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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Childhood Cancers

Phase 2
Recruiting
Led By Suzanne Forrest, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have tumor assessment at original diagnosis or relapse showing specific molecular and immunohistochemical characteristics
Participants must have relapsed or refractory disease with no standard treatment options available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is studying two immunotherapy drugs as a possible treatment for a certain type of tumor.

Who is the study for?
This trial is for children and young adults with specific INI1-negative tumors, including kidney tumors and various sarcomas. Participants must have relapsed or refractory disease without standard treatment options, measurable disease, good performance status, recovered from prior treatments' effects, adequate organ function, and no recent vaccines.Check my eligibility
What is being tested?
The study tests the combination of two immunotherapy drugs: Nivolumab and Ipilimumab. These are given together to see if they can effectively treat certain aggressive cancers that lack a protein called INI1.See study design
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in organs like the lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), digestive tract symptoms (colitis), fatigue, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor has specific genetic and protein markers.
Select...
My condition has returned or didn't respond to treatment, and no standard treatments are available.
Select...
My cancer type was confirmed through a biopsy at diagnosis or relapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Objective Overall Response Rate (Stratum 1)
Objective Overall Response Rate (Stratum 2)
Secondary outcome measures
Disease control rate at 12 months
Occurrence of toxicities (Grade 3-5 per CTCAE)
Overall survival (OS)
+1 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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
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%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
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: Solid Tumor (Stratum 1)Experimental Treatment2 Interventions
Patients will receive combination therapy with nivolumab at a predetermined dose and ipilimumab at a predetermined dose day 1 of a 21-day cycle for 4 cycles Starting with cycle 5, patients will receive nivolumab monotherapy at a predetermined dose on day 1 and day 15 of a 28-day cycle Patients with INI1-negative relapsed or refractory extracranial solid tumors
Group II: CNS (Stratum 2)Experimental Treatment2 Interventions
Patients will receive combination therapy with nivolumab at a predetermined dose and ipilimumab at a predetermined dose day 1 of a 21-day cycle for 4 cycles Starting with cycle 5, patients will receive nivolumab monotherapy at a predetermined dose on day 1 and day 15 of a 28-day cycle Patients with INI1-negative relapsed or refractory CNS tumors
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?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,935 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,525 Total Patients Enrolled
Suzanne Forrest, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04416568 — Phase 2
Malignant Rhabdoid Tumor Research Study Groups: Solid Tumor (Stratum 1), CNS (Stratum 2)
Malignant Rhabdoid Tumor Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04416568 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04416568 — Phase 2
Malignant Rhabdoid Tumor Patient Testimony for trial: Trial Name: NCT04416568 — Phase 2

Frequently Asked Questions

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

What other exploratory investigations have been conducted concerning Nivolumab?

"Nivolumab's clinical trials began in 2009 at Texas Children's Hospital and thus far there are 365 concluded studies. Additionally, 765 more research projects utilizing this medication as a treatment option are actively enrolling patients with many based out of Houston, TX."

Answered by AI

Is enrollment for this clinical research still available to the public?

"This clinical trial is in the process of recruiting patients, as indicated on clinicaltrials.gov. It first appeared online on August 14th 2020 and was modified most recently on November 21st 2022."

Answered by AI

What maladies has Nivolumab been demonstrated to assuage?

"Nivolumab is a potent drug often used to combat conditions previously treated with anti-angiogenic therapy. It has also proven effective in treating malignant neoplasms, advanced melanoma, and squamous cell carcinoma."

Answered by AI

Has Nivolumab been given the go-ahead by government regulators?

"As it is only a phase 2 trial, there has been enough preliminary data to prove Nivolumab's safety and thus warrant a score of 2. However, efficacy needs to be further evaluated before assigning higher marks."

Answered by AI

How many individuals have been enrolled in this research endeavor?

"The current clinical trial requires 45 qualified individuals to be enrolled. Participants can join from either the Children's Healthcare of Atlanta-Scottish Rite in Houston, Texas or Texas Children's Hospital in Boston, Massachusetts."

Answered by AI

What primary goals is this trial attempting to achieve?

"This investigation, which will span approximately 12 months, aims to determine the Objective Overall Response Rate (Stratum 1). Secondary research objectives include quantifying Disease Control Rates at Month Twelve, assessing overall survival from recruitment and calculating progression-free survival."

Answered by AI

Which Canadian facilities are presently overseeing this research trial?

"This study is in progress at 9 sites, with the most convenient locations being Houston, Boston and Philadelphia. To ease travel requirement if you take part, it's best to select a nearby site."

Answered by AI

Is geriatric participation permitted in this trial?

"This trial is specifically seeking participants aged 6 Months to 40. On this platform, there are 487 trials for minors and 3414 studies that look at senior citizens."

Answered by AI

Is it possible for me to participate in this clinical research?

"This clinical research is looking for 45 individuals between 6 months and 40 years old that have been diagnosed with cancer. To be eligible, patients must fall into either Stratum 1 or 2 as well as meet additional criteria such as having a confirmed loss of INI1 by immunohistochemistry OR molecular confirmation of tumor bi-allelic SMARCB1 (INI1) loss or mutation when INI1 IHC is equivocal or unavailable."

Answered by AI

Who else is applying?

What site did they apply to?
UCSF Benioff Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I hope thus clinical trial help me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers
Suzanne Forrest, MD 2020. "Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04416568.
All > Kidney Cancer > Chordoma
~5 spots leftby Oct 2024
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