What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy and immunotherapy, have a range of side effects. Chemotherapy often leads to nausea, fatigue, hair loss, and increased risk of infection due to lowered blood cell counts. Immunotherapy, including treatments like checkpoint inhibitors and personalized vaccines, can cause immune-related adverse events such as skin rashes, colitis, pneumonitis, and endocrinopathies. These treatments aim to stimulate the immune system to target cancer cells but can also lead to inflammation and autoimmune reactions in various organs.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of ovarian cancer, particularly those that stimulate the immune system to target tumor-specific antigens. One notable approval is pembrolizumab (Keytruda), a PD-1 inhibitor, which has shown efficacy in treating advanced ovarian cancer with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). Another approved drug is nivolumab (Opdivo), which is also a PD-1 inhibitor and has been used in various clinical trials for ovarian cancer. These treatments are similar to the Personalized NeoAntigen Cancer Vaccine as they both aim to enhance the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives for ovarian cancer treatment in 2024 include: 1) Nivolumab (Opdivo®) combined with other immunotherapies or targeted therapies, 2) Dostarlimab, an anti-PD-1 monoclonal antibody, which has shown clinical activity in advanced endometrial cancer and may be applicable to ovarian cancer, 3) Lenvatinib plus Pembrolizumab, a combination that has demonstrated efficacy in advanced endometrial cancer and could be explored for ovarian cancer, and 4) CAR-T cell therapy, which is being investigated for various solid tumors including ovarian cancer.

← Back to Search

Cancer Vaccine

NeoVax + Nivolumab for Ovarian Cancer

Phase 1

Waitlist Available

Led By Panagiotis Konstantinopoulos, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Group (ECOG) performance status ≤2

Age ≥18 years

Must not have

Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric illness

Major surgery within 4 weeks prior to initiation of vaccination and/or incomplete recovery from surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever or chills, fatigue, potential organ inflammation from Nivolumab, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have HIV, chronic hepatitis B or C, or any life-threatening illness unrelated to my cancer.

Select...

I haven't had major surgery or I've fully recovered from one in the last 4 weeks.

Select...

I do not have any uncontrolled illnesses.

Select...

My cancer got worse after 3 or 4 rounds of platinum-based chemotherapy.

Select...

I have previously received immunotherapy with specific drugs.

Select...

I have cancer that has spread to my brain or its coverings.

Select...

My cancer is either mucinous or considered low grade.

Select...

My ovarian tumor is non-epithelial or has low malignant potential.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall incidence of treatment-emergent AEs, SAEs, AEs of at least Grade 3 severity, related AEs, and AEs leading to withdrawal of treatment will be described

Percentage of patients pre-srceened who have enough neoantigens for generation of the vaccine, are not platinum refractory, and who initiate vaccination

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stanfard Platinum with Surgical or Core Needle BiopsyExperimental Treatment3 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 PlatinumExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include surgery, chemotherapy, and immunotherapy. Surgery aims to remove as much of the tumor as possible, which is crucial for improving prognosis. Chemotherapy, often using platinum-based drugs like carboplatin and paclitaxel, works by killing rapidly dividing cancer cells. Immunotherapy, including treatments like the Personalized NeoAntigen Cancer Vaccine, stimulates the patient's immune system to recognize and attack tumor-specific antigens. This is particularly important for ovarian cancer patients as it offers a targeted approach that can potentially lead to better outcomes and fewer side effects compared to traditional therapies.