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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Ovarian Cancer

Phase 2
Waitlist Available
Led By Don Dizon, MD
Research Sponsored by Don Dizon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a clear cell carcinoma of ovarian, fallopian or primary peritoneal origin must have progressed after at least one prior platinum and taxane based chemotherapy regimen
Patients with extra-renal clear cell cancer (including other GYN) cancers must have progressed after at least one prior regimen for advanced/metastatic disease. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks during treatment then every 12 weeks in follow-up for up to 2 years (once off study) and until progression.
Awards & highlights

Study Summary

This trial is testing whether a new drug can help people with a certain type of ovarian cancer.

Who is the study for?
This trial is for adults with clear cell carcinoma of ovarian, fallopian tube, primary peritoneal, or extra-renal origin who have progressed after prior treatments. They must have good organ function and performance status, no history of certain immune diseases or severe allergies to monoclonal antibodies, not be pregnant or breastfeeding, and agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing the effectiveness of Nivolumab alone or in combination with Ipilimumab in treating clear cell carcinomas. These drugs are designed to help the immune system recognize and attack cancer cells by blocking pathways that cancer uses to hide from immune cells.See study design
What are the potential side effects?
Potential side effects include fatigue, skin reactions, digestive issues like diarrhea or colitis (inflammation of the colon), liver inflammation, hormone gland problems (like thyroid dysfunction), and possible autoimmune reactions where the body attacks its own tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian, fallopian, or peritoneal cancer worsened after platinum and taxane treatment.
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My clear cell cancer has worsened after at least one treatment for its advanced stage.
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My total bilirubin levels are within the normal range, or I have Gilbert's syndrome or liver metastases with specific limits.
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I am using highly effective birth control as a woman able to have children.
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My cancer is a type of clear cell carcinoma and has come back or spread.
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I have at least one cancer lesion that can be measured.
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I have never been treated with anti-PD-1, PD-L1, or CTLA-4 antibodies.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My thyroid function is normal, or controlled with medication.
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I am a man and will use highly effective birth control if I'm sexually active with a woman who can become pregnant.
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My kidney function, measured by creatinine levels or clearance, is within normal limits.
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I am a man and will use birth control for 7 months after treatment if sexually active with a woman who can become pregnant.
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My organ and bone marrow functions are normal.
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I am not able to have children due to menopause or surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks during treatment then every 12 weeks in follow-up for up to 2 years (once off study) and until progression.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks during treatment then every 12 weeks in follow-up for up to 2 years (once off study) and until progression. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who have objective tumor response (complete or partial) by modified RECIST 1.1 in patients with clear cell carcinomas treated with nivolumab or the combination of nivolumab and ipilimumab
Secondary outcome measures
Compare median PFS for patients treated with nivolumab (Arm 1) and the combination of nivolumab and ipilimumab (Arm 2)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
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%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
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%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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

4Treatment groups
Experimental Treatment
Group I: Arm 2 Nivolumab and Ipilimumab OvarianExperimental Treatment2 Interventions
Nivolumab 240 mg every 2 weeks Ipilimumab 1mg/kg day 1 Cycle=6 weeks
Group II: Arm 2 Nivolumab and Ipilimumab Extra-renalExperimental Treatment2 Interventions
Nivolumab 240 mg every 2 weeks Ipilimumab 1mg/kg day 1 Cycle=6 weeks
Group III: Arm 1 Nivolumab OvarianExperimental Treatment1 Intervention
Nivolumab 240 mg Day 1 Cycle = 2 weeks
Group IV: Arm 1 Nivolumab Extra-renalExperimental Treatment1 Intervention
Nivolumab 240 mg Day 1 Cycle = 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandOTHER
107 Previous Clinical Trials
38,464 Total Patients Enrolled
4 Trials studying Ovarian Cancer
615 Patients Enrolled for Ovarian Cancer
Don DizonLead Sponsor
2 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Ovarian Cancer
1 Patients Enrolled for Ovarian Cancer
Brown UniversityLead Sponsor
452 Previous Clinical Trials
562,150 Total Patients Enrolled
1 Trials studying Ovarian Cancer
1 Patients Enrolled for Ovarian Cancer

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03355976 — Phase 2
Ovarian Cancer Research Study Groups: Arm 1 Nivolumab Ovarian, Arm 2 Nivolumab and Ipilimumab Ovarian, Arm 1 Nivolumab Extra-renal, Arm 2 Nivolumab and Ipilimumab Extra-renal
Ovarian Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03355976 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03355976 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications being accepted for this medical trial at present?

"Affirmative. Clinicaltrials.gov has information verifying that this trial is currently recruiting 62 participants from 4 different sites, with the original posting date being April 30th 2018 and most recent update on May 12th 2022."

Answered by AI

What other evidence do we have of Nivolumab's efficacy in clinical settings?

"At the present moment, there are 765 studies involving Nivolumab in progress with 86 of those trials at Phase 3. While Pittsburgh is one hub for these experiments, multiple other locations across 42755 cities are currently conducting research on this drug."

Answered by AI

What diseases have been improved by the use of Nivolumab?

"Nivolumab offers a possible therapeutic option for those with past anti-angiogenic therapy, malignant neoplasms, or inoperable melanoma."

Answered by AI

Has Nivolumab been given clearance by the Food and Drug Administration?

"By our estimation, the safety of Nivolumab has been rated a 2 due to evidence supporting its security but no proof that it is efficacious."

Answered by AI

How many participants have signed up for the trial thus far?

"Affirmative. The info on clinicaltrials.gov indicates that recruitment for this experiment is ongoing and has been since April 30th 2018 when it was first posted and updated most recently on May 12th 2022. 62 patients are required from 4 different medical centres."

Answered by AI
~1 spots leftby Jun 2024