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Atezolizumab + Chemotherapy for Pediatric Solid Cancers
Study Summary
This trial is testing a combination of drugs to treat pediatric cancer patients who have relapsed or are unresponsive to other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227Trial Design
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- You have a history of severe or uncontrolled asthma.My neurological condition has been stable for the last week.I am on a stable or reducing dose of steroids for my CNS condition, approved by the study lead.I've had high-dose chemotherapy and stem-cell therapy within the last 3 months.My kidney function, measured by creatinine levels or clearance, is within the normal range.You have provided written permission to participate in the study.My cancer test used a specific method and was done in a certified lab.I have pain from my cancer that isn't relieved by treatment.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have an autoimmune thyroid condition but am on medication for it.Your blood counts are within normal range without the need for medication or transfusions in the last 7-14 days.I have not received a live vaccine within the last 30 days and do not plan to during or within 5 months after treatment.I have not used herbal cancer treatments in the last week.I have active tuberculosis.I haven't had stem cell or organ transplants, or certain immune therapies, and didn't worsen on irinotecan or temozolomide.I have a skin condition like eczema or psoriasis, but it's mild and well-controlled with weak creams.My cancer shows PD-L1 positive status.I am between 6 months and 18 years old.I can do most activities but may need help.My disease can be evaluated and I may be checked for measurable disease.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with levels ≤ 3 times the normal.My liver enzymes are within normal limits for my age.I do not have an autoimmune disease or immune deficiency.My cancer can be measured or seen on scans, and it has grown despite previous treatments.My tumor is PD-L1 positive.My recent tests show my organs and bone marrow are functioning well.I don't have any health issues that would make it unsafe for me to take a new drug.I am taking antibiotics to prevent infections.I frequently need procedures to remove excess fluid from my body.I have a history of specific lung conditions or signs of lung inflammation on a recent CT scan.I have trouble breathing even when resting or need extra oxygen.I do not have uncontrolled seizures and am on a stable dose of seizure medication that does not strongly affect CYP3A4.I have recovered from previous cancer treatment side effects, except for hair loss or stable conditions needing ongoing treatment.I have active hepatitis C.I haven't had major heart problems or strokes in the last 3 months.My cancer's PD-L1 status is not required but will be tested for research.I can provide a tumor sample and report for PD-L1 testing.My pain medication dose has been stable for at least 2 weeks.I haven't taken any immune-weakening drugs in the last 2 weeks.I've only had short-term immunosuppressants, approved by the study's lead researcher.I am using or will use highly effective birth control during and for 5 months after treatment.I have healed from any biopsy or device placement before starting the study medication.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I do not have any ongoing or untreated serious infections.I will use highly effective birth control and not donate sperm during and for 5 months after treatment.I have never had bleeding in my brain or spinal cord.I am taking steroids for asthma, COPD, low blood pressure, or adrenal issues.I haven't taken strong CYP3A4 or UGT1A1 inhibitors in the last 12 days.I haven't taken long-acting blood cell boosters in the last 2 weeks or short-acting ones in the last week.I haven't taken any long-lasting antibody treatments recently.My cancer has not spread to specific areas of my brain or close to my optic nerve.You are allergic or have a severe reaction to any of the study medications.I have never had cancer spread to the lining of my brain and spinal cord.I am a woman who can still have children.You have participated in another clinical trial or received experimental treatment within the past 21 days.I understand that periodic abstinence and withdrawal are not considered reliable contraception methods for this trial.I haven't had targeted cell therapy in the last 28 days.My recent tests show my organs and bone marrow are functioning well.I have brain cancer or brain metastases but meet specific health criteria.I haven't had brain surgery or brain radiation in the last 30 days.I have a solid tumor that didn't respond to treatment, but not lymphoma, and no severe brain issues.I have had lung scarring from previous radiation treatment.You are able to follow the study rules according to the investigator's opinion.My solid tumor cancer came back or didn't respond after my first treatment.My blood thinner medication dose has been stable.I agree to not have sex or use birth control and not donate sperm.I am between 6 months and 30 years old.I am currently on medication for hepatitis B.I haven't had major surgery in the last 30 days and don't expect any in the next 4 treatment cycles.I can provide a sample of my tumor for PD-L1 testing.My cancer is confirmed to be rhabdomyosarcoma.I have Type 1 diabetes that is managed with insulin.My cancer has grown in an area previously treated with radiation.I can provide a tumor sample for PD-L1 testing.I can receive blood transfusions to meet the trial requirements.To participate in this study, you must use a very effective form of birth control, such as surgery to prevent pregnancy, a hormone-based method that stops ovulation or an intrauterine device that releases hormones or copper.My tumor is PD-L1 positive.I haven't taken cancer drugs that don't affect bone marrow within the last week.I don't have stomach or bowel problems affecting drug absorption.I do not have Hodgkin or non-Hodgkin lymphoma.
- Group 1: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcoma
- Group 2: Feasibility Cohort: Patients with relapsed or refractory solid tumors
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research open to senior citizens?
"This medical trial is recruiting participants who are between 6 and 30 years of age."
What is the current enrollment size of this clinical trial?
"This research is no longer accepting participants. Originally posted on January 1st 2023, the trial's last update was August 30th 2022. If you are looking for alternative studies, there are currently 2585 cancer-related trials recruiting and 997 utilizing Atezolizumab as a treatment option actively seeking people to participate."
Has there been past research on Atezolizumab's efficacy?
"Presently, there are 997 Atezolizumab clinical trials in progress with 227 of those being Phase 3. Most studies for this medication are conducted at Woolloongabba, Queensland yet 44346 other sites worldwide have launched similar research projects."
What medical conditions does Atezolizumab typically address?
"Atezolizumab is a viable treatment option for gestational trophoblastic disease, neoplasms and chronic lymphocytic leukaemia (CLL)."
Has the FDA greenlighted Atezolizumab for therapeutic use?
"The safety profile of Atezolizumab is estimated to be a 2, as this trial is currently in its second phase and there are indications that it may be safe, yet no evidence has been presented regarding efficacy."
Could I be eligible to participate in this trial?
"Successful applicants for this medical trial must have cancer, be aged 6 to 30 years old and join a cohort of no more than 30 individuals."
Are there any opportunities remaining for people to join this clinical investigation?
"Clinicaltrials.gov confirms that, as of August 30th 2022, this medical research project is no longer recruiting participants. Although the trial in question has ceased recruitment activities, there are 3,582 other studies currently enrolling individuals to participate."
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