Vudalimab for Advanced Gynecologic and Genitourinary Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called vudalimab for individuals with advanced gynecologic (female reproductive system) and genitourinary (urinary and male reproductive systems) cancers. The goal is to determine if vudalimab can safely and effectively treat these cancers, especially when other treatments have failed. It suits those whose cancer has returned or continued to grow despite standard treatments like chemotherapy. Participants must have specific types of cancer, such as ovarian, cervical, or prostate cancer, and should be willing to follow the study schedule. As a Phase 2 trial, this research measures how well vudalimab works in an initial, smaller group of people, offering early access to a potentially effective treatment.
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other anticancer therapies, except for certain hormone therapies for prostate cancer. If you're on systemic corticosteroids or immunosuppressive medications, you must stop them 14 days before starting the trial drug.
Is there any evidence suggesting that vudalimab is likely to be safe for humans?
Research has shown that vudalimab (also known as XmAb20717) is under investigation for its safety in individuals with advanced gynecologic and genitourinary cancers. While specific safety details from these studies are not provided, it is important to note that this treatment is in Phase 2 trials. This phase indicates that it demonstrated some safety in early trials and is now being tested in larger groups to further assess its effects and potential side effects.
Vudalimab is a bispecific antibody, designed to target cancer cells more precisely, potentially reducing unwanted side effects. However, like any new treatment, risks exist, and side effects may vary.
Prospective trial participants should remember that researchers closely monitor safety and prioritize participants' well-being. Discuss any concerns with the study team to understand what to expect.12345Why do researchers think this study treatment might be promising?
Vudalimab is unique because it targets both PD-1 and CTLA-4 pathways, which are crucial checkpoints in the immune system that help cancer cells evade detection. Unlike standard treatments for advanced gynecologic and genitourinary cancers, which often rely on chemotherapy or single checkpoint inhibitors, Vudalimab combines dual checkpoint inhibition in one therapy. This dual action could potentially enhance the immune system's ability to fight cancer more effectively, offering a new hope for patients with advanced stages of these cancers. Researchers are excited because this approach may lead to better outcomes with possibly fewer side effects compared to traditional treatments.
What evidence suggests that vudalimab might be an effective treatment for advanced gynecologic and genitourinary cancers?
Research shows that vudalimab, also known as XmAb20717, is designed to help the immune system fight certain advanced gynecologic and genitourinary cancers. In early studies, vudalimab showed promise by targeting two proteins, PD-1 and CTLA-4, which normally prevent the immune system from attacking cancer cells. These proteins can act like shields for cancer, and vudalimab works to remove them. Initial findings suggested that patients with advanced solid tumors experienced some positive outcomes when treated with vudalimab. While more research is needed to fully understand its effectiveness, the early results are encouraging for those with these hard-to-treat cancers.23456
Who Is on the Research Team?
Jolene Shorr
Principal Investigator
Xencor, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced gynecologic and genitourinary cancers that have worsened despite all approved treatments or when no suitable treatments are available. Participants must be in good physical condition, agree to use effective birth control, and commit to the study schedule. Those who've had more than two chemo treatments for some cancers or recent other cancer therapies can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 Treatment
Participants receive vudalimab in tumor-specific cohorts to evaluate efficacy and safety
Stage 2 Treatment
Additional subjects are enrolled in cohorts with ORR ≥ 20% for further evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vudalimab (XmAb20717)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xencor, Inc.
Lead Sponsor
ICON plc
Industry Sponsor
Dr. Steve Cutler
ICON plc
Chief Executive Officer since 2017
PhD from the University of Sydney, MBA from the University of Birmingham
Dr. Greg Licholai
ICON plc
Chief Medical Officer since 2023
Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College