Nivolumab for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Endometrial Cancer+6 MoreNivolumab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Endometrial Cancer
  • Uterine Cancer
  • Carcinosarcoma
  • Undifferentiated Sarcoma
  • Endometrial Stromal Sarcoma
  • Clear Cell Carcinoma
  • Leiomyosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: at 24 weeks

at 24 weeks
Progression-Free Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

1 Treatment Group

Nivolumab
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Nivolumab
Drug
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 24 weeks

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,503 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,536 Patients Enrolled for Endometrial Cancer
Bristol-Myers SquibbIndustry Sponsor
2,501 Previous Clinical Trials
3,928,199 Total Patients Enrolled
5 Trials studying Endometrial Cancer
858 Patients Enrolled for Endometrial Cancer
Claire Friedman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have total bilirubin ≤ 1.5 x ULN.
You have a tumor that is MSI-high, or MMR-deficient, or hypermutated.
You have had one or more lines of cytotoxic treatment for advanced disease.
You have measurable disease by RECIST 1.1 criteria.
You have a serum creatinine of ≤ 1.