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Doxorubicin + Dual Checkpoint Blockade for Soft Tissue Sarcoma
Study Summary
This trial is testing a new combination of drugs to see if it is more effective than just one of the drugs for treating cancer.
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 haven't had cancer antibody treatment in the last 4 weeks or have recovered from its side effects.I am fully active or restricted in physically strenuous activity but can do light work.I am willing and able to follow the study rules and attend all required visits.My soft tissue sarcoma cannot be cured by surgery and doxorubicin is considered suitable for me.I am between 18 and 100 years old.I am a male and agree to use contraception during and for 120 days after the study.I have had at most one treatment for metastatic sarcoma and no treatments with anthracyclines or checkpoint inhibitors.I have an immune deficiency or a chronic infection like HIV, hepatitis, or TB.I have not received a live vaccine within the last 30 days.I am between 18 and 100 years old.My cancer is one of the specified rare types, not commonly treated.I haven't had cancer treatment in the last 2 weeks and have recovered from any previous treatments.I have had lung inflammation treated with steroids in the last year.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I agree to use two effective birth control methods or not have sex if I can have children.I have previously been treated with anthracycline or checkpoint inhibitors.I have stable blood clot issues and haven't had serious GI bleeding in the last 6 months.I have stable brain metastases, not needing steroids for 28 days, and no signs of new growth.I am not pregnant and can become pregnant based on my medical history.My sarcoma cannot be removed by surgery and doxorubicin is considered suitable for me.My organs are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.I have or will get a central venous catheter placed for treatment.My organs are functioning well.I agree to have tumor biopsies at the start, during treatment, and possibly if my cancer progresses.My cancer can be measured or evaluated by specific medical criteria.I agree to use two effective birth control methods or not have sex if I can have children.I have had at most one treatment for my metastatic sarcoma and no treatments with anthracyclines or checkpoint inhibitors.My cancer can be measured or evaluated by specific criteria.I agree to have tumor biopsies at the start, during treatment, and possibly if my cancer progresses.I have no active cancer except for treated skin cancer or in situ cervical cancer.I am a male and agree to use contraception during and for 120 days after the study.You should not become pregnant while being treated.I have or will get a central venous catheter placed for treatment.I do not have any uncontrolled illnesses like infections or heart problems.I have an immune system disorder or take medication that weakens my immune system.My cancer is one of the listed rare types, not a common form.
- Group 1: doxorubicin with AGEN1884 and AGEN2034
- 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 experiment unprecedented in its approach?
"Doxorubicin combined with AGEN1884 and AGEN2034 has been studied since Alfacell sponsored its initial study in 1997, recruiting 300 participants. After the Phase 3 drug approval process was completed, 366 clinical trials have emerged across 1967 cities and 66 countries."
Are prospective participants able to join this trial at this time?
"This clinical investigation is currently not recruiting patients, having been initially posted on the 28th of January 2020 and last edited on April 26th 2022. Nonetheless, other 809 trials are actively seeking study participants at this time."
Is there a possibility for me to partake in this research?
"To qualify for consideration, applicants must have metastatic soft tissue sarcoma and be between 18-100 years old. 28 people are slated to participate in the medical study."
Has the FDA authorized the combination of doxorubicin with AGEN1884 and AGEN2034?
"Based on the available data, our team at Power has rated doxorubicin with AGEN1884 and AGEN2034 a 2 in terms of safety. As this is currently a Phase 2 trial, there are some indications of safety but no efficacy information yet."
What is the aggregate amount of participants in this clinical experiment?
"This research protocol is no longer recruiting participants, having first been published on January 28th 2020 and most recently updated April 26th 2022. On the other hand, 443 trials related to metastatic soft tissue sarcoma are currently enrolling patients and 366 studies for doxorubicin with AGEN1884 and AGEN2034 are actively searching for participants."
Are there any records of previous examinations on the effects of doxorubicin with AGEN1884 and AGEN2034?
"Presently, there exist 366 clinical trials for doxorubicin with AGEN1884 and AGEN2034. Of those, 119 are in Phase 3. Although most of these medical studies take place in New york City, the overall number of locations is 23752."
Does this trial accept volunteers of age forty and above?
"As per the regulations of this clinical trial, eligible participants must be aged 18 or over and no more than 100 years old."
What medical treatments are doxorubicin with AGEN1884 and AGEN2034 typically administered for?
"Doxorubicin in combination with AGEN1884 and AGEN2034 is regularly administered to treat lymphoma, hodgkins, carcinoma, bronchogenic cancer, neuroblastoma (nb), and Sezary syndrome."
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