What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors used in prostate cancer treatment, such as PD-1 and CTLA-4 inhibitors, include fatigue, skin rash, and gastrointestinal issues like diarrhea and colitis. More severe but less frequent side effects can involve pneumonitis, hepatitis, thyroid dysfunction, and nephritis, due to the immune system attacking normal tissues.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of prostate cancer. Pembrolizumab, an anti-PD-1 antibody, has been approved for metastatic castration-resistant prostate cancer (mCRPC) with specific genetic features such as high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). Additionally, the combination of atezolizumab (anti-PD-L1) with enzalutamide has been studied, although not yet approved, for mCRPC. Ipilimumab, an anti-CTLA-4 antibody, has also been evaluated in clinical trials for prostate cancer but has not received FDA approval for this indication. These treatments are similar to Vudalimab (XmAb20717), which targets both PD-1 and CTLA-4 to potentially enhance the immune response against cancer.

What other types of research exist?

Promising novel alternatives to Vudalimab (XmAb20717) for prostate cancer patients in 2024 include: 1) Pembrolizumab (Keytruda) - a PD-1 inhibitor showing efficacy in various cancers, including prostate cancer. 2) Nivolumab (Opdivo) - another PD-1 inhibitor with potential benefits in prostate cancer. 3) Ipilimumab (Yervoy) - a CTLA-4 inhibitor that can be used alone or in combination with PD-1 inhibitors. 4) Bispecific T cell engagers (BiTEs) such as AMG 160, targeting PSMA and CD3, showing promise in clinical trials. 5) CAR-T cell therapies targeting prostate-specific membrane antigen (PSMA), which are in early-phase trials but show potential for durable responses.

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Monoclonal Antibodies

Vudalimab for Advanced Gynecologic and Genitourinary Cancers

Phase 2

Recruiting

Research Sponsored by Xencor, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of specific tumor types with additional clinical/pathologic confirmation

Adult (age ≥ 18 years)

Must not have

Prior treatment with specific immunotherapy agents

Specific criteria related to HIV, hepatitis C, and hepatitis B infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called vudalimab in patients with hard-to-treat advanced gynecologic and genitourinary cancers. The drug aims to boost the immune system's ability to fight cancer by making cancer cells more visible to immune cells.

Who is the study for?

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.

What is being tested?

The trial is testing Vudalimab (XmAb20717) on patients with specific advanced cancers of the reproductive organs and urinary system. It's an open-label Phase 2 study, meaning both researchers and participants know what treatment is being given, aiming to assess how well it works and its safety.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions seen with immunotherapy such as fatigue, skin reactions, inflammation of organs like the liver or lungs (hepatitis or pneumonitis), flu-like symptoms, hormonal gland issues (like thyroid dysfunction), and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer type has been confirmed through lab tests.

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I am 18 years old or older.

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My cancer has worsened despite all suitable treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My prostate cancer is advanced and not responding to hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with specific immunotherapy.

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I do not have HIV, hepatitis C, or hepatitis B.

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I have undergone more than 2 chemotherapy treatments for my cancer.

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I have a history of serious bowel issues, organ transplant, or severe infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: vudalimabExperimental Treatment1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer, particularly those involving immune checkpoint inhibitors like Vudalimab (XmAb20717), work by targeting proteins such as PD-1 and CTLA-4. These proteins typically downregulate the immune response, but by inhibiting them, these treatments can enhance the body's ability to recognize and attack cancer cells. This mechanism is crucial for prostate cancer patients, especially those who have not responded to other therapies, as it provides an alternative approach to managing and potentially overcoming the disease.