NY-ESO-1 Vaccine + Nivolumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySamir N Khleif, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Georgetown University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Samir N Khleif, MD

Principal Investigator

Georgetown University

Eligibility Criteria

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.

Inclusion Criteria

You have fully recovered from any recent surgery, radiotherapy, or chemotherapy.

Subjects will be eligible for study entry based on the following diagnostic workup: History/physical examination within 28 days prior to registration, Imaging of target lesion(s) within 28 days prior to registration, Recovery from effects of recent surgery, radiotherapy or chemotherapy, Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection), Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration, Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C), Any prior radiation therapy must be completed at least 4 weeks prior to registration, At least 4 weeks must have elapsed since major surgery, Subjects must have received and have progressed, are refractory, or are intolerant to standard platinum therapy, Subjects should not have received more than 2 prior lines of systemic therapy for recurrent or metastatic disease (including both standard of care and investigational therapies), Subjects must have at least 1 lesion that is measurable using RECIST Version 1.1 guidelines, A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST Version 1.1, and has clearly progressed, Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator (optional), Subjects must consent to provide archived tumor specimens for correlative biomarker studies, Tumor tissue must be identified and availability confirmed prior to initiation of study therapy, In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy, All subjects are encouraged to consent to and provide both pretreatment and on-treatment (optional) tumor biopsies, Eastern Cooperative Oncology Group (ECOG) Performance score of 2 or less, In the opinion of the investigator likely to complete ≥ 8 weeks of treatment, Adequate organ function as determined by: Hematological, Renal, Hepatic, Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product, Females of childbearing potential are defined as those who are not surgically sterile (i.e., have not undergone bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause), A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, Subjects must refrain from breastfeeding while on study and for 180 days after the final dose of investigational product

Be able and willing to provide written and signed informed consent prior to performing any protocol-related procedures, including screening evaluations

See 1 more

Exclusion Criteria

You have had a very severe allergic reaction to any unknown allergens or any components of the study drug formulations.

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

You have had an autoimmune disease like Crohn's disease or lupus in the past 2 years. If you have conditions like asthma or vitiligo, or if your autoimmune disease is stable with hormone or steroid replacement, you are not excluded.

See 6 more

Treatment Details

Interventions

Nivolumab (PD-1/PD-L1 Inhibitor)
NY-ESO-1 Peptide vaccine (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

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

Nivolumab is already approved in Canada, Switzerland for the following indications: