Vudalimab for Advanced Gynecologic and Genitourinary Cancers
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Xencor, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
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.
What data supports the idea that Vudalimab for Advanced Gynecologic and Genitourinary Cancers is an effective treatment?
The available research shows that Vudalimab, a bispecific antibody targeting PD-1 and CTLA-4, has the potential to be effective in treating advanced cancers. It works by activating certain immune cells, which can help the body fight cancer. Although clinical trials are still in the early stages, the research suggests that Vudalimab might perform better than the combination of other treatments like nivolumab and ipilimumab, which are used for similar purposes. However, more data is needed to confirm its effectiveness specifically for advanced gynecologic and genitourinary cancers.
12345What safety data is available for Vudalimab (XmAb20717)?
The safety data for Vudalimab (XmAb20717) is not directly mentioned in the provided research abstracts. However, the development of bispecific antibodies targeting PD-1 and CTLA-4, like Vudalimab, aims to enhance therapeutic efficacy while potentially minimizing toxicity. The research on similar checkpoint inhibitors, such as ipilimumab (CTLA-4) and pembrolizumab (PD-1), indicates that these treatments are associated with immune-related adverse events. Combination approaches involving CTLA-4 and PD-1/PD-L1 blockade are being investigated to improve efficacy and manage toxicity. The development of bispecific antibodies, such as MEDI5752, is focused on optimizing therapeutic response and minimizing toxicity, which may provide insights into the safety profile of Vudalimab.
26789Is the drug Vudalimab promising for treating advanced gynecologic and genitourinary cancers?
Yes, Vudalimab is promising because it targets two important molecules, PD-1 and CTLA-4, which help the immune system fight cancer. This dual action could potentially be more effective than using separate drugs for each target. Early research shows encouraging results in similar cancers, making it an exciting area for further study.
1461011Eligibility Criteria
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
Able to provide written informed consent
My cancer type has been confirmed through lab tests.
I am 18 years old or older.
+6 more
Exclusion Criteria
Subject is pregnant or breastfeeding or planning to become pregnant while enrolled in the study
I have previously been treated with specific immunotherapy.
I do not have HIV, hepatitis C, or hepatitis B.
+6 more
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: vudalimabExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Karamanos Cancer InstituteDetroit, MI
Winship Cancer Institute, Emory UniversityAtlanta, GA
University of Pennsylvania Health SystemPhiladelphia, PA
Arizona Oncology Associates, PC - NAHOAPrescott, AZ
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Xencor, Inc.Lead Sponsor
ICON plcIndustry Sponsor
References
Bispecific anti-PD-1/CTLA-4 antibody for advanced solid tumors. [2021]PD-1 and CTLA-4 are checkpoint inhibitors of the immune response in cancer, making them the target molecules for the development of therapeutic antibodies. US2019161548 patent describes a bispecific antibody capable of specifically binding to PD-1 and CTLA-4 that induced the proliferation and activation of CD8+ cells, as well as the expression of induclble co-stimulator in CD4+ T cells. Clinical trials to evaluate safety, dose-limiting toxicities and maximum tolerated/administered dose are still in the patient recruitment phase, but it will be of great interest to the scientific and medical community to know if the first bispecific anti-PD-1/CLTA-4 antibody, exceeds expectations and exceeds action of the combination of nivolumab and epilimumab in the treatment of cancer.
Switch-maintenance avelumab immunotherapy following first-line chemotherapy for patients with advanced, unresectable or metastatic urothelial carcinoma: the first Japanese real-world evidence from a multicenter study. [2023]To develop the first Japanese real-world evidence of switch-maintenance avelumab in advanced, unresectable or metastatic urothelial carcinoma (aUC).
Avelumab Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With High-Expression Programmed Death-Ligand 1-Positive Metastatic NSCLC: Primary Analysis From the Phase 3 JAVELIN Lung 100 Trial. [2023]We report the primary analysis from JAVELIN Lung 100, a phase 3 trial comparing avelumab (anti-programmed death-ligand 1 [PD-L1]) versus platinum-based doublet chemotherapy as first-line treatment for PD-L1-positive (+) advanced NSCLC.
Preclinical Characterization of GLS-010 (Zimberelimab), a Novel Fully Human Anti-PD-1 Therapeutic Monoclonal Antibody for Cancer. [2022]Zimberelimab (GLS-010) is a novel fully human monoclonal immunoglobulin G4 (IgG4) against the programmed cell death-1 (PD-1) receptor.
Preoperative CTLA-4 blockade: tolerability and immune monitoring in the setting of a presurgical clinical trial. [2023]Cytotoxic T lymphocyte associated antigen (CTLA-4) blockade is being explored in numerous clinical trials as an immune-based therapy for different malignancies. Our group conducted the first preoperative clinical trial with the anti-CTLA-4 antibody ipilimumab in 12 patients with localized urothelial carcinoma of the bladder.
