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Nivolumab for Rhabdomyosarcoma

Children's National Hospital, Washington, United States
Rhabdomyosarcoma+9 More ConditionsNivolumab - Drug
Eligibility
1 - 39
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether a combination of two immunotherapy drugs, nivolumab and ipilimumab, can help to shrink solid tumors in children and young adults.

Eligible Conditions
  • Rhabdomyosarcoma
  • Ewing Sarcoma
  • Relapsed Pediatric Solid Tumors
  • Melanoma
  • Hepatoblastoma
  • Refractory Pediatric Solid Tumors
  • Neuroblastoma
  • Liver Cancer
  • Osteosarcoma
  • Wilms Tumor

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Nivolumab
1
Ipilimumab
1
CLR 131

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 12 months

12 months
Biomarkers of response to checkpoint inhibition (number/activity of immune cells, cytokines, chemokines, C-reactive protein) will be measured in peripheral blood by flow cytometry at baseline and throughout study
Disease response in rare tumors (non-statistical cohort) measured with consistent imaging utilizing the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)
Disease response measured with consistent imaging utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Health outcomes as assessed by the PROMIS® Pediatric Scale v1.0 Global Health 7+2 scores at baseline, prior to start of each cycle, and last trial visit
Health outcomes as assessed by the Parent Proxy Scale v1.0 Global Health 7+2 at baseline, prior to start of each cycle, and last trial visit
Incidence and severity of study treatment-related adverse events measured by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Nivolumab
1
Ipilimumab
1
CLR 131

Side Effects for

Investigator Choice of Chemotherapy
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%Neutropenia
21%Pyrexia
19%Hypomagnesaemia
19%Headache
18%Arthralgia
16%Asthenia
16%Dizziness
16%Neutrophil count decreased
15%Thrombocytopenia
15%Insomnia
14%Weight decreased
14%Hyponatraemia
14%Rash
14%Platelet count decreased
13%Blood creatinine increased
13%White blood cell count decreased
12%Pain in extremity
12%Pruritus
12%Hypokalaemia
12%Abdominal pain
11%Alanine aminotransferase increased
11%Aspartate aminotransferase increased
11%Myalgia
10%Pneumonia
10%Muscular weakness
10%Productive cough
10%Alopecia
10%Dry skin
10%Chest pain
10%Hypoalbuminaemia
10%Dysgeusia
9%Abdominal pain upper
9%Mucosal inflammation
9%Hypothyroidism
9%Upper respiratory tract infection
9%Peripheral sensory neuropathy
8%Lacrimation increased
8%Non-cardiac chest pain
8%Nasopharyngitis
8%Dysphonia
8%Epistaxis
8%Haemoptysis
8%Stomatitis
7%Anxiety
7%Bronchitis
7%Hypertension
7%Hyperkalaemia
7%Dehydration
7%Chills
7%Blood alkaline phosphatase increased
7%Hyperglycaemia
7%Lymphocyte count decreased
6%Oropharyngeal pain
6%Pneumonitis
6%Pleural effusion
6%Neuropathy peripheral
6%Hypophosphataemia
6%Leukopenia
5%Hypotension
5%Urinary tract infection
5%Dry mouth
5%Muscle spasms
5%Pain
5%Gamma-glutamyltransferase increased
5%Malaise
5%Depression
5%Rash maculo-papular
5%Dyspepsia
5%Musculoskeletal chest pain
4%Fall
4%Pulmonary embolism
3%Myocardial infarction
3%Metastases to central nervous system
3%Musculoskeletal pain
3%Chronic obstructive pulmonary disease
3%Febrile neutropenia
2%Adrenal insufficiency
2%Atrial fibrillation
2%Sepsis
2%Malignant pleural effusion
2%Embolism
2%Cardiac failure
2%General physical health deterioration
1%Pancytopenia
1%Lung cancer metastatic
1%Small intestinal haemorrhage
1%Neoplasm progression
1%Gastrointestinal haemorrhage
1%Colitis
1%Appendicitis
1%Respiratory tract infection
1%Bone pain
1%Ataxia
1%Syncope
1%Bronchial obstruction
1%Pneumothorax
1%Circulatory collapse
1%Superior vena cava syndrome
1%Respiratory failure
1%Seizure
1%Atrial flutter
1%Pericardial effusion
1%Ileus
1%Small intestinal obstruction
1%Performance status decreased
1%Skin infection
1%Femur fracture
1%Hypercalcaemia
1%Cancer pain
1%Pericardial effusion malignant
1%Confusional state
1%Tumour pain
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the Investigator Choice of Chemotherapy ARM group. Side effects include: Nausea with 57%, Anaemia with 54%, Fatigue with 51%, Decreased appetite with 39%, Malignant neoplasm progression with 36%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

