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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 weeks3 visits

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.

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%

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

0 / 18Eligibility criteria met

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

245 Previous Clinical Trials

37,852 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

Brown UniversityLead Sponsor

466 Previous Clinical Trials

699,034 Total Patients Enrolled

1 Trials studying Ovarian Cancer

1 Patients Enrolled for Ovarian Cancer

Bristol-Myers SquibbIndustry Sponsor

2,696 Previous Clinical Trials

4,099,025 Total Patients Enrolled

11 Trials studying Ovarian Cancer

1,100 Patients Enrolled for Ovarian Cancer

Rhode Island HospitalOTHER

265 Previous Clinical Trials

68,782 Total Patients Enrolled

Don Dizon, MD3.45 ReviewsPrincipal Investigator - Brown University Oncology Research Group (BrUOG) & Lifespan Cancer Institute

Brown University

2 Previous Clinical Trials

104 Total Patients Enrolled

5Patient Review

I absolutely love this doctor! They are so kind and really listen to everything you have to say. They're also very knowledgeable. I really miss them now that they're in Massachusetts.