NeoVax + Nivolumab for Ovarian Cancer

Overseen By Panagiotis Konstantinopoulos, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Must be taking: Platinum-based chemotherapy

Must not be taking: Immunotherapy, Corticosteroids

Disqualifiers: Autoimmune disease, Brain metastases, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer vaccine (NeoVax) combined with the drug Nivolumab to evaluate their effectiveness against ovarian cancer. Researchers aim to determine if this combination can fight the cancer more effectively. Participants will receive several doses of the vaccine and regular infusions of Nivolumab. This trial suits women with newly diagnosed or recurrent ovarian, fallopian tube, or primary peritoneal cancer who can undergo a biopsy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you must stop them at least 14 days before starting the study drug. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of NeoVax and Nivolumab is being tested for safety in patients with ovarian cancer. Previous studies have found that NeoVax, a personalized cancer vaccine, is safe and generally well-tolerated. It enhances the immune system's response without causing serious side effects. Nivolumab, already approved for other uses, is usually safe but can sometimes cause mild to moderate side effects like tiredness or a skin rash.

This trial is in an early stage, focusing primarily on safety. Past studies suggest that using NeoVax and Nivolumab together does not raise major safety concerns. However, participants might still experience some side effects, as is common with most cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NeoVax and Nivolumab for ovarian cancer because these treatments offer a unique approach. Unlike current treatments such as chemotherapy, which attacks rapidly dividing cells, NeoVax is a personalized cancer vaccine designed to stimulate the immune system to recognize and attack tumor cells. Nivolumab, on the other hand, is an immune checkpoint inhibitor that helps to unleash the immune system's full potential by blocking proteins that prevent immune cells from attacking cancer. This combination aims to create a powerful immune response tailored specifically to the patient's cancer, potentially leading to more effective and durable results.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that NeoVax, a personalized cancer vaccine, has potential to create strong immune responses. Early studies found that patients who received NeoVax lived longer, with some having a 72% chance of surviving for two years. Nivolumab has effectively treated ovarian cancer, with patients experiencing an average of 3.5 months before the cancer worsens. It can also extend overall survival, with some patients living up to 20 months. In this trial, participants will receive both NeoVax and Nivolumab, which might enhance the immune system's ability to fight ovarian cancer, offering hope to those affected. ^{1 3 6 7 8}

Who Is on the Research Team?

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

Exclusion Criteria

Pregnant or nursing women

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

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

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?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04024878

NeoVax With Nivolumab in Patients With Ovarian Cancer The purpose of this study is to determine if it is possible to make and administer safely a vaccine against ovarian cancer by using information gained from ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.2637

Phase 1 studies of personalized neoantigen vaccine ... Results: At the time of the data cut-off, a total of 8 pts were treated: 4 relapsing OC pts, 3 HNSCC pts in complete remission and 1 relapsing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6592278/

Personalized vaccination against ovarian cancer This study showed that vaccination with tumor-pulsed DCs resulted in longer survival (72 % and 31% 2-year survival, respectively), stronger expansion in CD8+ ...

4. ecancer.org ecancer.org/en/news/26726-modified-personalised-cancer-vaccine-generates-powerful-immune-response

Modified personalised cancer vaccine generates powerful ... NeoVax includes personalised neoantigens, which are protein fragments that appear on an individual patient's cancer cells and not on normal ...

5. oncodaily.com oncodaily.com/oncolibrary/immunotherapy-success-rate-for-ovarian-cancer

Immunotherapy Success Rate for Ovarian Cancer Overall, single-agent checkpoint inhibitors achieve response rates between 8% and 15%, with a subset reaching up to 30% in dual-blockade therapy ...

6. dana-farber.org dana-farber.org/clinical-trials/18-318

Open-label, Phase I study of NeoVax with Nivolumab in ... This research study is evaluating a new type of vaccine called "Personalized NeoAntigen Cancer Vaccine" in combination with Nivolumab (Opdivo®) for ovarian ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ajco.70006

Personalized Cancer Vaccines in the Clinical Trial Pipeline After a median follow-up of 36 months, the recurrence-free survival rate in the vaccinated cohort was 87.5% (95% CI: 72.7%–100%) [14].

8. clin.larvol.com clin.larvol.com/trial-detail/NCT04024878

NeoVax With Nivolumab in Patients With Ovarian Cancer Outcome Measure, Time Frame ; Objective Response Rate, 2 years ; Duration of Response, 2 years ; Progression Free Survival, 2 Years ; Overall Survival, 2 years ...