CLINICAL TRIAL

Atezolizumab for Cancer

Grade I
Metastatic
Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a type of immunotherapy may help treat cancer.

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About the trial for Cancer

Eligible Conditions
Neoplasms · Unresectable Malignant Solid Neoplasm · Hematopoietic and Lymphoid Cell Neoplasm · Metastatic Malignant Solid Neoplasm

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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Atezolizumab
DRUG
Laboratory Biomarker Analysis
OTHER
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
Atezolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. 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:
Solid tumor patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 15 mm (>= 1.5 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Leukemia and non-Hodgkin's lymphoma patients must have measurable disease according to the revised response criteria for malignant lymphoma
Histologically or pathologically confirmed malignancy (hematologic or solid tumor) that is metastatic or unresectable and for which standard of care therapy does not exist or is no longer effective
ACT infusion prior to study enrollment (cohorts include ACT with tumor infiltrating lymphocytes [TIL], human leukocyte antigen [HLA]-class I T cell receptor [TCR]-engineered lymphocytes, HLA-class II TCR-engineered lymphocytes, and chimeric antigen receptor [CAR]-engineered T cells)
Prior ACT therapy should be completed, and residual disease documented by either radiographic progression or active disease observed on biopsy (i.e. hematologic or solid tumor malignancy must be deemed active by the treating investigator); the investigator may deem that the disease is active on the basis of a pre-treatment biopsy demonstrating viable tumor cells or clinical progression of disease (i.e. RECIST progression is not required)
Disease suitable for assessment by pre- and post-biopsies
There is no limit to the number of lines of prior therapy; prior anti-programmed cell death (PD)-1 or anti-PD-ligand (L)1 therapy and other immunotherapies are allowed
Prior anti-PD-1 or anti-PD-L1 therapy may not be administered after ACT and before study atezolizumab (MPDL3280A) administration
All ACT related toxicities resolved to grade 1 with the exception of alopecia, vitiligo and endocrine abnormalities requiring replacement therapy which may be grade 2
No prior other anti-cancer therapy, including ACT, for 28 days prior to study administration of atezolizumab
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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: Up to 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
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 Atezolizumab will improve 1 primary outcome and 7 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 6 weeks.

Incidence of adverse events
UP TO 6 WEEKS
Will be assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 (CTCAE version 5.0 will be used starting 04/01/2018). Adverse experiences will be graded and recorded throughout the study and during the follow-up period.
UP TO 6 WEEKS
Biomarker analysis
UP TO 1 YEAR
Will be tailored for each cohort as continuous variables, depending on the type of adoptive cell transfer (ACT) previously administered.
UP TO 1 YEAR
Anti-tumor activity
UP TO 1 YEAR
Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients.
UP TO 1 YEAR
The response rate
UP TO 1 YEAR
Will be assessed using immune related Response Criteria (irRC) and Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, or other tumor-specific criteria. Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients.
UP TO 1 YEAR
Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment
UP TO 1 YEAR
Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients.
UP TO 1 YEAR
Phenotype and function of engrafted T cells following atezolizumab administration
UP TO 1 YEAR
Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients.
UP TO 1 YEAR
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Patient Q & A Section

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

What are the signs of cancer?

There are a few alarming signs, and it may be early signs of cancer. I have always been suspicious about cancer. My grandmother had it – my mother died of cervical cancer. So anytime any one of you have any unexplained symptoms, and I mean unexplained symptoms, take them seriously, even if they are benign. Get screened as your age and gender warrant it. I must have been about 20 by the time I got screened. I know that is so old.\n

Anonymous Patient Answer

What is cancer?

Cancer is a disease that can cause a range of symptoms that differ from symptom to symptom. Symptoms can be the signs of other chronic conditions such as cardiovascular disease, and cancer can go undiagnosed for many years.

Anonymous Patient Answer

Can cancer be cured?

