NeoVax + Nivolumab for Ovarian Cancer

Overseen By Panagiotis Konstantinopoulos, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a custom-made vaccine for ovarian cancer, used with Nivolumab. It targets ovarian cancer patients who need new treatment options. The vaccine boosts the immune response using the patient's own cancer proteins, while Nivolumab keeps the immune system active.

Research Team

Panagiotis Konstantinopoulos, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for women over 18 with certain types of ovarian cancer who are in good health and not pregnant. They must have a performance status indicating they can care for themselves, agree to use contraception, and be willing to follow the study's procedures. Those with non-epithelial tumors, serious illnesses besides cancer, or recent major surgery cannot join.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I am 18 years old or older.

I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

Exclusion Criteria

Pregnant or nursing women

I have or had an autoimmune disease, with some exceptions.

Underlying medical condition, psychiatric condition, or social situation that would compromise study administration as per protocol or compromise the assessment of AEs

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 NeoVax immunizations over a 3-week period, with two booster vaccinations at Week 12, and Nivolumab administered by IV infusion every 2 weeks

12 weeks

5 visits (in-person) for immunizations, bi-weekly visits for Nivolumab infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• NeoVax
• Nivolumab

Trial Overview The study tests a new vaccine called NeoVax alongside Nivolumab (Opdivo®) in patients with ovarian cancer. Participants will receive both treatments and be monitored to see how well they work together against their cancer.

Participant Groups

Group I: Stanfard Platinum with Surgical or Core Needle Biopsy Experimental Treatment 3 Interventions

* A total of 5 NeoVax immunizations will be administered over a 3-week period * Two booster vaccinations will be given at Week 12 * Nivolumab administered by intravenous (IV) infusion over 30 minutes every 2 weeks. * Will undergo required surgical or core needle biopsy at first recurrence with progression free interval

Group II: Stanfard Platinum Experimental Treatment 2 Interventions

* A total of 5 NeoVax immunizations will be administered over a 3-week period * Two booster vaccinations will be given at Week 12 * Nivolumab administered by intravenous (IV) infusion over 30 minutes every 2 weeks.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+