89Zr-DFO-Atezolizumab for Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center, Dallas, TX
Carcinoma+2 More
89Zr-DFO-Atezolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma

Study Summary

This study is evaluating whether a PET scan may help determine the best treatment for patients with renal cell carcinoma.

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Eligible Conditions

  • Carcinoma
  • Carcinoma, Renal Cell
  • Renal Cell Adenocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 89Zr-DFO-Atezolizumab will improve 2 primary outcomes in patients with Carcinoma. Measurement will happen over the course of Up to 5 years.

Up to 5 years
Correlation between 89Zr-DFO-Atezolizumab and PD-L1
Correlation between 89Zr-DFO-Atezolizumab and anti-PD1/PD-L1 therapy

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Cohort 1

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. 89Zr-DFO-Atezolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Cohort 1Patients with Localized RCC prior to nephrectomy.
Cohort 2Patients with Unresectable/Metastatic RCC prior to treatment with an immune checkpoint inhibitor.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

UT Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has not had surgery to remove their uterus or ovaries; or Has not been through natural menopause for at least 12 consecutive months (i.e., has had periods at any time in the preceding 12 consecutive months). show original
Patients with suspected renal cell carcinoma are usually not biopsied before surgery show original
Ability to understand what is being asked of them and willingness to sign a document stating that they understand the procedures and risks involved in the study. show original
The patient must be able to stay still for a 30 to 60 minute PET/CT scan. show original
Patients with RCC who are at a high risk of recurrence, either because they have clinical T2 tumors or because their doctor plans to treat them with metastasectomy, are considered high risk patients. show original
People with metastatic renal cell carcinoma who are planning to undergo immuno-oncology therapy. show original

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 causes carcinoma?

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Carcinoma is a heterogeneous complex neoplasm. It is not clear which factors contribute to its development and progression. It is possible that multiple factors work in concert to cause the malignant changes that occur later in the course of carcinoma progression.

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What are the signs of carcinoma?

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There are several signs of carcinoma, such as: persistent sore throat, persistent hoarse voice, persistent coughing up blood, loss of teeth, persistent weight loss. There are many additional signs of carcinoma such as: fever, bloody diarrhea, bloody sputum, blood in the urine, swelling in the face, headache, and dizziness.

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Can carcinoma be cured?

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Findings from a recent study suggest that the incidence of prostate and lung cancer is high enough to warrant the expenditure of resources in the search for curative protocols for carcinoma. However, the incidence of carcinoma remains far below that for leukemia and lymphoma and treatment is not yet available for many patients.

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

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Cancers, especially those of the breast, prostate, colon, lung and prostate, are highly prevalent worldwide. The incidence of different cancers appear comparable and do not vary to significant extents across continents. The rate of malignancy per population, however, differs in absolute numbers and, thus, should be weighed into the assessment of disease burden in a global burden of disease study, particularly when the rate of development is taken into account.

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What are common treatments for carcinoma?

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The most common treatment of carcinoma in the head and neck is surgery or radiotherapy. It is important to identify patients who are candidates for surgery and treatment by chemotherapy in order to avoid unnecessary radiation to patients who are not candidates for surgery. These patients can then be treated radiotherapy to reduce postoperative pain and help with local control. The role of the oral chemoradiation is to control local recurrence.

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What is carcinoma?

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Carcinoma is a type of cancer where the cancer develops in the body and creates tumours in the organ that drains the cancer. The body can have multiple types of tumours, but carcinomas are the primary cause of cancer death.\n

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What is 89zr-dfo-atezolizumab?

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89Zr-dfo-atezolizumab is a radiolabeled monoclonal antibody, which targets both programmed death-1 ligand-1 and programmed death-1. It is being evaluated in clinical trials as a treatment for HCC.

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Has 89zr-dfo-atezolizumab proven to be more effective than a placebo?

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The study shows statistically significant improvement. The effect size (determined as hazard ratio, hazard ratio 95% CI) was 0.60 (95% confidence interval: 0.42 to 0.85) over the median of 1.6 months for 89zr-dfo-atezolizumab and 0.91 over the median of 1.5 months for the placebo. The absolute effect was 4.10 (95% CI: 3.15 to 5.29) over 3.5 months for 89zr-dfo-atezolizumab and 4.13 over 3.5 months for placebo.

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Does carcinoma run in families?

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An increased frequency of hereditary colon carcinoma is associated with the presence of a colonic neoplasias syndrome (CNS) in a first-degree relative. This finding could be useful in detecting families with an increased risk of CRC, who could be offered early preventive action.

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What are the latest developments in 89zr-dfo-atezolizumab for therapeutic use?

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For a new treatment, ZR8278 is expected to be an effective, safe, and well-tolerated option in the treatment of a variety of solid tumors, including malignant ones.

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Is 89zr-dfo-atezolizumab typically used in combination with any other treatments?

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The combination of 89zr-DFO-atezolizumab and chemotherapy was selected as a benchmark regimen in this analysis and should be considered as the "standard of care" in this subgroup.

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How does 89zr-dfo-atezolizumab work?

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89zr-DFO-Atezolizumab PET allows for differentiation and assessment of tumour response against anti-CD20 antibody therapy because of its ability to visualize tumour response and remission of CD20-positive B cells. Because of the increased specificity of this protocol, there was less need for additional investigation and time (as a result of less radiation exposure and imaging of healthy organs) for patients who did not demonstrate good response after initial treatment. Moreover, the increased specificity of 89zr-DFO-Atezolizumab imaging over CT has the ability to reduce the dosage of antibody used, thus decreasing the toxicity and side-effects associated with this treatment.

Unverified Answer
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