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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 weeks
Awards & highlights

Study 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.

Timeline

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%
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%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
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
~4750

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,587 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,480 Patients Enrolled for Endometrial Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,479 Total Patients Enrolled
4 Trials studying Endometrial Cancer
385 Patients Enrolled for Endometrial Cancer
Claire Friedman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03241745 — Phase 2
Endometrial Cancer Research Study Groups: Nivolumab
Endometrial Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03241745 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03241745 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary illness that Nivolumab has been proven to help?

"Nivolumab is a standard treatment for malignant neoplasms, and can also help patients with unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

What other scientific papers mention Nivolumab in their research?

"Currently, there are 748 clinical trials underway that involve nivolumab. Of these active studies, 82 have reached Phase 3. The majority of these investigations are based in Basel, BE; however, 40405 locations worldwide are running trials for this treatment."

Answered by AI

How many individuals are being enrolled in this trial?

"Unfortunately, this study is not currently recruiting patients. However, there are 748 other trials for Nivolumab admitting participants and 3233 clinical trials searching for patients with carcinosarcoma."

Answered by AI

Has this kind of clinical trial been done before?

"Nivolumab has been the focus of medical research for over a decade at this point. The first study was completed in 2010 by Medarex and only involved 127 patients. Nivolumab received Phase 1 drug approval after the trial's completion. As of now, there are 748 active studies being conducted across 2349 cities and 50 countries."

Answered by AI

Are we still receiving participants for this trial?

"This study is no longer recruiting patients for participation. It was originally posted on 8/3/2017, and the last update to the listing was on 4/4/2022. There are 3233 other clinical trials actively recruiting patients with carcinosarcoma and 748 studies for Nivolumab that are currently open."

Answered by AI

Is this research project being conducted in several hospitals within the city?

"9 different hospitals are currently enrolling patients for this study. The locations of these 9 centres include Middletown, Uniondale and Basking Ridge as well other cities. It would be sensible to pick the closest location to avoid having to travel long distances."

Answered by AI

Has Nivolumab been cleared by the FDA?

"Nivolumab is still in Phase 2 clinical trials, so there is not yet enough data to support its efficacy. However, the data collected thus far indicates that it may be safe for use, and it received a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab in Selected Uterine Cancer Patients
2017. "A Study of Nivolumab in Selected Uterine Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03241745.
~5 spots leftby Apr 2025
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