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Checkpoint Inhibitor
Nivolumab +/− Ipilimumab for Endometrial Cancer
Phase 2
Recruiting
Led By Haider S Mahdi
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
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months after randomization
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a combination of two immunotherapy drugs is better than one of those drugs alone at shrinking tumors in patients with a certain type of endometrial cancer.
Who is the study for?
This trial is for adults over 18 with recurrent endometrial cancer that has a deficient mismatch repair system. Eligible participants may have had prior treatments but must be in good health with stable vital signs and organ function. Those with certain autoimmune diseases, severe allergies to the drugs being tested, or who are pregnant are excluded.
What is being tested?
The study is testing if combining two immune system-boosting drugs, nivolumab and ipilimumab, can better shrink tumors compared to nivolumab alone in patients whose endometrial cancer has returned and shows DNA repair deficiencies.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs like the liver or intestines, skin rashes, hormone gland problems (like thyroiditis), fatigue, infusion reactions similar to allergic responses, and possibly worsening of pre-existing autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have chronic hepatitis B but it's under control with treatment.
Select...
I have recovered from recent surgery or cancer treatments, and it's been over 4 weeks since my last major surgery.
Select...
My endometrial cancer is due to a faulty DNA repair system.
Select...
My endometrial cancer has come back and can be detected.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to certain drugs similar to nivolumab or ipilimumab.
Select...
I do not have an active or history of severe autoimmune disease.
Select...
I have not had treatments targeting immune system checkpoints.
Select...
I stopped immunotherapy due to severe side effects.
Select...
I have been diagnosed with endometrial serous carcinoma or carcinosarcoma.
Select...
I do not have any severe ongoing illnesses that could interfere with the study.
Select...
I have received immunotherapy treatments.
Select...
I am not pregnant and not nursing, or I am willing to stop nursing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months after randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Incidence of adverse events
Objective tumor response (ORR)
Overall survival (OS)
+1 moreSide effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
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
Active Control
Group I: Arm I (nivolumab and ipilimumab)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or CR. Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR.
MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity.
Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.
Group II: Arm II (nivolumab)Active Control4 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR.
MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity.
Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Ipilimumab
2014
Completed Phase 3
~3140
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,248 Total Patients Enrolled
NRG OncologyOTHER
237 Previous Clinical Trials
102,684 Total Patients Enrolled
Haider S MahdiPrincipal InvestigatorNRG Oncology
3 Previous Clinical Trials
136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have rheumatoid arthritis, Sjogren's syndrome, or psoriasis, it should be controlled with topical medication. If you have certain antibodies in your blood, your doctor will check if your organs are affected before you can join the trial.I have had 1 or 2 treatments for my condition before.I am allergic to certain drugs similar to nivolumab or ipilimumab.I have chronic hepatitis B but it's under control with treatment.I have recovered from recent surgery or cancer treatments, and it's been over 4 weeks since my last major surgery.My oxygen levels are generally good, as measured by a pulse oximeter.I have not had treatments targeting immune system checkpoints.I am HIV positive, on treatment, and my viral load is undetectable.My heart function is good and my QTc interval is less than 450 msec.I have vitiligo or a hormone deficiency like thyroiditis that is under control with medication.My endometrial cancer is due to a faulty DNA repair system.Your platelet count is at least 100,000 per microliter.I stopped immunotherapy due to severe side effects.You have enough infection-fighting white blood cells in your body.My thyroid function is normal, or I am on treatment to keep it normal.My brain cancer has not worsened after treatment and I've been off steroids for over a month.I have been diagnosed with endometrial serous carcinoma or carcinosarcoma.Your bilirubin level in your blood should be within a certain range, unless you have a condition called Gilbert's disease.I do not have any severe ongoing illnesses that could interfere with the study.Your creatinine level is not more than 1.5 times the upper limit of normal.I am on low-dose steroids for replacement, not exceeding 10mg of prednisone or its equivalent.I do not have an active or history of severe autoimmune disease.I can take care of myself and am up and about more than half of my waking hours.Your AST and ALT levels are not more than 3 times the upper limit of normal.My endometrial cancer has come back and can be detected.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am 18 years old or older.I have received immunotherapy treatments.I am not pregnant and not nursing, or I am willing to stop nursing.I have another cancer type, but it won't affect this trial's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab and ipilimumab)
- Group 2: Arm II (nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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