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Cancer Vaccine
NeoVax + Nivolumab for Ovarian Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer vaccine in combination with a current immunotherapy drug for ovarian cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
The rates of autoimmune effects
Secondary outcome measures
Duration of Response
Objective Response Rate
Overall Survival
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,951 Total Patients Enrolled
39 Trials studying Ovarian Cancer
4,500 Patients Enrolled for Ovarian Cancer
United States Department of DefenseFED
865 Previous Clinical Trials
327,669 Total Patients Enrolled
6 Trials studying Ovarian Cancer
1,825 Patients Enrolled for Ovarian Cancer
Panagiotis Konstantinopoulos, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 or had an autoimmune disease, with some exceptions.I do not have HIV, chronic hepatitis B or C, or any life-threatening illness unrelated to my cancer.I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.My organs and bone marrow are functioning well.I have had cancer before, but it was either treated or is a certain type.I haven't had major surgery or I've fully recovered from one in the last 4 weeks.I do not have any uncontrolled illnesses.My cancer got worse after 3 or 4 rounds of platinum-based chemotherapy.I have previously received immunotherapy with specific drugs.I have cancer that has spread to my brain or its coverings.I haven't taken steroids or immunosuppressants in the last 14 days.My cancer is either mucinous or considered low grade.You have to have a negative pregnancy test.My ovarian tumor is non-epithelial or has low malignant potential.
Research Study Groups:
This trial has the following groups:- Group 1: Stanfard Platinum
- Group 2: Stanfard Platinum with Surgical or Core Needle Biopsy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on the number of participants in this clinical research?
"Affirmative. Records published on clinicaltrials.gov show that this medical trial, which was initiated on November 20th 2020, is still recruiting participants. Approximately 30 individuals will be sourced from a single site for the experiment's duration."
Answered by AI
What conditions does Nivolumab provide relief for?
"Nivolumab is commonly used to manage malignant neoplasms, and has also demonstrated effectiveness with unresectable melanoma, squamous cell carcinoma, as well as metastatic esophageal adenocarcinoma."
Answered by AI
Is this experiment a pioneering effort in its field?
"Since 2012, when the first pharmaceutical-funded study on nivolumab was carried out involving 659 participants, this drug has been subject to numerous clinical trials. By 2018 it had received its Phase 1 & 2 approval and currently 717 active studies are taking place across multiple cities in 49 countries."
Answered by AI
Has the Food & Drug Administration given its stamp of approval to Nivolumab?
"Since it is a Phase 1 trial, there are only limited data points supporting the safety and efficacy of Nivolumab; thus, our team at Power assigned this medication a rating of 1."
Answered by AI
Have there been other investigations involving Nivolumab?
"Presently, 717 trials are exploring Nivolumab. Of these investigations in progress, 82 have entered Phase 3 of the clinical trial process. Zürich, BE is the site with most research facilities testing this medication; however, there are 40290 other locations running experiments as well."
Answered by AI
Are there any opportunities to participate in this experiment at the present time?
"Affirmative. Clinicaltrials.gov provides evidence that this trial, which was originally posted on November 20th 2020, is presently open for enrollment. The study requires 30 individuals to participate from 1 medical centre."
Answered by AI
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