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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
Must not have
Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of day 1 study drug administration
Participants who have had prior therapy with nivolumab or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways
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
No Placebo-Only Group

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.
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.
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 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 kidney function, measured by creatinine levels or clearance, is within normal limits.
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I am not able to have children due to menopause or surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken high-dose steroids or other immune-weakening drugs in the last 14 days.
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I have previously received treatments targeting the immune system for cancer.
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I do not have brain metastases.
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I have HIV/AIDS, am on stable HAART, have CD4 counts > 350, and no detectable viral load.
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I do not have an active autoimmune disease or a history that could affect my organs.
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I have recovered from major side effects of previous treatments.
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I am not planning to receive any other cancer treatments not part of the trial.
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I have moderate to severe numbness, pain, or weakness in my hands or feet.
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I do not have any serious ongoing illnesses that my doctor is currently treating.

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

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

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%
0%
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

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
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Don DizonLead Sponsor
2 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Ovarian Cancer
1 Patients Enrolled for Ovarian Cancer
The Miriam HospitalOTHER
244 Previous Clinical Trials
37,832 Total Patients Enrolled
Women and Infants Hospital of Rhode IslandOTHER
114 Previous Clinical Trials
40,304 Total Patients Enrolled
4 Trials studying Ovarian Cancer
615 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 2 Nivolumab and Ipilimumab Extra-renal, Arm 1 Nivolumab Extra-renal, Arm 2 Nivolumab and Ipilimumab Ovarian, Arm 1 Nivolumab Ovarian
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
~6 spots leftby Nov 2025
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