CLINICAL TRIAL

Nivolumab for Cancer

1 Prior Treatment
Metastatic
Recurrent
Refractory
Recruiting · < 65 · All Sexes · Washington, United States

Neoadjuvant Dual Checkpoint Inhibition and Cryoablation in Relapsed/Refractory Pediatric Solid Tumors

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About the trial for Cancer

Eligible Conditions
Neoplasms · Sarcoma, Ewing · Ewing Sarcoma · Melanoma · Hepatocellular Carcinoma · Osteosarcoma · Neuroblastoma · Wilms Tumor · Relapsed Pediatric Solid Tumors · Rhabdomyosarcoma · Refractory Pediatric Solid Tumors · Hepatoblastoma

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nivolumab
DRUG
Cryoablation Therapy
PROCEDURE
Ipilimumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4470
Ipilimumab
2014
Completed Phase 3
~3350

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Cancer or one of the other 11 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age: >1 year and <40 years at time of enrollment on study.
Diagnosis: histologically confirmed solid tumors (at time of original diagnosis or relapse), including osteosarcoma, Ewing sarcoma family of tumors, and rhabdomyosarcoma for disease-specific arms. For non-statistical cohort, other types of tumors are eligible, including but not limited to melanoma, hepatic tumors, Wilms tumor, neuroblastoma, and non-rhabdomyosarcoma soft tissue sarcomas.
Therapeutic options: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy in past, chemotherapy, or combination of these modalities.
Performance Status: Karnofsky ≥50% for patients >16 years of age and Lansky ≥60% for patients ≤16 years of age. Patients who are unable to walk because of paralysis but are up in a wheelchair, will be considered ambulatory for purpose of assessing performance score.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrolling on this study.
You have received no more than two prior chemotherapy regimens. show original
Myelosuppressive chemotherapy: At least 21 days after last dose of cytotoxic or myelosuppressive chemotherapy and at least 6 weeks after last dose of nitrosurea.
You are informed and understand the risks and benefits of the procedure and the risks and benefits of not performing the procedure show original
You have two or more measurable/evaluable solid target lesions. show original
Patients must have at least one tumor available for cryoablation therapy. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Cancer. Measurement will happen over the course of 12 months.

Incidence and severity of study treatment-related adverse events measured by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5
12 MONTHS
Toxicities will be defined using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.
12 MONTHS
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
12 MONTHS
Each question will be rated from the following: Excellent (5) to Poor (1), Never (5) to Always (1), or Never (1) to Almost Always (5)
12 MONTHS
Disease response in rare tumors (non-statistical cohort) measured with consistent imaging utilizing the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)
12 MONTHS
Patients in the non-statistical cohort will under consistent imaging prior to every odd cycle measured by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
12 MONTHS
Disease response measured with consistent imaging utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
12 MONTHS
Patients will undergo consistent imaging prior to every odd cycle of therapy and utilize the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
12 MONTHS
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
12 MONTHS
Each question will be rated from the following: Excellent (5) to Poor (1), Never (5) to Always (1), or Never (1) to Almost Always (5)
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
12 MONTHS
Peripheral blood will be collected from patients at baseline, following neoadjuvant immunotherapy/prior to cryoablation, and prior to each cycle of immunotherapy.
12 MONTHS

Who is running the study

Principal Investigator
M. N.
Marie Nelson, Oncologist
Children's National Research Institute

Patient Q & A Section

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

How many people get wilms tumor a year in the United States?

Recent findings supports the importance of universal screening and the need for greater clinical work to improve outcomes for the patient in this most common childhood kidney cancer.

Anonymous Patient Answer

Can wilms tumor be cured?

Wilms tumor has been successfully cured in the majority of cases following the use of effective chemotherapy, radiation therapy, and surgery. However, some patients require multiple surgeries.

Anonymous Patient Answer

What are common treatments for wilms tumor?

There are some cases of the Wilms' tumor which are exceedingly indolent. This indolent cases, which constitute 10 to 15% of all cases, are treated with observation of tumor growth. Surgical removal of the primary tumor is typically indicated in these cases, though it is more common to resect the tumor at the time of secondary removal of the kidney. Patients with this indolent presentation should have close surveillance because metastatic progression may occur even after treatment with the watch-and-wait policy and without the use of cytotoxic chemotherapy. In advanced stage cases where the disease is progressing, resectional treatment is indicated and often the tumor cannot be removed as a primary surgical intervention.

Anonymous Patient Answer

What are the signs of wilms tumor?

The presenting signs and symptoms of Wilms tumors, in addition to the age of presentation, are significant because the long-term prognosis is dependent on early detection and complete treatment.

Anonymous Patient Answer

What causes wilms tumor?

The development of an adrenal cortex tumor is determined by a complex mixture of genetic and epigenetic factors. Because the exact mechanisms have yet to be identified, there is no way to prevent or treat this disease before it affects the patient.

Anonymous Patient Answer

What is wilms tumor?

If you want to join a trial to see if you are a good candidate for the treatment of a cancer, Power can help you find recent trials tailored to your condition, treatment, or location.

Anonymous Patient Answer

What does ipilimumab usually treat?

In the clinical trials that we reviewed, patients in the ipilimumab-treated groups had larger tumors, higher pretreatment ESR levels, and more severe symptoms. However, a correlation between tumor size and pretreatment distress was not apparent. Because our patients received a high proportion of their posttreatment distress related to cancer in patients lacking a tumor response, we recommend that patients with tumors receive some pre-treatment distress assessment so that response to therapy does not preclude the patient from considering a full treatment program.

Anonymous Patient Answer

What are the chances of developing wilms tumor?

Results from a recent paper show that a low pretreatment serum alpha-feto protein level predicts the development of Wilms tumor in cases of children with primary renal cell carcinoma.

Anonymous Patient Answer

What is the latest research for wilms tumor?

This research demonstrates the need to make further study of the risk of developing a solid tumor in children that have received one or more rounds of chemotherapy for Wilms tumor. This is in particular, because the patients have a higher risk of developing a second solid tumor and leukemia. However, the use of the Wilms tumor antigen (WT1) as biomarker for pediatric patients with solid tumors needs further study. Findings from a recent study reported in this paper may be more helpful for surgeons who choose whether to remove the kidney while the tumor's surgery heals a solid tumor.

Anonymous Patient Answer

Does wilms tumor run in families?

Data from a recent study identified a novel oncogene, PNRC, as the primary genetic basis of the familial occurrence of a subset of Wilms tumors.

Anonymous Patient Answer

How quickly does wilms tumor spread?

We have shown that the tumor grows fast, but there is no evidence for enhanced metastatic spread. However, the present data suggests that there is a metastatic organ in which the tumor cell spreads, which suggests that there is some heterogeneity in the growth rate of Wilms tumor.

Anonymous Patient Answer

What is the average age someone gets wilms tumor?

Wilms tumor is more likely to metastasize at a younger age than cancer of the bladder or testis. This information may be important in treatment planning and will aid in educating the public.

Anonymous Patient Answer
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