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Checkpoint Inhibitor

Nivolumab for Bone Sarcoma

Phase 2
Waitlist Available
Led By Sandra P D'Angelo
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is studying nivolumab with or without ipilimumab as a treatment for metastatic or unresectable sarcoma.

Eligible Conditions
  • Bone Sarcoma
  • Soft Tissue Sarcoma
  • Liposarcoma
  • Gastrointestinal Stromal Tumor
  • Pleomorphic Liposarcoma
  • Bone Cancer
  • Sarcoma
  • Pleomorphic Sarcoma
  • Malignant Gastrointestinal Stromal Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Achieved a Confirmed Response
Secondary outcome measures
6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]
6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]
6-Month Clinical Benefit Rate [Initial Cohort]
+4 more
Other outcome measures
Change in Selected Biomarkers Measured in Serial Peripheral Blood
Confirmed Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression
Duration of Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression
+4 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%
Bronchitis
7%
Hypertension
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Cancer pain
1%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
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
Group I: Arm II (nivolumab, ipilimumab)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
Group II: Arm I (nivolumab)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,170 Total Patients Enrolled
Sandra P D'AngeloPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Frequently Asked Questions

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

What is the potential harm associated with Nivolumab?

"Nivolumab's safety is estimated to be a 2 because, while there is data supporting its safety profile, efficacy has not yet been proven in clinical trials."

Answered by AI

How many enrollees are needed for this clinical trial?

"This clinical trial is no longer enrolling patients. The listing for this study was first posted on 7/30/2015 and edited for the last time on 10/18/2022. If you are looking for other studies, 575 trials are currently open to enrollment for pleomorphic liposarcoma and 796 Nivolumab trials are admitting new participants."

Answered by AI

Does Nivolumab have a history of being tested in other medical trials?

"As of now, there are 796 ongoing studies investigating the efficacy of Nivolumab. Of these, 86 have reached Phase 3. The majority of these clinical trials originate from 43300 different locations; however, many of them are based in Pittsburgh, Pennsylvania."

Answered by AI

Are there many research hospitals conducting this trial in Canada?

"There are 100 locations hosting this clinical trial, with each site enrolling patients. For example, Mountain Blue Cancer Care Center in Golden, Mission Cancer and Blood - Laurel in Des Moines, and Cancer Center of Kansas-Manhattan in Manhattan are all participating."

Answered by AI

Are we currently recruiting participants for this trial?

"Data last updated on October 18th, 2022 suggests that this trial is no longer recruiting patients. Although this particular study has completed its search for participants, there are 1,371 other trials with open enrollment at the moment."

Answered by AI

Nivolumab is sometimes used to help treat which conditions?

"Nivolumab is often used to treat patients that have undergone anti-angiogenic therapy. It can also be effective in managing multiple other conditions, such as malignant neoplasms and unresectable melanoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery
2015. "Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02500797.
~17 spots leftby Apr 2025
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