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Checkpoint Inhibitor

Nivolumab for Uterine Cancer

Phase 2

Waitlist Available

Led By Claire Friedman, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of metastatic or recurrent uterine cancer by Memorial Sloan Kettering Cancer Center

One or more prior lines of cytotoxic treatment for advanced disease

Must not have

Disease eligible for potentially curative treatment with standard chemotherapy, surgical resection, or chemoradiotherapy

Known or suspected autoimmune disease, except for specific conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 weeks

Awards & highlights

Summary

This trial is testing the safety of nivolumab in people with gynecologic cancer. They want to see what effects, if any, nivolumab has on patients and their cancer.

Who is the study for?

This trial is for women over 18 with certain types of uterine cancer, including endometrial carcinoma and sarcoma, who have tried at least one other treatment. They must be in good physical condition (ECOG 0-1), not pregnant, willing to use contraception, and without serious medical issues or active infections that could worsen with the trial's therapy.Check my eligibility

What is being tested?

The study is testing Nivolumab's safety and its effects on gynecologic cancers. It aims to understand both positive and negative outcomes for patients using this drug. Participants will receive Nivolumab to see how it affects their specific type of uterine cancer.See study design

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid dysfunction), digestive tract symptoms (like colitis), liver inflammation, tiredness, feverish sensations or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My uterine cancer diagnosis was confirmed by Memorial Sloan Kettering Cancer Center.

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I have received chemotherapy for my advanced disease before.

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My tumor is highly mutated.

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My kidney function is within the required range.

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I can provide previous cancer tissue samples or am willing to have a new biopsy.

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My cancer has not spread to my brain.

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I am a woman aged 18 or older.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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My condition may be treatable with standard methods like chemotherapy, surgery, or chemoradiotherapy.

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I have an autoimmune disease, but it's not one of the exceptions listed.

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I have previously received treatments targeting my immune system.

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I do not have any serious uncontrolled illnesses or active infections.

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I am on systemic steroids or immunosuppressants.

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I have not had a bowel blockage, uncontrollable fluid in my abdomen, or a tear in my intestines in the last 3 months.

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I am allergic to nivolumab or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival

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%

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%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Hypothyroidism

Abdominal pain upper

Upper respiratory tract infection

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Hyperkalaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Dry mouth

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Myocardial infarction

Metastases to central nervous system

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Embolism

Cardiac failure

Malignant pleural effusion

Sepsis

Atrial fibrillation

General physical health deterioration

Adrenal insufficiency

Neoplasm progression

Cancer pain

Confusional state

Circulatory collapse

Bronchial obstruction

Pneumothorax

Atrial flutter

Ileus

Bone pain

Small intestinal haemorrhage

Pericardial effusion

Femur fracture

Pancytopenia

Colitis

Small intestinal obstruction

Hypercalcaemia

Syncope

Pericardial effusion malignant

Superior vena cava syndrome

Gastrointestinal haemorrhage

Lung cancer metastatic

Performance status decreased

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

1Treatment groups

Experimental Treatment

Group I: NivolumabExperimental Treatment1 Intervention

Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4740

0 / 15Eligibility criteria met