Atezolizumab for Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
The University of Texas Southwestern Medical Center, Dallas, TX
Cancer+1 More
Atezolizumab - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a combination of chemotherapy drugs and a monoclonal antibody will help treat children with cancer.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Atezolizumab will improve 4 primary outcomes and 3 secondary outcomes in patients with Cancer. Measurement will happen over the course of 42 days post treatment..

42 days post treatment.
Number of participants with Acute Adverse Events (AEs)
48 months
Number of participants with Serious Adverse Events (SAEs)
Day 30
Number of participants with Dose-limiting Toxicities (DLTs)
Month 48
Duration of response
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
Atezolizumab with vincristine, irinotecan and temozolomide

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Atezolizumab 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.

Atezolizumab with vincristine, irinotecan and temozolomideAtezolizumab will be administered by intravenous (IV) infusion at a dose of 15 mg/kg (maximum 1200 mg) on Day 1 of each 21-day cycle, along with vincristine, irinotecan, and temozolomide at the above doses. Treatment will continue for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Vincristine
FDA approved
Temozolomide
FDA approved
Irinotecan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 24 up to end of study (approximately 48 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly month 24 up to end of study (approximately 48 months) for reporting.

Closest Location

The University of Texas Southwestern Medical Center - Dallas, TX

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Ability to comply with the study protocol, in the investigator's judgment
For efficacy cohort, disease must be measurable as defined by RECIST v1.1, mINRC, or RANO criteria (as appropriate). For the feasibility cohort, disease must be evaluable, but patients enrolled on the feasibility cohort will be prospectively assessed for measurable disease. If they are deemed to have measurable disease and PD-L1(+) staining, they will also be included in the efficacy cohort. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
For the efficacy cohort, PD-L1(+) tumor is required. Staining may be performed in the central site CAP/CLIA -certified laboratory using the 22c3 antibody for immunohistochemical analysis. PD-L1(+) status will be defined as staining on ≥1% of tumor cells or ≥1% of stroma. For the feasibility cohort, PD-L1 positivity is not required but will be performed centrally in all cases for exploratory biomarker studies.
Availability of a tumor specimen suitable for determination of PD-L1 status, either from initial diagnosis or from a recurrence. For PD-L1 staining to be performed at the central site, a formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections must be available along with an associated pathology report prior to study enrollment. Patients for whom the required number of slides are not available may still be eligible to enroll on study with PI approval
Signed informed consent
Relapsed or refractory solid tumor after at least one prior course of therapy. Hodgkin lymphoma or non-Hodgkin lymphoma are not permitted. Patients with CNS malignancy or asymptomatic CNS metastases may be enrolled, provided all of the following criteria are met. No metastatic or primary disease affecting the brainstem, midbrain, pons, or cerebellum, or within 10 mm of optic nerve. No history of leptomeningeal disease No history of intracranial or spinal cord hemorrhage. No evidence of progression of neurologic deficit, in the investigator's judgment, within 7 days prior to initiation of study medications.
Age ≥ 6 months and ≤ 30 years
Lansky Performance Status (patients < 16 years old) or Karnofsky Performance Status (patients ≥ 16 years old) ≥ 50
Adequate organ and marrow function as defined by the following laboratory values obtained within 21 days prior to initiation of study medication.
For patients without known bone marrow involvement: (1) Absolute neutrophil count ≥ 1.0 x 10^9 / L (1000/µL) without granulocyte colony-stimulating factor support (≥14 days after the last dose of a long-acting growth factor such as pegfilgrastim, or 7 days after short-acting growth factor), (2) Absolute lymphocyte count ≥ 0.5 x 10^9 / L (500/µL), (3) Platelet count ≥ 75 x 10^9 / L (75,000/µL) without transfusion in the last 7 days.

Patient Q&A Section

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

Does cancer run in families?

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Our observations suggest that cancer is under genetic control. In a subset of cancers, there is a strong clustering of cases over successive generations suggesting hereditary susceptibility.

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How many people get cancer a year in the United States?

