Nivolumab for Metastatic Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Leiomyosarcoma+2 MoreNivolumab - Biological
Eligibility
18+
Female
What conditions do you have?
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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
  • Unresectable Leiomyosarcoma
  • Uterine Leiomyosarcoma

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months

Baseline
Neoplasms
Week 12
Rate of Progression-free Survival (Cohort A)
Month 6
Rate of Progression-free Survival (Cohort B)
Up to 100 days
Advance Directives
Advance Directives
PD1 in Infiltrating Lymphocytes
PDL1 Status
Up to 4 cycles
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)

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

2 Treatment Groups

Cohort B (nivolumab and Ipilimumab)
1 of 2
Cohort A (nivolumab - closed to accrual on 21-Oct-2015)
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Cohort B (nivolumab and Ipilimumab)Experimental Group · 2 Interventions: Ipilimumab, Laboratory Biomarker Analysis · Intervention Types: Biological, Other
Cohort A (nivolumab - closed to accrual on 21-Oct-2015)Experimental Group · 2 Interventions: Nivolumab, Laboratory Biomarker Analysis · Intervention Types: Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,093 Previous Clinical Trials
41,143,300 Total Patients Enrolled
6 Trials studying Metastatic Leiomyosarcoma
464 Patients Enrolled for Metastatic Leiomyosarcoma
Suzanne GeorgePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
2 Previous Clinical Trials
89 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
AST/ALT ratio > 2.5:1 or AST/ALT ratio > 5:1 for subjects with liver metastases.
You have a life expectancy of greater than 9 months.