Ivonescimab for Adrenocortical Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if ivonescimab, a potential new drug, can help manage adrenocortical carcinoma (ACC) or pheochromocytoma and paraganglioma (PPGL) that have spread or recurred after other treatments. The study will assess how effectively this treatment controls these cancers. This trial may suit individuals with confirmed ACC or PPGL that has progressed and is not suitable for surgery. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that ivonescimab is likely to be safe for humans?
Research has shown that ivonescimab generally has a manageable safety profile. In previous studies, about 14.6% of patients experienced serious side effects, known as Grade 3–4 adverse events, including low white blood cell counts and lung inflammation. However, these effects are similar to those expected from other treatments and can usually be managed.
Ivonescimab has undergone testing in other global trials, demonstrating a good balance between its tumor-fighting ability and its manageable safety profile. While some risks exist, most patients can tolerate the treatment well.12345Why do researchers think this study treatment might be promising for ACC?
Ivonescimab is unique because it represents a novel approach to treating adrenocortical carcinoma (ACC) by specifically targeting cancer cells. While most standard treatments for ACC, like mitotane or chemotherapy, rely on broadly attacking rapidly dividing cells, ivonescimab works by harnessing and enhancing the body's own immune system to fight cancer more precisely. Researchers are particularly excited about its potential to reduce side effects and improve outcomes by focusing the treatment on the tumor cells while sparing healthy ones. This targeted action could lead to more effective and personalized treatment options for patients with ACC.
What evidence suggests that ivonescimab might be an effective treatment for ACC or PPGL?
Research has shown that ivonescimab yields promising results for cancer patients. In studies on non-small cell lung cancer, ivonescimab treatments significantly improved the disease control rate (DCR) compared to traditional chemotherapy. Specifically, patients receiving ivonescimab lived longer on average, with a survival time of 27.9 months compared to 23.7 months for those in the control group. The treatment also extended the period during which the cancer did not worsen. This trial will evaluate ivonescimab for adrenocortical carcinoma (ACC), and these findings suggest that ivonescimab could effectively manage advanced cancers like ACC.16789
Who Is on the Research Team?
Matthew Campbell, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced or inoperable adrenal gland cancers (ACC or PPGL) that have already been treated but keep growing. Participants must be generally healthy aside from their cancer and able to attend study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ivonescimab intravenously every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ivonescimab
Trial Overview
The study is testing ivonescimab, a new medication, to see if it can help control ACC or PPGL tumors that can't be removed by surgery. All participants will receive this drug through an IV infusion.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Treatment with Ivonescimab (IV) Q3W For PPGL Suspended: No
Treatment with Ivonescimab (IV) Q3W For ACC
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Summit Therapeutics
Industry Sponsor
Citations
Efficacy and safety of ivonescimab in non-small cell lung cancer
Analysis of RCT data indicated that AK112-based regimens significantly improved DCR compared to conventional chemotherapy (OR = 2.29, 95% CI: 1.18–4.44; Figure ...
2.
cancertherapyadvisor.com
cancertherapyadvisor.com/reports/ivonescimab-plus-chemo-efficacy-may-vary-across-populations/Efficacy of Ivonescimab Plus Chemo May Vary Across ...
The median OS was 16.8 months in the ivonescimab arm and 14.0 months in the control arm (HR, 0.79; 95% CI, 0.62-1.01; P =.0570). Among patients ...
Akeso, Inc | Ivonescimab Receives NMPA Approval for First ...
Ivonescimab demonstrated a statistically significant improvement in the trial's primary end point, median progression-free survival (PFS)
NCT07743138 | STOMP OUT: A Phase 2 Study To ...
Study Overview. Brief Summary. To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.
📊 Research Summary: Ivonescimab plus chemotherapy ...
Ivonescimab significantly improved the objective response rate (50.0% vs. 38.5%) and disease control rate (89.9% vs. 70.5%) for PD-L1 positive ...
Safety, Pharmacokinetics, and Pharmacodynamics Evaluation ...
As of data cutoff on July 30, 2023, the median follow‐up was 24.1 months (range: 1.7–30.3 months). Ivonescimab treatment was still ongoing for one of 6 patients ...
Encouraging Global Phase II Ivonescimab Data in First- ...
While progression-free survival (PFS) analysis is still immature in this study, the landmark 9-month PFS rate was 76.1% for those patients ...
What diseases does Ivonescimab treat?
The comprehensive safety data, derived from global clinical trials, underscores the balance between potent antitumor efficacy and manageable ...
ak117-hnscc.pdf
• Here, we present data on the efficacy and safety of ivonescimab, both with and without ligufalimab, in patients with PD-L1–positive R/M ...
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