All patients
1 of 1

Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

All patientsExperimental Group · 3 Interventions: Cryoablation Therapy, Ipilimumab, Nivolumab · Intervention Types: Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3280
Nivolumab
2014
Completed Phase 3
~4460

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
195 Previous Clinical Trials
206,465 Total Patients Enrolled
2 Trials studying Rhabdomyosarcoma
3,414 Patients Enrolled for Rhabdomyosarcoma
Bristol-Myers SquibbIndustry Sponsor
2,537 Previous Clinical Trials
4,019,220 Total Patients Enrolled
2 Trials studying Rhabdomyosarcoma
381 Patients Enrolled for Rhabdomyosarcoma
Marie Nelson, MDPrincipal InvestigatorChildren's National Research Institute

Eligibility Criteria

Age 1 - 39 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your cancer has come back or has not responded to initial treatments that were intended to cure it. There are no other treatments available that could potentially cure your cancer.
There is no limit on the number of chemotherapy treatments you have had before joining the study.

Who else is applying?

What state do they live in?
Minnesota100.0%
What site did they apply to?
Children's National Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

Who is eligible to join this research project?

"This clinical trial is accepting 42 participants suffering from rhabdomyosarcoma, ranging in age between 1 and 39. Eligibility criteria includes the following: a Karnofsky score of at least 50% for those 16 or older, Lansky performance score of 60% or higher for minors under 16, full recovery from any prior chemotherapy treatments at least 21 days before study entry, two measurable/evaluable solid target lesions upon evaluation, one tumor available to receive cryoablation therapy and consent from either patient (if above legal age) or guardian/parent. Furthermore, histologically confirmed osteosarcoma, E" - Anonymous Online Contributor

Unverified Answer

What objectives are the scientists hoping to accomplish through this trial?

"This medical study's primary aim is to assess the occurrence and magnitude of treatment-related side effects using CTCAE v. 5 over a period of 12 months. Additionally, biomarkers associated with checkpoint inhibition will be observed in patient blood via flow cytometry at baseline and during the trial, alongside PROMIS® Pediatric Scale v1.0 Global Health 7+2 scores for health outcomes pre-cycle start and last visit, as well as Parent Proxy Scale v1.0 Global Health 7+2 ratings at all points mentioned previously." - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration officially certified Nivolumab for public use?

"Nivolumab's safety is rated as a 2 by our team at Power due to the fact that this Phase 2 trial has yielded data affirming it protection but not its efficacy." - Anonymous Online Contributor

Unverified Answer

Is it still possible to enroll in this clinical research project?

"According to clinicialtrials.gov, this clinical trial has been ongoing since February 18th 2022 and is actively searching for participants. The study was last updated on March 21st of the same year." - Anonymous Online Contributor

Unverified Answer

Does this exploration include geriatric participants?

"In order to be considered for this investigation, the patient must be below 40 years old. Currently, there are 575 studies accepting minors under 18 and 3327 studies enrolling seniors above 65." - Anonymous Online Contributor

Unverified Answer

How many participants have been enrolled in this experiment?

"Indeed, data from clinicaltrials.gov reveals that this experiment is currently recruiting patients. Initially released on February 18th 2022 and most recently updated on March 21st 2022, the study requires 42 participants to be recruited across 1 location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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