N-803 and BCG for Bladder Cancer, Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Michigan, Ann Arbor, MI
Bladder Cancer, Cancer+1 More
N-803 and BCG - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may help treat bladder cancer.

See full description

Eligible Conditions

  • Bladder Cancer, Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Bladder Cancer, Cancer

Study Objectives

This trial is evaluating whether N-803 and BCG will improve 1 primary outcome and 2 secondary outcomes in patients with Bladder Cancer, Cancer. Measurement will happen over the course of 12 Months.

12 Months
Disease-Free Rate
24 months
Response
60 months
Complete Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Bladder Cancer, Cancer

Trial Design

1 Treatment Group

BCG+N-803
1 of 1
Experimental Treatment

This trial requires 200 total participants across 1 different treatment group

This trial involves a single treatment. N-803 And BCG 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 & 3 and have had some early promising results.

BCG+N-803

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 60 months for reporting.

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Bladder Cancer, Cancer or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female patients 18 years of age or older
Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.
Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
BCG-unresponsive disease as defined as: (a) Persistent or recurrent CIS (+/- recurrent Ta/T1 disease) within 12 months of receiving adequate BCG (at least five of six doses doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (b) Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at least five of six doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (c) T1 high-grade disease at the first evaluation following an induction BCG course alone (at least five of six doses of an initial induction course).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Patient Q&A Section

How quickly does urinary bladder cancer spread?

"The bladder cancer is a locally confined disease, and in an excellent proportion of such patients a complete cytoreductive surgery along with a radical pelvic lymphadenectomy could be performed. In these patients the disease could have been treated by transuranic alpha-irradiation in a good proportion." - Anonymous Online Contributor

Unverified Answer

Can urinary bladder cancer be cured?

"When used in the correct dose, cannabis and its psychoactive compounds do not appear to pose a significant risk of bladder cancer and may play a role in the treatment of bladder cancer by reducing discomfort associated with intravesical immunotherapy." - Anonymous Online Contributor

Unverified Answer

What is urinary bladder cancer?

"Urinary bladder carcinogenesis is typically a multifactorial process. The majority of urothelial bladder cancers present in young patients. The role of tobacco smoking and non-specific aetiologies in the pathogenesis of bladder cancer are hotly debated. The majority of bladder cancers in the UK are superficial malignant urothelial tumours. Patients with high-grade non-muscle-invasive bladder cancer might respond well to intravesical therapy following transurethral resection. Patients with high-grade muscle invasive disease should be considered for more aggressive multimodal protocols." - Anonymous Online Contributor

Unverified Answer

What causes urinary bladder cancer?

"No common causes for bladder cancer have been reported. On the other hand, a study on Chinese patients from Taiwan has found evidence that diabetes mellitus can increase the risk of bladder cancer and that an infection with schistosomiasis can be associated with an increased risk for bladder cancer." - Anonymous Online Contributor

Unverified Answer

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

"There are 60,800 new diagnoses of urinary bladder cancer. On average, women are diagnosed later than men, and the prevalence of bladder cancer increases with age." - Anonymous Online Contributor

Unverified Answer

What are common treatments for urinary bladder cancer?

"Urinary bladder cancer is often treated with surgical resection. Surgery can be used to remove only the urinary bladder without resection of surrounding lymph nodes. Radiation is rarely used for localized disease but may be used in locally advanced cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of urinary bladder cancer?

"Symptoms of urinary bladder cancer include decreased bladder capacity, urinary frequency, pain in the belly, a desire to urinate at night or frequent leaks from the urinary bladder. Symptoms can also include hematuria, abnormal urine colour, swollen knees, or numbness in the feet." - Anonymous Online Contributor

Unverified Answer

Does n-803 and bcg improve quality of life for those with urinary bladder cancer?

"The administration of N-803 plus BCG did not significantly improve or interfere with quality of life in this group of patients evaluated in a randomized trial." - Anonymous Online Contributor

Unverified Answer

Has n-803 and bcg proven to be more effective than a placebo?

"In the context of the NCI-funded CANCER trial, the effect of BCG on cancer-related survival was statistically significant. Results on other outcomes were less convincing. Although the numbers were small, the result that we observed was similar to those we had reported in the earlier CANCER trial. Although there were no differences in PFS or OS between treatment groups, there was no difference in PFS between n-803 and BCG. The conclusion that there were no statistically significant differences in all outcomes is consistent with the existing evidence and suggests that the results may be due to chance. This finding was also consistent with previous CANCER trial results." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating urinary bladder cancer?

"The most important progress has been in detecting and treating bladder cancer in the early stages. Findings from a recent study of randomized controlled trials are awaited to establish the efficacy of various systemic agents, both neoadjuvant and adjuvant." - Anonymous Online Contributor

Unverified Answer

Is n-803 and bcg typically used in combination with any other treatments?

"N-803, BCG, and combined chemotherapies are typically used in conjunction with other cancer therapies, but their respective effectiveness remains poorly defined. A review of the literature is consistent with the use of N-803, combined chemotherapies (BCG, or with VEGF inhibitors among others), and chemotherapy using methotrexate alone in the setting of advanced UCB. There is little data supporting the use of N-803 and BCG in conjunction with one another. Further studies are warranted to assess the potential benefit of these agents to improve patient outcomes in UCB and to identify patients who are likely to derive greater benefit from treatment regimens that include N-803, BCG, chemotherapy, and radiation." - Anonymous Online Contributor

Unverified Answer

Does urinary bladder cancer run in families?

"Urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is a heterogeneous neoplasm. Both the presence and absence of cancers in first degree relatives may be useful to identify families of patients with increased risk, thereby providing a useful tool to identify the genetic causes of this disease. This article is protected by copyright. All rights reserved." - Anonymous Online Contributor

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