Ivonescimab + Paclitaxel for Cancer

BH
Overseen ByBeth Helmink, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

BH

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

Adequate hematology function: no blood components or growth factor therapy within 7 days prior, ANC ≥ 1500/mm3 (≥1000/mm3 for African American participants), platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9.0 g/dL
I have had two or fewer previous systemic treatments, with my last dose over 2 weeks ago.
I am 18 years old or older.
See 10 more

Exclusion Criteria

I have or had inflammatory bowel disease.
Medical, surgical, psychiatric, or laboratory conditions that may confound study results or increase risk or interfere with participation
Psychiatric illness or social situations limiting compliance with study requirements
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive paclitaxel intraperitoneally every 2 weeks during cycles 1-5 and ivonescimab intravenously during cycles 2, 3, and 4

12 weeks
5 visits (in-person)

Extended Treatment

Participants without disease progression may receive ivonescimab with or without IP paclitaxel every 2-3 weeks for up to 2 years

Up to 2 years
Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
3 visits (in-person)

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

Group I: Treatment (IP PTX, ivonescimab)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials
55
Recruited
98,900+

Summit Therapeutics

Industry Sponsor

Trials
18
Recruited
4,500+

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 ...