According to the cancer patient I interviewed, yes cancer can be cured but, unfortunately, there is a huge price of cure. As soon as the disease has spread all over the body, it can't be cured, the only way to cure it is to have a very big surgery to remove it, and then just live like a normal person with the help of a high protein diet, and go through regular checkups regularly in order to see that there aren’t any signs of cancer, other than the tumour at the site of surgery. In order to survive from a cancer treatment, you must be able to live a normal life once it had been cured of the cancer.

Anonymous Patient Answer

What are common treatments for cancer?

No single treatment will work in every case, and patients will need many different treatments for their cancer during their treatment. The best treatment depends on the type of cancer and where it is located. Most patients will need to be treated for both their cancer and their side effects.

Anonymous Patient Answer

What causes cancer?

Our model shows that the causes of cancer are multiple, and do not all begin with the genes, the environment, or our behavior, but can come from other factors such as aging (when the body is old, the body is broken), diet, alcohol and tobacco use, pollutants, and many other things.

Anonymous Patient Answer

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

1,000,000 New Cases of breast cancer will be diagnosed; 250,000 new cases of pancreatic cancer; 320,000 new cases of colorectal cancer; and 230,000 new cases of lung cancer.

Anonymous Patient Answer

Does cancer run in families?

Findings from a recent study do not support the notion that cancer does run in families in a manner compatible with what is observed in hereditary conditions.

Anonymous Patient Answer

What are the latest developments in atezolizumab for therapeutic use?

Combination therapy with a PD-L1 inhibitor has a strong synergy, which in part is mediated by the synergy with the PD-L1 signaling pathway. Therefore, the therapeutic effects of atezolizumab in combination with anti-PD-L1 therapies continue to show improvement in clinical outcomes in various solid tumors compared with single agent anti-PD-L1 therapy in many clinical trials.

Anonymous Patient Answer

What is the average age someone gets cancer?

  1. Breast cancer: age 39.3 and 40.7 years respectively 2. Colorectal cancer: age 72.8 years for both genders 3. Lung cancer: age 61 years for both genders 4. Cervical cancer: age 64 years for both genders 5. Melanoma: age 84.3 years for women only 6. Oesophageal cancer: age 68.3 years for both sexes 7. Ovarian cancer: age 49.7 years for both genders 8. Head and neck cancer: age 69 years for men, 49.5 years for women. Prostate cancer: age 70 years for both sexes 9. Pancreatic and periampullar cancer: 46.4 and 45.
Anonymous Patient Answer

What are the common side effects of atezolizumab?

Atezolizumab is associated with severe or moderate infusion-related reactions with or without concomitant immunosuppressive agents, as well as immune-related adverse events in up to 10% patients. Other severe side effects include interstitial lung disease, pneumonitis, pneumonitis exacerbation, anemia, thrombotic events, cardiovascular toxicity and neutropenia.

Anonymous Patient Answer

How does atezolizumab work?

The antitumor effects of atezolizumab do not involve a reduction in tumor mass, so is not an antiangiogenic agent. Rather, in vitro and in vivo, this agent may cause the cell death of tumor-infiltrating CD8+ T cells, thus interfering with the local environment, and leading to a reduction in tumor mass. The tumor-infiltrating CD8+ T cells can be replaced at time of disease progression. This is a highly interesting observation in this tumor with an immunosurvival and antitumor response, with the potential for long-term survival.

Anonymous Patient Answer

Is atezolizumab safe for people?

Atezolizumab and bevacizumab are two immunosuppressant drugs which are approved for metastatic colorectal cancer and NSCLC, respectively. Atezolizumab is a humanized monoclonal antibody against ICOS (CD278), the receptor for the immune checkpoint molecule ICOS/ICOSL. In February 2014, atezolizumab was first administered to patients undergoing neoadjuvant chemotherapy. The current studies show that atezolizumab is safe. This finding may be especially helpful for patients as it may make chemotherapy more tolerable and less dangerous. This new drug has great potential for improving the outcome of chemotherapy.

Anonymous Patient Answer
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