Combination Therapy to Prevent Resistance to Anti-PD-1 Treatment in Metastatic Ovarian Cancer Patients

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05479045

This study is testing a new treatment strategy using a vaccine to help prevent resistance to anti-PD-1 therapy in women with advanced ovarian cancer that has not responded to standard treatments.

Patient Parameters

Program Overview

This clinical trial is exploring whether a vaccine called NY-ESO-1 can help prevent resistance to anti-PD-1 therapy in women with advanced ovarian cancer that has not responded to platinum-based chemotherapy. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it is non-randomized, with all participants receiving the same treatment. The trial is in Phase II and aims to determine how effective this combination therapy is in managing the disease.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with advanced ovarian cancer that has not responded to platinum-based chemotherapy.
  • Must have cancer that can be measured by scans and has progressed after standard treatment.
  • Must be willing to provide written consent and undergo necessary medical evaluations.
  • Must have recovered from any recent surgery, radiation, or chemotherapy.
  • Must not have any active infections requiring antibiotics, except for simple urinary tract infections.
  • Must have stopped any hormonal therapy for the cancer at least one week before joining the study.
  • Must have stopped any other cancer treatments at least four weeks before joining the study.
  • Must have at least one measurable tumor.
  • Must agree to provide tumor samples for research purposes.
  • Must have a performance status score of 2 or less, indicating they are able to carry out light work.
  • Must have adequate organ function as shown by specific blood tests.
  • Women of childbearing potential must use effective contraception during the study and for 180 days after the last dose.

Exclusion Criteria

  • Previous treatment with certain immune therapies like nivolumab or other similar drugs.
  • Any condition that might interfere with the study or affect safety assessments.
  • Severe allergic reactions to unknown allergens or study drug components.
  • Active or recent autoimmune diseases, except for certain stable conditions.
  • Participation in another clinical study, unless it is non-interventional.
  • Recent use of other cancer treatments not specified in the inclusion criteria.
  • Unresolved side effects from previous cancer treatments.
  • Use of immunosuppressive medication within 14 days before starting the study, with some exceptions.
  • History of primary immunodeficiency, organ transplant, or tuberculosis.
  • Active infections like hepatitis B, C, or HIV.
  • Recent receipt of live vaccines.
  • Pregnant or breastfeeding women.
  • Recent major surgery or still recovering from surgery.
  • Other invasive cancers within the last two years, except for certain non-invasive cancers.
  • Uncontrolled illnesses or conditions that could interfere with the study or increase risks.

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