22 Participants Needed

NeoVax + Nivolumab for Ovarian Cancer

Panagiotis Konstantinopoulos, MD, PhD profile photo
Overseen ByPanagiotis Konstantinopoulos, MD, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Dana-Farber Cancer Institute
Must be taking: Platinum-based chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Dana-Farber Cancer Institute ...

Panagiotis Konstantinopoulos, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.
Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study treatment and 5 months after the last dose of study treatment
See 6 more

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
See 12 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Stanfard Platinum with Surgical or Core Needle BiopsyExperimental Treatment3 Interventions
Group II: Stanfard PlatinumExperimental Treatment2 Interventions

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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