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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Uterine Leiomyosarcoma

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
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN/ =< 5 x ULN for subjects with liver metastases
Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uptime from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Metastatic Leiomyosarcoma
  • Leiomyosarcoma
  • Uterine Leiomyosarcoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal. If you have liver metastases, your AST and ALT levels should not be more than 5 times the upper limit of normal.
Select...
Your kidneys are working well enough, with normal levels of creatinine in your blood or a high enough creatinine clearance rate.
Select...
You have been diagnosed with advanced leiomyosarcoma of the uterus (ULMS), which means it has spread to other parts of your body or cannot be surgically removed.
Select...
Your platelet count is greater than or equal to 100,000 per microliter.
Select...
You have a tumor that can be measured and is at least 2 centimeters using standard techniques or 1 centimeter using advanced imaging methods.
Select...
You must have already undergone at least one round of chemotherapy for ULMS, either as a treatment after surgery or for a recurring case.
Select...
You have enough white blood cells called neutrophils in your body, specifically at least 1,500 per microliter of blood.
Select...
Your total bilirubin level cannot be higher than 1.5 times the normal limit, except if you have Gilbert syndrome, in which case it cannot be higher than 3.0 mg/dL.
Select...
You are expected to live for at least 9 more months.

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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
10%
Alopecia
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
9%
Abdominal pain upper
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
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%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Embolism
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Sepsis
2%
Malignant pleural effusion
1%
Pancytopenia
1%
Atrial flutter
1%
Circulatory collapse
1%
Lung cancer metastatic
1%
Cancer pain
1%
Syncope
1%
Pericardial effusion
1%
Colitis
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal haemorrhage
1%
Small intestinal obstruction
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Confusional state
1%
Bronchial obstruction
1%
Pneumothorax
1%
Respiratory tract infection
1%
Respiratory failure
1%
Superior vena cava syndrome
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Ipilimumab
2014
Completed Phase 3
~2690
Nivolumab
2014
Completed Phase 3
~4120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,265,917 Total Patients Enrolled
41 Trials studying Leiomyosarcoma
2,978 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 carcinomas 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 > Osa > Leiomyosarcoma
~2 spots leftby Dec 2024
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