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

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 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.

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

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 • 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%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

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%

Alopecia

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Dry skin

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Nasopharyngitis

Lacrimation increased

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hyperkalaemia

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Pneumothorax

Atrial flutter

Bone pain

Small intestinal haemorrhage

Bronchial obstruction

Femur fracture

Syncope

Hypercalcaemia

Pericardial effusion malignant

Confusional state

Cancer pain

Neoplasm progression

Circulatory collapse

Superior vena cava syndrome

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

~2610

Nivolumab

2014

Completed Phase 3

~4750

0 / 4Eligibility 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.