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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
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

Study 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.Check my eligibility
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.See study design
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 below
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I can take care of myself and am up and about more than half of my waking hours.
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I have chronic hepatitis B but it's under control with treatment.
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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.
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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.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 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 (PFS)
Secondary outcome measures
Incidence of adverse events
Objective tumor response (ORR)
Overall survival (OS)
+1 more

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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
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%
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
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

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. Patients also undergo a collection of blood and tissue samples throughout the trial and CT scan and/or MRI at screening.
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. Patients also undergo a collection of blood and tissue samples throughout the trial and CT scan and/or MRI at screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,764 Total Patients Enrolled
17 Trials studying Endometrial Carcinoma
8,748 Patients Enrolled for Endometrial Carcinoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,762 Total Patients Enrolled
2 Trials studying Endometrial Carcinoma
133 Patients Enrolled for Endometrial Carcinoma
Haider S MahdiPrincipal InvestigatorNRG Oncology
3 Previous Clinical Trials
169 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05112601 — Phase 2
Endometrial Carcinoma Research Study Groups: Arm I (nivolumab and ipilimumab), Arm II (nivolumab)
Endometrial Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05112601 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112601 — Phase 2

Frequently Asked Questions

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

Can new participants still sign up for the trial?

"Affirmative. Clinicaltrials.gov displays that this experiment, which was initially posted on February 7th 2022 and has been recently revised on October 20th 2022, is currently in recruitment mode. 12 individuals must be sourced from 8 sites to complete the trial."

Answered by AI

How many distinct locations are participating in the research?

"8 clinical trial sites are currently participating, including Fred Hutchinson Cancer Research Center in Seattle, University of Iowa/Holden Comprehensive Cancer Centre in Iowa City, and the University of New mexico Cancer Centre in Albuquerque. There are also 5 other institutions involved."

Answered by AI

What medical conditions is Nivolumab normally used to treat?

"Nivolumab is a common anti-angiogenic treatment that can help patients with malignant neoplasms, unresectable melanoma, and squamous cell carcinoma manage their conditions."

Answered by AI

Has the Food and Drug Administration authorized Nivolumab for clinical use?

"We have estimated Nivolumab's safety rating as a 2, considering that it is currently in Phase 2 of the clinical trial process and has generated some evidence for its relative safety yet none regarding efficacy."

Answered by AI

How many participants has this clinical trial recruited thus far?

"A dozen patients, who comply with this trial's entrance qualifications, need to join. The Fred Hutchinson Cancer Research Center in Seattle and the University of Iowa/Holden Comprehensive Cancer Center in Iowa City are two of the many potential locations where participants may enrol."

Answered by AI

What research has been done previously regarding the efficacy of Nivolumab?

"In 2009, Nivolumab was initially explored at Texas Children's Hospital. Since then, 365 trials have been fully completed and 765 more are in progress around the world, with a major concentration of medical studies occurring in Seattle, Washington."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
2022. "Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05112601.
~47 spots leftby Apr 2026
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