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Checkpoint Inhibitor

Nivolumab After Bone Marrow Transplant for Sarcoma

Q: Is it feasible for me to join this clinical trial?

<p>This trial is seeking 39 <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a>-affected individuals between 12 months and 40 years of age. The following prerequisites must be fulfilled: A Karnofsky score ≥ 50 for subjects over 16, a Lansky rating ≥ 60 for those below 16, full recovery from prior bone marrow transplants' toxic effects, allowance to collect baseline tumor biopsies or archival material if not feasible, consenting to non-significant risk procedures related to diagnosing immune system toxicity/GVHD (such as collecting tissue samples).</p>

Phase 1 & 2

Recruiting

Led By Nicolas Llosa, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 12 months and ≤ 50 years of age at the time of study enrollment

Patients with histologically confirmed solid tumors with an estimated poor long term survival

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing if the investigational drug Nivolumab is safe to take after a "half-matched" bone marrow transplant, and if it helps prevent or delay relapse or progression of sarcomas.

Who is the study for?

This trial is for children and adults aged between 1 to 50 years with sarcoma who have had a 'half-matched' bone marrow transplant. It's suitable for those at high risk of their cancer returning or who have already experienced a relapse. Participants must be in good health post-transplant, able to undergo biopsies, and not pregnant or breastfeeding. They should also agree to use contraception and not have severe graft-versus-host disease or uncontrolled infections.Check my eligibility

What is being tested?

The trial is testing Nivolumab, an investigational drug, after a haploidentical bone marrow transplant (BMT) in patients with sarcomas. The goal is to see if Nivolumab can safely prevent or delay the cancer from coming back while monitoring how it affects the blood and tumors.See study design

What are the potential side effects?

Nivolumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), digestive tract symptoms, liver inflammation, lung issues like pneumonitis, kidney problems including nephritis and renal dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 months and 50 years old.

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My solid tumor cancer is expected to shorten my life significantly.

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I am mostly able to care for myself, but may need occasional help.

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I have had a specific type of bone marrow transplant from a half-matched donor.

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My blood tests show normal white blood cell and platelet counts.

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My liver functions, including bilirubin and ALT levels, are within normal ranges.

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My kidney function, measured by creatinine clearance or GFR, is adequate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Adverse events attributed to Nivolumab for patients enrolled in this study

Secondary outcome measures

Overall survival

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

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Hypertension

Bronchitis

Dehydration

Hyperglycaemia

Hyperkalaemia

Blood alkaline phosphatase increased

Chills

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Syncope

Cancer pain

Neoplasm progression

Pneumothorax

Atrial flutter

Bone pain

Pericardial effusion malignant

Circulatory collapse

Confusional state

Hypercalcaemia

Femur fracture

Bronchial obstruction

Superior vena cava syndrome

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: NivolumabExperimental Treatment1 Intervention

Adults: 240 mg IV over 30 minutes every 2 weeks OR 480 mg IV over 30 minutes every 4 weeks. Children and Adolescents weighing 40 kg or more: 240 mg IV over 30 minutes every 2 weeks OR 480 mg IV over 30 minutes every 4 weeks. Children and Adolescents weighing less than 40 kg: 3 mg/kg IV over 30 minutes every 2 weeks.A maximum of 24 cycles will be given on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,025 Total Patients Enrolled

20 Trials studying Sarcoma

1,827 Patients Enrolled for Sarcoma

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,881 Total Patients Enrolled

14 Trials studying Sarcoma

267 Patients Enrolled for Sarcoma

Nicolas Llosa, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03465592 — Phase 1 & 2

Sarcoma Research Study Groups: Nivolumab

Sarcoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03465592 — Phase 1 & 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03465592 — Phase 1 & 2

Frequently Asked Questions

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

Is it feasible for me to join this clinical trial?

"This trial is seeking 39 sarcoma-affected individuals between 12 months and 40 years of age. The following prerequisites must be fulfilled: A Karnofsky score ≥ 50 for subjects over 16, a Lansky rating ≥ 60 for those below 16, full recovery from prior bone marrow transplants' toxic effects, allowance to collect baseline tumor biopsies or archival material if not feasible, consenting to non-significant risk procedures related to diagnosing immune system toxicity/GVHD (such as collecting tissue samples)."

Answered by AI

Are there multiple sites in this city that are participating in the research?

"This clinical trial can be accessed at Albert Einstein College of Medicine, Children's Hospital at Montefiore in Bronx, Johns Hopkins All Children's Hospital in Saint Petersburg, and New york Medical Center/ Maria Fareri Children's Hospital in Valhalla. Additional sites are available as well."

Answered by AI

Are any new participants being recruited for this experiment?

"Affirmative. Data hosted on clinicaltrials.gov corroborates that this study is currently receiving applications for participation, which was first announced on May 1st 2018 and edited lastly on June 23rd 2022. The trial requires 39 volunteers from 4 different sites to be enrolled in the experiment."

Answered by AI

Are there any other scientific investigations involving Nivolumab that have been conducted?

"Currently, there are 717 ongoing medical studies for Nivolumab with 82 of them at Phase 3. Most notably, Basel BE has a substantial number of trials in progress; however, across the world over 40281 different sites have launched clinical investigations surrounding this drug."

Answered by AI

Is this an unprecedented medical experiment?

"According to the latest figures, Nivolumab is being evaluated in 717 different clinical trials across 49 countries and 2356 cities. The initial trial for this medication was launched by Ono Pharmaceutical Co. Ltd., back in 2012 and involved 659 research subjects; since then there have been 252 other studies that have reached completion stages."

Answered by AI

Is the age range for this trial inclusive of individuals over 35 years old?

"This research projects calls for participants ages between 12 Months and 40."

Answered by AI

To which conditions is Nivolumab most routinely prescribed?

"Nivolumab is a common treatment for malignant tumours and can also be utilized to address unresectable melanoma, esophageal adenocarcinoma, as well as squamous cell carcinomas."

Answered by AI

How many individuals have been accepted to participate in this experiment?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this study, which was initially shared on May 1st 2018, is actively recruiting volunteers. Approximately 39 individuals need to be recruited from 4 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma

2018. "Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03465592.

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