Ivonescimab + Paclitaxel for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of combining Ivonescimab and Intraperitoneal Paclitaxel (a type of chemotherapy) for individuals with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA). The trial investigates whether these treatments can work together to control the cancer. Participants with this cancer type, who have undergone no more than two previous treatments and are in good overall health, may be suitable for this trial. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous research has shown that intraperitoneal paclitaxel (IP PTX) is generally safe. Common side effects, such as hair loss and anemia, affect 75% and 60% of patients, respectively, and are usually manageable. Most studies suggest that IP PTX is a safe treatment option for various types of cancer.
Early studies on ivonescimab have also shown promising safety results. The treatment has a manageable safety profile, with serious side effects occurring in about 7% of patients, similar to other treatments like pembrolizumab. Overall, ivonescimab appears well-tolerated when used with chemotherapy.
Both treatments have been tested in other studies, showing that most people tolerate them well. This suggests they could be safe for use in the current trial, though individual experiences may vary.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for cancer, which often involve systemic chemotherapy, this new approach combines intraperitoneal paclitaxel with ivonescimab. Ivonescimab is a novel drug that targets specific pathways involved in tumor growth and immune evasion, potentially enhancing the body's immune response against cancer cells. The unique delivery method of paclitaxel directly into the peritoneal cavity allows for higher concentrations at the tumor site, potentially increasing effectiveness while minimizing systemic side effects. Researchers are excited about this combination because it targets the tumor environment more precisely, which may improve outcomes for patients with fewer side effects compared to traditional chemotherapy.
What evidence suggests that Ivonescimab + Paclitaxel might be an effective treatment for Appendiceal Adenocarcinoma?
Research has shown that intraperitoneal paclitaxel holds promise for cancer treatment. In one study, patients with advanced stomach cancer who received this treatment lived an average of 19.4 months. Another study found that this treatment significantly slowed tumor growth in appendiceal cancer models. Ivonescimab, another treatment in this trial, has demonstrated potential in extending the lives of people with non-small cell lung cancer, showing better results in delaying cancer progression compared to other treatments. This trial will evaluate the combination of intraperitoneal paclitaxel and ivonescimab, which together may effectively combat cancers like appendiceal cancer.12345
Who Is on the Research Team?
Beth Helmink, MD
Principal Investigator
UT MD Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with high-grade, metastatic appendiceal adenocarcinoma that cannot be removed by surgery. Participants must have good general health, normal blood counts, and bowel function. They can have had up to two previous treatments but must wait at least 2 weeks since their last therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive paclitaxel intraperitoneally every 2 weeks during cycles 1-5 and ivonescimab intravenously during cycles 2, 3, and 4
Extended Treatment
Participants without disease progression may receive ivonescimab with or without IP paclitaxel every 2-3 weeks for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intraperitoneal Paclitaxel
- Ivonescimab
Trial Overview
The study is testing a combination of Ivonescimab (an experimental drug) and intraperitoneal paclitaxel (a chemotherapy delivered directly into the abdomen) to see if it is safe and effective for treating advanced appendiceal cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo laparoscopy and placement of IP port at least 5 days prior to cycle 1. Patients receive paclitaxel IP over at least 30 minutes every 2-3 weeks during cycles 1-5 and ivonescimab IV over 60-120 minutes every 2 weeks during cycles 2, 3, and 4 only. After 5 cycles (at week 12), patients without disease progression may receive ivonescimab with or without IP paclitaxel every 2-3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy during screening and CT or PET/CT, as well as blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Cancer Prevention Research Institute of Texas
Collaborator
Summit Therapeutics
Industry Sponsor
Citations
Intraperitoneal paclitaxel: pharmacology, clinical results and ...
The 5-year overall survival in these patients was 62%. Intraperitoneal paclitaxel was not effective to improve survival in gastric cancer patients at high risk ...
Intraperitoneal Paclitaxel Combination Regimen Improves ...
DRAGON-01 trial demonstrated a median overall survival of 19.4 months for patients treated with IP paclitaxel plus IV paclitaxel and S-1, ...
Intraperitoneal and Intravenous Paclitaxel Plus S-1 for ...
intraperitoneal and intravenous paclitaxel plus oral S-1 resulted in significantly longer overall survival than intravenous paclitaxel plus S-1 ...
Efficacy and safety of intraperitoneal paclitaxel-based ...
IP paclitaxel showed a 1-year overall survival of 71 % in gastric cancer with PM. • Median survival was 27 months for patients undergoing conversion ...
Efficacy and safety of intraperitoneal paclitaxel based ...
for 785 patients, revealing an overall cumulative 1-year OS of 71% (95% the 1-year OS was 84% (95% CI: 77-89). IP paclitaxel-based regimens ...
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