A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07753824
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Appendiceal Adenocarcinoma
  • High Grade Metastatic
  • Intraperitoneal
  • Ivonescimab
  • Paclitaxel
  • Phase II

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    Given by IV
  • IP PTX — DRUG
    Given by IP port

Study Details

To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).

Key Dates

First listed
Aug 10, 2026
Start date
Jan 16, 2027
Status verified
Aug 2026
Primary completion
Nov 28, 2031
Completion
Nov 28, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (IP PTX, ivonescimab)
    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.

Primary Outcome Measure

Safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030
Beth Helmink, MD
[email protected]
832-696-5784

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By research site
UT MD Anderson Cancer Center· Houston, TX

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