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Monoclonal Antibodies
Doxorubicin + Dual Checkpoint Blockade for Soft Tissue Sarcoma
Phase 2
Recruiting
Led By Breelyn Wilky, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1 (See Appendix B for scale definitions).
Have a histological diagnosis of advanced or metastatic soft tissue sarcoma (STS) (by local pathology review), not curable by surgery, for which treatment with doxorubicin is deemed appropriate by the investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
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.
Who is the study for?
Adults aged 18-100 with advanced or metastatic soft tissue sarcoma, suitable for doxorubicin treatment, and who haven't had anthracyclines or checkpoint inhibitors before. They must have good organ function, an ECOG status of 0 or 1, be willing to undergo biopsies and use effective contraception. Exclusions include prior certain treatments, immune deficiencies, active infections/autoimmune diseases, CNS metastases not stable/treated within a month.Check my eligibility
What is being tested?
The trial is testing the effectiveness of doxorubicin combined with two immunotherapy drugs (AGEN1884 and AGEN2034) in treating soft tissue sarcomas. It's an open-label Phase II study where all participants receive the same treatment without randomization. The main goal is to see if this combo improves progression-free survival at six months compared to historical data from doxorubicin alone.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in different organs due to dual checkpoint blockade therapy; typical chemotherapy-related issues like nausea and hair loss from doxorubicin; fatigue; increased risk of infection; blood disorders; and possible infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My soft tissue sarcoma cannot be cured by surgery and doxorubicin is considered suitable for me.
Select...
I am between 18 and 100 years old.
Select...
I have had at most one treatment for metastatic sarcoma and no treatments with anthracyclines or checkpoint inhibitors.
Select...
I am between 18 and 100 years old.
Select...
My sarcoma cannot be removed by surgery and doxorubicin is considered suitable for me.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have or will get a central venous catheter placed for treatment.
Select...
I have had at most one treatment for my metastatic sarcoma and no treatments with anthracyclines or checkpoint inhibitors.
Select...
I have or will get a central venous catheter placed for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the progression-free survival rate
Secondary outcome measures
Determine the clinical benefit rate
Determine the duration of response
Determine the incidence of adverse events
+1 moreOther outcome measures
Measure changes in tumor-infiltrating and circulating immune cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: doxorubicin with AGEN1884 and AGEN2034Experimental Treatment1 Intervention
Doxorubicin with dual checkpoint blockade with anti-CTLA-4 antibody AGEN1884 and anti-PD-1 antibody AGEN2034. Doxorubicin dosing is standard at 75 mg/m2 via Bolus with prior Dexrazoxane. AGEN2034 - 300 mg IV over 60min with infusion pump. AGEN1884 - 1 mg/kg IV over 90 min (-10 /+20 min) with infusion pump, within 30 minutes (0 / +20) of completion of AGEN2034.
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Who is running the clinical trial?
Agenus Inc.Industry Sponsor
51 Previous Clinical Trials
4,707 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,742 Previous Clinical Trials
2,152,731 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,930,528 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: doxorubicin with AGEN1884 and AGEN2034
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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