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Overall rates of cancer vary by age, sex, marital status, and race/ethnicity for both sexes. These rates vary widely per state in the United States. Although the percentage of adults with any cancer in the state at any given time is similar, the average age of cancer diagnoses vary considerably from state to state in the United States. In addition to age and sex trends, socioeconomic factors, such as marital status and race, also contribute to changes in rates of cancer in the United States.

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What are common treatments for cancer?

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Cancer treatment is often complicated. It is usually composed of chemotherapy and radiation therapy, surgery, and chemotherapy. Some aspects of cancer treatment are also based on alternative medicine, such as herbal medicine.\n

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What causes cancer?

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The cause of cancer is not fully understood. Cancer is thought to involve both genetic, hormonal, and environmental factors working together to produce a deadly disease.\n\n- "

"Mastoidectomy\n\nA mastoidectomy is an operation in which the mastoid air cavity (the recess where the ear's middle ear sits) and a small part of the ear are removed. This procedure can alter the appearance of the mastoid region or the external ear, or reduce the size or volume of the mastoid cavity, and its ability to collect fluid (serom) (which increases the sensation of pain when touched) and air in certain cases.

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Can cancer be cured?

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Overall, the majority of cancer patients respond with partial to complete remissions with the best likelihood occurring in stage 1 disease and the fewest in stage 4. However, many of these diseases (especially metastatic disease) will remain lethal and cure is only accomplished in a very few patients. The most commonly accepted definition of cure of cancer does not apply to all patients.

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What are the signs of cancer?

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Most commonly cancers present as a lump that seems bigger than normal. On mammogram, cancer often produces mammographically palpable masses that are easier to feel with a needle or a finger than a normal breast. Most cancers are diagnosed by taking a biopsy, usually when the lump appears unlikely to be cancer. It can also be diagnosed by looking at the results of the full blood count, or by blood tests. All cancers are sometimes initially identified using a bone scan. If cancer is found and it occurs in close association with an area of bone deformity, one or more new signs of cancer can sometimes be found in relation to the cancer, the deformity and its surgery.

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What is cancer?

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Cancer is the result of uncontrolled cell division which leads to the formation of tumours. In most human cancers the process by which the cells turn normal tissue to cancer is still poorly understood and there may be an interplay between the tumor and its surrounding microenvironment. The aim of this review was to examine the interrelationships between cancer, inflammation, and infection in context of the pathogenesis of epithelial cancers.\n

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Who should consider clinical trials for cancer?

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A common rule of thumb for physicians considering testing of drugs is that if a new medication for cancer could help one or two patients for three months or more, it is worth investigating further. This does not mean that a drug should be tested for the benefit of every patient, however, because it takes thousands of patients to find significant changes that may not be detected by the researcher. A number of patient groups should be considered for clinical trials. Those with more than five years of life, who are more than five years from death, those who have metastatic disease, and those who are at high suspicion of having progression are the most likely to benefit from a trial.

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What are the latest developments in atezolizumab for therapeutic use?

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Atezolizumab's therapeutic application in patients with metastatic [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is expanding in accordance with the development of targeted therapy for cancer. Atezolizumab also shows the potential to be the first-line therapy for patients with advanced colon cancer.

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Is atezolizumab safe for people?

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These observations suggest that long-term safety may be ensured if low doses are given after initial dose determination by careful monitoring in patients with chronic inflammatory diseases like RA.

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Is atezolizumab typically used in combination with any other treatments?

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In this large cohort of patients, the addition of a targeted therapy to either standard of care or prior systemic therapy did not improve PFS or OS. In order to evaluate if this observation reflects patient selection bias or a limitation of our data, we will conduct a randomized trial to determine if patients on a given treatment regimen have a reduced risk of tumor progression.

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What are the common side effects of atezolizumab?

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Atezolizumab was well tolerated with overall similar safety and tolerability profiles compared to placebo. Atezolizumab-related adverse events were transient; serious adverse events were rare. Some of the common adverse events typically associated with anti-CTLA-4 therapy were reported more frequently with atezolizumab than with placebo. No clinically important differences noted in tolerability between atezolizumab and placebo occurred with any of the major infusion-related adverse events.

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