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Study Summary
This trial is testing a combination of two immunotherapy drugs, TAK-676 and pembrolizumab, to see if they can improve outcomes for people with non-small cell lung cancer, triple-negative breast cancer, and squamous cell carcinoma of the head and neck.
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.Trial Design
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Who is running the clinical trial?
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- My heart pumps well, with an ejection fraction over 50%.I haven't had serious heart or stroke issues in the last 6 months.My cancer is advanced and I have a history of specific treatments with my organs working well.You have a history of severe autoimmune disorders, HIV, or other immune system problems that are not well controlled.I haven't taken any experimental drugs or cancer treatments recently.You are currently smoking cigarettes.I currently have a serious infection or a high fever due to cancer.You have used a vaping device in the 90 days before starting the study.I have ongoing, active hepatitis.I have experienced moderate to severe low blood pressure.I have not received a live vaccine in the last 28 days.I have received a stem cell or organ transplant.I haven't taken steroids or immunosuppressants recently.Your heart's electrical activity, measured on a special heart test, is too long.My selected lesions for biopsy or assessment have not been radiated recently.I have been diagnosed with a specific lung disease.I have at least 2 tumors that can be measured, with one inside and one outside the radiation area, and I agree to biopsies.I am fully active or can carry out light work.My side effects from previous treatments have mostly gone away.Your oxygen level is below 92% when you are not using extra oxygen.I haven't taken STING or toll-like receptor treatments in the last 6 months.I haven't taken drugs that affect liver transport proteins recently.
- Group 1: Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676
- 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
Are there still openings for potential study participants?
"Affirmative. Clinicaltrials.gov's details demonstrate that this study, which was initially posted on September 9th 2021, is still open to new participants. 65 individuals are anticipated at seven different clinical sites."
Are there any previous experiments conducted involving TAK-676?
"Presently, there are 961 experiments ongoing that utilize TAK-676 with 122 Phase 3 trials. Houston, TX hosts a number of these tests; however, the total count for locations running TAK-676 studies is 35731."
What potential risks have been observed with TAK-676 administration?
"There is scarce data confirming the efficacy and safety of TAK-676, thus it was assigned a score of 1."
Are there any Canadian healthcare facilities participating in this research?
"Patients can access this clinical trial at the Providence Portland Medical Center (Portland, Oregon), Cedars Sinai Medical Centre (Pittsburgh, Pennsylvania) and Laura And Isaac Perlmutter Cancer Center (West Hollywood, California). There are 7 other accessible sites."
What is the ultimate goal of this clinical investigation?
"Takeda Pharmaceuticals, the trial sponsor, has outlined a range of primary and secondary outcomes. The primary outcome is Dose-limiting Toxicities (DLT), which will be monitored over a 30 month period from initial drug administration. Additionally, Nonirradiated Overall Response Rate (ORRnonirradiated), Irradiated Overall Response Rate (ORRirradiated) and Standard Overall Response Rate (ORR) are being assessed using RECIST V1.1 criteria as predetermined by the investigator."
What pathologies is TAK-676 typically employed to address?
"TAK-676 can be employed to treat malignant neoplasms, inoperable melanoma, and cases of high microsatellite instability."
Approximately how many participants have been included in this research endeavor?
"Takeda, the sponsor of this trial, requires 65 patients to meet their inclusion criteria in order for it to begin. The study will be taking place at Providence Portland Medical Center (Oregon) and Cedars Sinai Medical Centre (Pennsylvania)."
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