Clinical Activity, Toxicity, Biomarkers, and Future Development of CTLA-4 Checkpoint Antagonists. [2017]Evidence that the immune system can recognize, and in some cases control or even eliminate tumors, is increasingly clear. Encouraging T-cell activation by blocking regulatory or "checkpoint" molecules is a potent way to amplify anti-tumor immune responses. Successfully exploiting this concept, a new class of anti-cancer therapies, "checkpoint-blocking" antibodies has emerged. The first checkpoint-blocking antibody to enter the clinic was ipilimumab, an antibody that blocks the co-inhibitory receptor cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). Herein we review the clinical development of CTLA-4 blocking antibodies, including preclinical studies, clinical activity, toxicities, the search for potential biomarkers, and early clinical experience with combinations.
Immune Checkpoint Blockade in Cancer Therapy. [2022]Immunologic checkpoint blockade with antibodies that target cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and the programmed cell death protein 1 pathway (PD-1/PD-L1) have demonstrated promise in a variety of malignancies. Ipilimumab (CTLA-4) and pembrolizumab (PD-1) are approved by the US Food and Drug Administration for the treatment of advanced melanoma, and additional regulatory approvals are expected across the oncologic spectrum for a variety of other agents that target these pathways. Treatment with both CTLA-4 and PD-1/PD-L1 blockade is associated with a unique pattern of adverse events called immune-related adverse events, and occasionally, unusual kinetics of tumor response are seen. Combination approaches involving CTLA-4 and PD-1/PD-L1 blockade are being investigated to determine whether they enhance the efficacy of either approach alone. Principles learned during the development of CTLA-4 and PD-1/PD-L1 approaches will likely be used as new immunologic checkpoint blocking antibodies begin clinical investigation.
Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. [2022]The approval of anti-programmed death ligand 1 (PD-L1) and anti-programmed death 1 agents has expanded treatment options for patients with locally advanced or metastatic urothelial carcinoma. Avelumab, a human monoclonal anti-PD-L1 antibody, has shown promising antitumour activity and safety in this disease. We aimed to assess the safety profile in patients (both post-platinum therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug in post-platinum patients.
Bispecific Antibodies to PD-1 and CTLA4: Doubling Down on T Cells to Decouple Efficacy from Toxicity. [2021]Although combination anti-PD-1 and anti-CTLA4 mAbs have revolutionized outcomes for many cancers, their utility has been limited due to significant immune-related toxicities and the emergence of resistance. In this issue of Cancer Discovery, Dovedi and colleagues describe the development and preclinical testing of MEDI5752, a bispecific anti-PD-1/CTLA4 antibody designed to optimize therapeutic response by maximizing CTLA4 blockade on antigen-experienced T cells, thereby increasing efficacy and potentially minimizing toxicity.See related article by Dovedi et al., p. 1100.
Immunologic checkpoints blockade in renal cell, prostate, and urothelial malignancies. [2015]Genitourinary (GU) tumors, and in particular renal cell and prostate cancer, represent one of the most dynamic areas in oncology from the scientific point of view. One of the most recent treatment approaches for GU tumors has focused on a series of molecules known as immune checkpoints and the possibility of manipulating immune responses against tumor cells by blocking these molecules with monoclonal antibodies (mAbs). Cytotoxic T lymphocyte antigen-4 (CTLA-4), and the immune checkpoint inhibitor mAbs ipilimumab and tremelimumab, represent the prototypes of this new growing class of agents called immunomodulating antibodies, while programmed death/ligand 1 (PD-1/PD-L1) also has garnered a significant interest as a new immune checkpoints to target in urothelial cancer, with the anti-PD-1/PD-L1 inhibitor mAbs nivolumab, MPDL-3280, and BMS-936559 as the first agents tested. Here we report the encouraging initial data observed in GU cancers with this new class of agents, which have reinforced the interest of investigating the therapeutic potential of the immune checkpoint modulators in large controlled trials.
Avelumab (anti-PD-L1) in platinum-resistant/refractory ovarian cancer: JAVELIN Ovarian 200 Phase III study design. [2022]Avelumab is a human anti-PD-L1 checkpoint inhibitor with clinical activity in multiple solid tumors. Here, we describe the rationale and design for JAVELIN Ovarian 200 (NCT02580058), the first randomized Phase III trial to evaluate the role of checkpoint inhibition in women with ovarian cancer. This three-arm trial is comparing avelumab administered alone or in combination with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory recurrent ovarian, fallopian tube or peritoneal cancer. Eligible patients are not preselected based on PD-L1 expression and may have received up to three prior lines of chemotherapy for platinum-sensitive disease, but none for resistant disease. Overall survival and progression-free survival are primary end points, and secondary end points include biomarker evaluations and pharmacokinetics.