CLINICAL TRIAL

Atezolizumab for Carcinoma

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Waitlist Available · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a combination of a vaccine and a drug can treat cancer.

See full description

About the trial for Carcinoma

Eligible Conditions
Carcinoma · Transitional Cell, Carcinoma · Carcinoma, Transitional Cell

Treatment Groups

This trial involves 2 different treatments. 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 & 2 and have already been tested with other people.

Experimental Group 1
CELLECTRA™ 2000
DEVICE
+
Atezolizumab
DRUG
+
INO-5401
BIOLOGICAL
+
INO-9012
BIOLOGICAL
Experimental Group 2
CELLECTRA™ 2000
DEVICE
+
Atezolizumab
DRUG
+
INO-5401
BIOLOGICAL
+
INO-9012
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CELLECTRA™ 2000
2017
Completed Phase 2
~40
Atezolizumab
FDA approved
Rocakinogene sifuplasmid
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 2 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:
Sign an Informed Consent Form (ICF);
Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra);
For Cohort A: Subjects who have radiographically confirmed disease progression during or following treatment with an anti-PD-1/PD-L1 based therapy;
For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UCa and ineligible ("unfit") for cisplatin-based chemotherapy;
Have measurable disease, as defined by RECIST version 1.1;
Have a performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Performance Scale;
Have life expectancy of >/= 3 months;
Be willing to provide a tissue sample for pre-treatment intra-tumoral assessment of proinflammatory and immunosuppressive factors;
Have electrocardiogram (ECG) with no clinically significant findings as assessed by the investigator performed within 28 days prior to first dose;
Demonstrate adequate hematological, renal, hepatic, and coagulation function;
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At baseline, Weeks 3, 6, 9, 12 and every 12 weeks thereafter up to end of study (up to approximately 2 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: At baseline, Weeks 3, 6, 9, 12 and every 12 weeks thereafter up to end of study (up to approximately 2 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At baseline, Weeks 3, 6, 9, 12 and every 12 weeks thereafter up to end of study (up to approximately 2 years).
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 3 primary outcomes and 5 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of From baseline up to 90 days after last dose of study medication (up to approximately 2 years and 3 months).

Number of Adverse Events
FROM BASELINE UP TO 90 DAYS AFTER LAST DOSE OF STUDY MEDICATION (UP TO APPROXIMATELY 2 YEARS AND 3 MONTHS)
FROM BASELINE UP TO 90 DAYS AFTER LAST DOSE OF STUDY MEDICATION (UP TO APPROXIMATELY 2 YEARS AND 3 MONTHS)
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator Review in Cohort A
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
Duration of Response (DoR)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
ORR by Immune RECIST (iRECIST)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
ORR by RECIST version 1.1 by Investigator Review in Cohort B
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
Progression Free Survival (PFS) as Assessed by RECIST version 1.1 and iRECIST
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
FROM BASELINE TO DISEASE PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST (UP TO APPROXIMATELY 2 YEARS)
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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.

Can carcinoma be cured?

Carcinoma cannot be cured. Some localized carcinoma may be cured if found and resected soon after it is diagnosed correctly, but most forms of the disease do not respond to treatment.

Anonymous Patient Answer

What is carcinoma?

The main objective of this article was to update the treatment of patients with cancer with respect to the diagnosis method used. Considering the differences found, it is probable that in the near future, a more effective and practical method will be utilized. In the near future, the more precise and accurate information on the patient's condition will be obtained from a variety of diagnostic tools as a basic need before administering treatment. In addition, the data regarding treatment will be based on the patients' own statements and will be obtained from patients who need to be under treatment. In conclusion, it is crucial to establish a standardized and rational method of treatment for cancer and to ensure that a standard system for diagnosing the disease among patients is in place.

Anonymous Patient Answer

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

At a population level, the number of people diagnosed with primary cancer from 1979 thru 1995 in the US was approximately 1,600 per year. That is, approximately 1 in 2 patients with primary cancer in the US is diagnosed each year. If these patients develop additional cancers, the number may be higher. It is difficult to establish an unbiased estimate of the number of patients with cancer of any type that develops primary cancer in the US each year. Estimates of the number of newly diagnosed cancers and the burden of cancer can be derived from different sources.

Anonymous Patient Answer

What causes carcinoma?

Carcinomas show a diverse range of causation, with environmental factors influencing most cases and inherited predisposing genetic mutations affecting a small percentage of cases. The vast majority of cancer is caused by environmental toxicants. These are also the only factors to show an increased risk in a prospective cohort study. This is particularly true of breast and endometrial cancer. However, the link between environmental toxicity and causation is an emerging, controversial and evolving area.

Anonymous Patient Answer

What are the signs of carcinoma?

There are many signs related to carcinoma of the prostate. These can be divided into those seen in the clinical examination and those seen on MRI of the prostate, including PSA. Paediatric carcinoma has a particular pattern. The main symptoms include hematuria, dysuria, and a palpable lump in the prostate.\n

Anonymous Patient Answer

What are common treatments for carcinoma?

Most patients diagnosed with carcinoma receive chemotherapy in the adjuvant setting. Most patients diagnosed with carcinoma develop recurrent disease within the first year post resection. The majority of patients do not experience an adequate treatment response. Treatment is palliative in nature and most patients experience a brief, yet intense, dying experience.

Anonymous Patient Answer

What is the latest research for carcinoma?

There's a wide range of research topics, but one important idea that we all must remember is to never give up as a fight to treat and cure carcinoma. By remembering this common theme, this cancer will never go away.

Anonymous Patient Answer

What is the survival rate for carcinoma?

There is a high survival rate for carcinoma after surgery. The rate of recurrence, however, remains stable within the same time period despite many recurrences of carcinoma. In contrast, survival rate drops gradually after the time period of 5 years, which suggests that the quality of management improves as the patient ages.

Anonymous Patient Answer

What are the chances of developing carcinoma?

People taking aspirin have about 75% of the normal population risk of [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer); a further 17% of people who take non-steroidal anti-inflammatory drugs have colon cancer. The majority of the people admitted to surgeons have some degree of inflammation and that seems to increase the chance of development of cancer. Cancer risks seem to increase with smoking, and people with the BRCA mutation. However, in the current study of this general population, the risks were much lower than those described from cancer data for people known to have the disease. It raises important questions about how general populations are being told about cancer risks in general, and about potential benefits and risk versus benefit in specific cases.

Anonymous Patient Answer

What is the average age someone gets carcinoma?

In the United States, the age of diagnosis for carcinoma is not decreasing. Results from a recent paper highlights the need for continuing efforts [to identify and treat the disease as early as possible in order to decrease the high mortality rate of people suffering from carcinoma disease (http://www.ohsu.edu/news/Pages/News_pages/Care_and_Cancer/Cancer_Basics.aspx)] as well as continued surveillance of new cases at increased frequency.

Anonymous Patient Answer

How serious can carcinoma be?

There is a considerable overlap in the symptoms of carcinoma and other serious medical conditions. Consequently, many people with cancer are initially misdiagnosed or fail to receive a correct diagnosis.

Anonymous Patient Answer

Does carcinoma run in families?

In a recent study, findings confirms a high prevalence of cancer in multiple families, and highlights the importance of performing tumour family history. We found no correlation between multiple family members' cases and the patients' familial history, suggesting that genetic predisposition has no role in this cancer in the majority of cases in this cohort.

Anonymous Patient Answer
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