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Checkpoint Inhibitor
Nivolumab +/− Ipilimumab for Ovarian Cancer
Phase 2
Waitlist Available
Led By Dimitry Zamarin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Free of active infection requiring antibiotics (except uncomplicated UTI)
Up to three prior cytotoxic regimens for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the duration of time from study entry to time of death or the date of last contact, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing nivolumab with or without ipilimumab to treat ovarian cancer that has not responded to prior treatment or has come back.
Who is the study for?
This trial is for patients with persistent or recurrent ovarian, primary peritoneal, or fallopian tube cancer who've had prior treatment. They should have adequate organ function and no active infections. Excluded are those with HIV not well-managed by HAART, severe allergies to monoclonal antibodies, recent other cancers (except breast cancer within 2 years), brain disease, uncontrolled illnesses, or a history of certain autoimmune diseases.Check my eligibility
What is being tested?
The study tests how effective nivolumab is alone or combined with ipilimumab in treating these cancers. Both drugs are immunotherapies that may boost the body's ability to fight cancer by interfering with tumor growth and spread.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like the liver and intestines, skin issues such as rash and itching, hormone gland problems (like thyroid dysfunction), fatigue, nausea, breathing difficulties due to lung inflammation, and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not currently on antibiotics for an infection, except for a simple UTI.
Select...
I have had up to 3 treatments for ovarian, fallopian tube, or peritoneal cancer.
Select...
My ovarian, fallopian tube, or peritoneal cancer has come back or not gone away and is getting worse.
Select...
I finished my radiation therapy at least 4 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the duration of time from study entry to time of death or the date of last contact, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the duration of time from study entry to time of death or the date of last contact, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Tumor Response
Secondary outcome measures
Duration of Overall Survival (OS)
Incidence of Adverse Events Grade 3 and Above
Progression-free Survival (PFS)
Other outcome measures
Changes in Biomarkers
Markers of "Immunogenicity"
Tumor Cells, Embolic
Side 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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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
Active Control
Group I: Group II (nivolumab, ipilimumab)Experimental Treatment2 Interventions
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for up to 21 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Group I (nivolumab)Active Control1 Intervention
INDUCTION: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive nivolumab IV over 30 minutes every 2 weeks. Treatment repeats every 4 weeks for up to 21 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,053 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,752 Total Patients Enrolled
Dimitry ZamarinPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or breastfeeding.I am not currently on antibiotics for an infection, except for a simple UTI.I have had up to 3 treatments for ovarian, fallopian tube, or peritoneal cancer.I stopped my cancer hormone therapy at least a week ago.I do not have any uncontrolled illnesses or infections.My ovarian, fallopian tube, or peritoneal cancer has come back or not gone away and is getting worse.I finished my radiation therapy at least 4 weeks ago.I have been mostly active and able to care for myself in the last 28 days.I have not had chemotherapy for abdominal or pelvic tumors, except for ovarian, fallopian tube, or primary peritoneal cancer, in the last 3 years.I have had radiation therapy in my abdomen, pelvis, or chest in the last 3 years.I have previously been treated with immune-targeting cancer drugs.I experience significant numbness or pain in my hands or feet.I have not had a stroke, brain tumor, seizures, or similar conditions in the last 6 months.I am HIV positive with unstable treatment, CD4 counts below 350, or a detectable viral load.I have an autoimmune disease that could worsen or needs treatment to suppress my immune system.I have not had any other cancer besides breast cancer in the last 2 years.It has been over 4 weeks since my last major surgery.I stopped my previous cancer treatment at least 4 weeks ago.I have recovered from recent surgery, radiotherapy, or chemotherapy.My thyroid function is normal as of the last 28 days.I have had an organ transplant.My hepatitis infection is not under control according to the study's standards.I haven't had any major stomach or intestine problems in the last 6 months.My cancer returned less than 12 months after my last platinum-based chemotherapy.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I have not had stomach ulcers, severe gut issues, or gallbladder inflammation in the last 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (nivolumab, ipilimumab)
- Group 2: Group I (nivolumab)
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.
Is Nivolumab a novel or previously examined therapeutic agent?
"Nivolumab first made its debut in clinical research at Texas Children's Hospital during the year 2009. To date, 365 trials have been completed with an additional 765 active studies happening as of today--many of which are located in Iowa City, Iowa."
Answered by AI
What are the geographic locations where this trial is being conducted?
"Presently, 100 individuals are being sought for this trial. Specific sites include the University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Prisma Health Cancer Institute - Spartanburg in Boiling Springs, and Mercy Hospital Joplin located in Joplin; other recruiting locations may also exist."
Answered by AI
What medical conditions has Nivolumab been most successful in alleviating?
"In the past, Nivolumab has been successful in treating anti-angiogenic therapy, malignant tumours and cases of unresectable melanoma."
Answered by AI
Are participants still being accepted for this research project?
"This clinical trial has ceased recruitment of new participants, with a first posting date of June 29th 2015 and last update on October 18th 2022. For those looking for similar studies, there are 3375 trials searching for patients with carcinoma and 765 investigations requiring Nivolumab test subjects."
Answered by AI
How many volunteers have been accepted into this clinical experiment?
"As of this moment, recruitment for the trial has been ceased. According to clinicaltrials.gov records, it was posted on June 29th 2015 and last updated October 18th 2022. Presently there are 3375 studies concerning cancer searching for participants as well as 765 trials actively looking for patients taking Nivolumab."
Answered by AI
Has the Food and Drug Administration sanctioned Nivolumab?
"Nivolumab has been assigned a safety score of 2 due to limited clinical data available. This is because it is only in the second phase of trials and there are no efficacy results yet."
Answered by AI
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