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Study Summary
This trial is testing the safety and effectiveness of TAK-981 in people with advanced solid tumors or lymphomas.
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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- I have not had another type of cancer in the last 3 years.My cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.I have at least one tumor that can be measured on scans.I have an autoimmune disease and take medication to suppress my immune system.You have a mental health condition or personal situation that could make it difficult for you to follow the study guidelines.You have used illegal drugs, abused prescription drugs, or have a history of alcohol abuse.I have cervical cancer and have had only one treatment for it since it became advanced.I haven't taken any cancer drugs or been in a trial within the last 14 days.I have not had serious heart problems in the last 6 months.My advanced cancer is incurable and standard treatments have failed.I agree to have tumor biopsies before and during treatment.My nonsquamous NSCLC progressed after 1-2 treatments but didn't worsen in the first 5 months of the first CPI therapy.My cancer is advanced or has spread, and standard treatments haven't worked or I've refused them.I have had lung inflammation or lung disease that needed steroids.I have advanced cancer or lymphoma with no standard treatment options left.My cancer progressed despite targeted therapy for specific genetic changes.I have recovered from previous cancer treatments, except for hair loss, nerve issues, or stable hormone conditions.I am 18 years old or older.I stopped an immune therapy due to side effects.I have lung inflammation not caused by an infection.I am currently fighting a serious infection.I am not pregnant, breastfeeding, or lactating.I am fully active or can carry out light work.My kidney, liver, and bone marrow are functioning well.I had major radiotherapy less than 4 weeks ago and still have side effects.I have had a transplant of tissue or an organ from another person.I am willing to provide a sample of my tumor if it's available.I am taking medication that strongly affects how drugs are processed in my body.I need to take medication that can affect my heart's rhythm.My first cancer treatment included platinum-based drugs but not with primary radiation.I have colorectal cancer, haven't had CPI treatment, and tried up to 3 chemo types.My cervical cancer is not one of the excluded types and has been confirmed by a pathology report.I am 18 years old or older.I can carry out all my daily activities without help.
- Group 1: Phase 2, Cohort A: Nonsquamous NSCLC
- Group 2: Phase 2, Cohort C: MSS-CRC
- Group 3: Phase 2, Cohort D: r/r DLBCL after CAR T-cells therapy
- Group 4: Phase 2, Cohort E: r/r DLBCL without prior cellular therapy
- Group 5: Phase 2, Cohort F: r/r Follicular Lymphoma
- Group 6: Phase 1, Dose Escalation Cohort: TAK-981
- Group 7: Phase 2, Cohort B: Cervical Cancer
- 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
Is this an innovative clinical trial?
"There are 4 ongoing clinical trials for TAK-981 across 67 cities and 10 countries. The first study was held in 2018 and completed both Phase 1 & 2 of drug approval. Since then, 1 trial has been conducted every year."
Are there any current openings for participants in this trial?
"This clinical trial, as indicated by the website clinicaltrials.gov is recruiting patients at this time. The first posting for this trial was on October 1st 2018 with the most recent update taking place on April 18th 2022."
How many people are allowed to participate in this clinical trial at one time?
"In order to carry out this research, 202 patients who meet the necessary requirements must be recruited. Takeda, the sponsor of the trial, will manage it from various locations - two being Fox Chase Cancer Center in Philadelphia and Froedtert and the Medical College of Wisconsin in Milwaukee."
What other medical experiments have included TAK-981?
"Currently, there are 4 different ongoing research studies on TAK-981. 0 of these trials have reached Phase 3 clinical stages. The majority of the 106 locations running these tests are based in Pittsburgh, Pennsylvania; however, other states are represented as well."
Is this study happening at a lot of different hospitals in the US?
"This study is currently recruiting at 7 locations, which include Fox Chase Cancer Center in Philadelphia, Froedtert and the Medical College of Wisconsin in Milwaukee, Massachusetts General Hospital in Boston, as well as 4 other sites."
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