What side effects are associated with this type of intervention?

The most common treatments for Fallopian Tube Cancer, particularly those involving immune checkpoint inhibitors like Nivolumab (PD-1 Inhibitor) and Ipilimumab (CTLA-4 Inhibitor), are associated with several side effects. Common adverse effects include fatigue, rash, diarrhea, and pruritus. More severe but less frequent side effects can include pneumonitis, colitis, hepatitis, endocrinopathies (such as hypothyroidism or hyperthyroidism), and nephritis. These side effects arise from the immune system's enhanced activity, which can sometimes target normal tissues in addition to cancer cells.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for cancers similar to Fallopian Tube Cancer, particularly those involving PD-1 and CTLA-4 inhibitors. Nivolumab, a PD-1 inhibitor, and Ipilimumab, a CTLA-4 inhibitor, are being studied for their efficacy in treating persistent or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. These drugs work by enhancing the body's immune response against cancer cells. While specific FDA approvals for Fallopian Tube Cancer may not be detailed, these immunotherapies are part of a broader strategy to treat related gynecologic cancers.

What other types of research exist?

Promising novel alternatives to Nivolumab and Ipilimumab for Fallopian Tube Cancer patients include Pembrolizumab (another PD-1 inhibitor) combined with Lenvatinib (a VEGF receptor inhibitor), which has shown significant improvements in progression-free survival and overall survival in various gynecological cancers. Additionally, ongoing research into other immune checkpoint inhibitors and combination therapies may provide new options.

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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

Must not have

Uncontrolled illness including ongoing or active infection, symptomatic congestive heart failure, and unstable angina pectoris

Received prior chemotherapy for any abdominal or pelvic tumor other than ovarian, fallopian tube, or primary peritoneal cancer within the last three years

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

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.

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.

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 below

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I am not currently on antibiotics for an infection, except for a simple UTI.

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I have had up to 3 treatments for ovarian, fallopian tube, or peritoneal cancer.

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My ovarian, fallopian tube, or peritoneal cancer has come back or not gone away and is getting worse.

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I finished my radiation therapy at least 4 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses or infections.

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I have not had chemotherapy for abdominal or pelvic tumors, except for ovarian, fallopian tube, or primary peritoneal cancer, in the last 3 years.

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I have had radiation therapy in my abdomen, pelvis, or chest in the last 3 years.

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I have not had a stroke, brain tumor, seizures, or similar conditions in the last 6 months.

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I am HIV positive with unstable treatment, CD4 counts below 350, or a detectable viral load.

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I have an autoimmune disease that could worsen or needs treatment to suppress my immune system.

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I have previously been treated with immune-targeting cancer drugs.

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I experience significant numbness or pain in my hands or feet.

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I have had an organ transplant.

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My hepatitis infection is not under control according to the study's standards.

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I haven't had any major stomach or intestine problems in the last 6 months.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I have not had stomach ulcers, severe gut issues, or gallbladder inflammation in the last 2 months.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of time from study entry to time of death or the date of last contact, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Tumor Response

Secondary study objectives

Duration of Overall Survival (OS)

Incidence of Adverse Events Grade 3 and Above

Progression-free Survival (PFS)

Other study objectives

Changes in Biomarkers

Markers of "Immunogenicity"

Tumor Cells, Embolic

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%

Cushingoid

10%

Tinnitus

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

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

~3140

Nivolumab

2014

Completed Phase 3

~5220

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nivolumab and Ipilimumab are immunotherapy agents used in the treatment of Fallopian Tube Cancer. Nivolumab is a PD-1 inhibitor that blocks the PD-1 pathway, enhancing the immune system's ability to attack cancer cells. Ipilimumab is a CTLA-4 inhibitor that promotes a stronger immune response by blocking the CTLA-4 checkpoint protein. These treatments are significant for Fallopian Tube Cancer patients as they leverage the body's immune system to target cancer cells, offering a promising alternative to traditional chemotherapy.

Update on malignant ovarian germ cell tumors.Systemic anti-cancer treatment in malignant ovarian germ cell tumours (MOGCTs): current management and promising approaches.Outcomes of ovarian germ cell tumors: ten years of experience at the Brazilian National Cancer Institute.