Doxorubicin + Dual Checkpoint Blockade for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of chemotherapy and immune-boosting drugs in cancer patients. The goal is to see if this combination works better than chemotherapy alone by helping the body's natural defenses fight cancer more effectively. Combination therapies of chemotherapy and immunotherapy have shown promising results in initial studies, with potential synergistic effects enhancing anti-tumor immunity.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or have had certain treatments like chemotherapy or radiation therapy within 2 weeks before starting the trial. It's best to discuss your current medications with the trial team.
Is the combination of Doxorubicin and Dual Checkpoint Blockade safe for humans?
Doxorubicin, a common chemotherapy drug, has been associated with heart-related side effects (cardiotoxicity) in some patients with soft tissue sarcoma. However, a derivative called Aldoxorubicin shows promise with minimal heart-related side effects, though more studies are needed to confirm its safety.12345
What makes the drug combination of Doxorubicin, AGEN1884, and AGEN2034 unique for treating soft tissue sarcoma?
This treatment combines doxorubicin, a standard chemotherapy drug for soft tissue sarcoma, with AGEN1884 and AGEN2034, which are immune checkpoint inhibitors. This combination aims to enhance the body's immune response against cancer cells, potentially offering a novel approach compared to traditional chemotherapy alone.24678
What data supports the effectiveness of the drug Doxorubicin + Dual Checkpoint Blockade for Soft Tissue Sarcoma?
Research shows that doxorubicin is a standard first-line treatment for soft tissue sarcoma, but its effectiveness is limited. A study combining doxorubicin with another drug, olaratumab, showed improved survival, suggesting that combining doxorubicin with other treatments might enhance its effectiveness.12478
Who Is on the Research Team?
Breelyn Wilky, M.D.
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-In
Initial safety lead-in to evaluate dose-limiting toxicities with combination therapy
Treatment
Participants receive combination therapy with doxorubicin and checkpoint inhibitors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGEN1884 and AGEN2034
- Doxorubicin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Agenus Inc.
Industry Sponsor
National Cancer Institute (NCI)
Collaborator