have been conducted with TAK-500?
"At the moment, there are 961 clinical trials for TAK-500. Of those active studies, 122 have progressed to Phase 3. Many of these experiments take place in Houston, Texas; however, it should be noted that 35731 sites around the world offer this medication as part of a research study."
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