TAK-500 + Pembrolizumab for Advanced Solid Cancers
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called TAK-500, alone or with pembrolizumab, in adults with advanced or spreading solid tumors. The goal is to see if TAK-500 is safe and effective in shrinking these tumors.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had certain treatments like other STING agonists/antagonists, Toll-like receptor agonists, or CCR2 agonists/antagonists within the past 6 months. Also, you must not have received any investigational products or anticancer therapy within 14 days or 5 half-lives before starting the study drug. It's best to discuss your current medications with the study doctor.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain treatments like other investigational products or anticancer therapies within 14 days before starting the study drugs. It's best to discuss your current medications with the study doctor to get specific guidance.
What data supports the idea that TAK-500 + Pembrolizumab for Advanced Solid Cancers is an effective drug?
The available research shows that pembrolizumab, a part of the TAK-500 + Pembrolizumab combination, has been effective in treating certain types of cancer. For example, in patients with advanced non-small cell lung cancer, pembrolizumab improved survival rates compared to traditional chemotherapy. In one study, patients who received pembrolizumab lived longer and had a longer period before their cancer got worse compared to those who received chemotherapy. Additionally, pembrolizumab has shown benefits in treating advanced melanoma, where it improved survival and response rates compared to other treatments. These results suggest that pembrolizumab, when combined with TAK-500, could be an effective option for treating advanced solid cancers.12345
What data supports the effectiveness of the drug pembrolizumab in treating advanced solid cancers?
Pembrolizumab has been shown to improve survival rates and slow disease progression in patients with advanced non-small cell lung cancer and melanoma, as demonstrated in several clinical trials. These studies indicate that pembrolizumab can be an effective treatment option for certain types of advanced cancers.12345
What safety data is available for TAK-500 and Pembrolizumab in treating advanced solid cancers?
Pembrolizumab, also known as KEYTRUDA or MK-3475, has been evaluated in various clinical trials for different cancers. Safety data from these trials indicate that common adverse reactions include fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, hypophysitis, and thyroid disorders have also been reported. Pembrolizumab has shown clinical activity in solid tumors and is approved for certain cancers, but it can cause serious side effects like pneumonitis in 1%-5% of patients. There is no specific safety data provided for TAK-500 in the provided research.25678
What safety information is available for pembrolizumab (Keytruda) in treating advanced solid cancers?
Pembrolizumab (Keytruda) has been used in various studies for different cancers, showing some common side effects like fatigue, cough, nausea, rash, and diarrhea. Serious immune-related side effects, such as lung inflammation (pneumonitis), liver inflammation (hepatitis), and thyroid problems, have also been reported, but these are less common.25678
Is the drug Pembrolizumab (also known as Keytruda or MK-3475) a promising treatment for advanced solid cancers?
Yes, Pembrolizumab is a promising drug for advanced solid cancers. It has been approved for treating various cancers, including endometrial carcinoma, non-small-cell lung cancer, melanoma, and esophageal cancer. It works by helping the immune system fight cancer cells, and studies have shown it can improve survival rates and response to treatment.245910
How is the drug TAK-500 + Pembrolizumab unique for treating advanced solid cancers?
This treatment combines TAK-500 with Pembrolizumab, a PD-1 inhibitor that helps the immune system attack cancer cells, and is unique because it targets the PD-1/PD-L1 pathway, which is a novel approach in treating various solid tumors. Pembrolizumab has shown effectiveness in other cancers like non-small cell lung cancer and esophageal cancer, suggesting potential benefits in advanced solid cancers when combined with TAK-500.245910
Research Team
Study Director
Principal Investigator
Takeda
Eligibility Criteria
Adults with certain advanced or metastatic solid tumors, including various cancers like lung, liver, breast, and stomach cancer. Participants must be in good physical condition (ECOG 0-1), have measurable disease per RECIST criteria, adequate organ function, and no severe side effects from previous treatments. They should not have heart issues or active hepatitis among other exclusions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive TAK-500 as a single agent or in combination with pembrolizumab to determine the recommended dose for expansion
Dose Expansion
Participants receive TAK-500 at the recommended dose, either alone or with pembrolizumab, to evaluate safety and antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
- TAK-500
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier