What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, including immunotherapy, targeted therapies, and chemotherapy, have various side effects. Immunotherapy, such as anti-PD1 agents, can cause immune-related adverse events like fatigue, rash, diarrhea, and endocrinopathies. Targeted therapies, such as bevacizumab and PARP inhibitors, can lead to hypertension, proteinuria, gastrointestinal perforations, and hematologic toxicities. Chemotherapy agents, including carboplatin and paclitaxel, often result in nausea, vomiting, hair loss, neuropathy, and myelosuppression. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, particularly focusing on targeted therapies and immunotherapies. Bevacizumab, an angiogenesis inhibitor, has been approved for use in combination with chemotherapy for advanced ovarian cancer. PARP inhibitors like olaparib, niraparib, and rucaparib have been approved for maintenance therapy in patients with BRCA-mutated ovarian cancer. Additionally, pembrolizumab, an anti-PD1 antibody, has been approved for use in certain cases of ovarian cancer, particularly those with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments align with the strategy of using targeted and immune-based therapies to manage ovarian cancer.

What other types of research exist?

Promising novel alternatives to the NY-ESO-1 peptide vaccine for ovarian cancer patients include: 1) Combination therapies involving immune checkpoint inhibitors like pembrolizumab or nivolumab with other agents such as PARP inhibitors (e.g., olaparib) or anti-angiogenic drugs (e.g., bevacizumab). 2) Personalized cancer vaccines targeting specific tumor antigens identified through genomic profiling. 3) Adoptive cell therapies, including CAR-T cells and TIL (tumor-infiltrating lymphocytes) therapy. 4) Bispecific T-cell engagers (BiTEs) that direct T-cells to target cancer cells. These approaches are currently under investigation and have shown potential in enhancing anti-tumor responses and overcoming resistance mechanisms.

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PD-1/PD-L1 Inhibitor

NY-ESO-1 Vaccine + Nivolumab for Ovarian Cancer

Phase 2

Waitlist Available

Led By Samir N Khleif, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a vaccine that helps the immune system fight cancer in patients with advanced ovarian cancer who don't respond to standard treatments. The vaccine aims to make other treatments more effective by preventing resistance. Special immune cells are used in this therapy.

Who is the study for?

This trial is for women aged 18 or older with stage III/IV platinum-refractory ovarian cancer who have progressed on standard treatment, including those with BRCA mutations. Participants must have recovered from recent surgery or therapy, not be on active infection antibiotics (except simple UTI), and agree to use effective contraception. Exclusions include prior nivolumab or similar therapies, autoimmune diseases within the past 2 years, other concurrent clinical trials, and certain medical conditions.

What is being tested?

The study tests a combination of NY-ESO-1 Peptide vaccine and Nivolumab in patients with advanced ovarian cancer resistant to platinum-based chemotherapy. It's an open-label phase II trial aiming to prevent resistance to anti-PD-1 therapy by using the vaccine as a priming agent before administering Nivolumab.

What are the potential side effects?

Potential side effects may include typical immune-related reactions such as inflammation in various organs due to immune system activation by Nivolumab. The NY-ESO-1 vaccine could cause injection site reactions, flu-like symptoms including fever and chills, fatigue, muscle pain, and possible allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease Control Rate

Duration of Response

Incidence of Adverse Events (AE)

+2 more

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: NY-ESO-1 Peptide vaccine plus Toripalimab-tpziExperimental Treatment2 Interventions

Do I qualify?Apply below to find out

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 ovarian cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as carboplatin and paclitaxel, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, like PARP inhibitors, exploit specific genetic vulnerabilities in cancer cells, such as BRCA mutations, to prevent DNA repair and induce cell death. Immunotherapy, including anti-PD1 agents like nivolumab, enhances the immune system's ability to recognize and destroy cancer cells. The NY-ESO-1 peptide vaccine, studied as a priming mechanism, aims to prevent resistance to anti-PD1 therapy by stimulating an immune response against cancer cells expressing the NY-ESO-1 antigen. This is crucial for ovarian cancer patients as it may improve the efficacy of immunotherapy and prolong progression-free survival.

Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.