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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Uterine Cancer

Phase 2
Waitlist Available
Led By Suzanne George
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
Patients must have histologically or cytologically confirmed advanced leiomyosarcoma of the uterus (ULMS); advanced ULMS is defined as metastatic ULMS or unresectable primary ULMS
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
Awards & highlights

Study Summary

This trial studies nivolumab and ipilimumab as possible treatments for uterine cancer. Nivolumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Ipilimumab is also a monoclonal antibody. The combination of nivolumab and ipilimumab may work better than nivolumab alone in treating patients with uterine cancer.

Who is the study for?
This trial is for patients with advanced uterine leiomyosarcoma, a type of cancer that has spread and is typically incurable. Participants must have had at least one prior chemotherapy treatment, be in good physical condition (ECOG 0 or 1), and not be pregnant or breastfeeding. They should not have active brain metastases, severe allergies to monoclonal antibodies, HIV/AIDS, hepatitis B/C infection, uncontrolled illnesses, or a history of certain autoimmune diseases.Check my eligibility
What is being tested?
The study tests the effectiveness of Nivolumab alone or combined with Ipilimumab—both are monoclonal antibodies—in treating advanced uterine leiomyosarcoma. The trial aims to see how these treatments affect tumor growth and spread by targeting specific pathways within the body's immune system.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs like the liver or lungs, skin rashes, hormone gland problems (like thyroid issues), intestinal symptoms (like colitis), fatigue, and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a type of uterine cancer that has spread or cannot be surgically removed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have a tumor that can be measured with scans or exams.
Select...
I have had chemotherapy for uterine leiomyosarcoma before.
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
I am not on high-dose steroids or other immune-weakening medicines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Advance Directives
Advance Directives
Secondary outcome measures
Incidence of Toxicity, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Version 5.0 Beginning April 1, 2018) (Cohort A)
Incidence of Toxicity, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Version 5.0 Beginning April 1, 2018) (Cohort B)
PDL1 Status
+2 more
Other outcome measures
PD1 in Infiltrating Lymphocytes
Neoplasms

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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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

2Treatment groups
Experimental Treatment
Group I: Cohort B (nivolumab and Ipilimumab)Experimental Treatment2 Interventions
Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Group II: Cohort A (nivolumab - closed to accrual on 21-Oct-2015)Experimental Treatment2 Interventions
Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,133 Total Patients Enrolled
41 Trials studying Leiomyosarcoma
3,098 Patients Enrolled for Leiomyosarcoma
Suzanne GeorgePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
2 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
41 Patients Enrolled for Leiomyosarcoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02428192 — Phase 2
Leiomyosarcoma Research Study Groups: Cohort A (nivolumab - closed to accrual on 21-Oct-2015), Cohort B (nivolumab and Ipilimumab)
Leiomyosarcoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02428192 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02428192 — Phase 2

Frequently Asked Questions

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

How does Nivolumab compare in terms of safety for human usage?

"Nivolumab was assessed to have a safety rating of 2; this is due to the fact that it has not yet been proven efficacious, but there are some data points which support its relative security."

Answered by AI

Is this research venture currently open for enrollment?

"As per the information on clinicaltrials.gov, this particular trial has ended its recruitment process. It was first advertised on April 22nd 2015 and last updated October 18th 2022; however, 806 other studies are currently looking for patients to enrol in them."

Answered by AI

How many participants is this trial enlisting?

"The recruitment phase for this trial has officially been closed. The posting was first uploaded on April 22nd 2015, with the last update occurring 18th October 2022. For those looking to participate in other studies related Nivolumab and leiomyosarcoma, 41 trials and 765 studies respectively are currently enrolling patients."

Answered by AI

Has Nivolumab been evaluated in any previous research projects?

"As of now, 765 different trials are assessing the efficacy and safety of Nivolumab with 86 at Phase 3. Whilst much research is conducted in Pittsburgh, Pennsylvania there are a vast number of medical centres (42755) running studies for this treatment."

Answered by AI

What health conditions is Nivolumab typically utilized to address?

"Nivolumab is the most commonly utilized therapy for anti-angiogenic conditions. This immunotherapy can also be beneficial with regards to malignant neoplasms, unresectable melanomas, and squamous cell carcinoma."

Answered by AI

What aims are researchers hoping to accomplish with this clinical experiment?

"This trial's primary outcome is to be monitored for up to 100 days and involves determining the Objective Response Per RECIST 1.1 among ULMS patients treated with Nivolumab and Ipilimumab (Cohort B). Secondary objectives include calculating toxicity levels using NCI Common Terminology Criteria, exploring PDL1 status in relation to treatment response through a Fisher's exact test, and examining progression-free survival rate at 12 weeks via an one-sided exact binomial distribution test set at 10% type I error. With 25 participants enrolled, power of overall progression-free rate is estimated at 87%."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
New York
What site did they apply to?
Brigham and Women's Hospital
Dana-Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma
2015. "Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02428192.
All > Womens Health > Leiomyosarcoma
~2 spots leftby Apr 2025
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