AVB-S6-500 for Transitional Cell, Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stephenson Cancer Center, Oklahoma City, OK
Transitional Cell, Carcinoma+2 More
AVB-S6-500 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may help treat advanced urothelial carcinoma.

See full description

Eligible Conditions

  • Transitional Cell, Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Transitional Cell, Carcinoma

Study Objectives

This trial is evaluating whether AVB-S6-500 will improve 3 primary outcomes and 5 secondary outcomes in patients with Transitional Cell, Carcinoma. Measurement will happen over the course of 28 days.

28 days
Incidence of Dose Limiting Toxicities
up to 2 years
Investigator assessed Objective Response Rate
Objective Response Rate
Safety and Tolerability
up to two years
Clinical Benefit Rate
Duration of Response
Overall Survival
Progression Free Survival

Trial Safety

Safety Progress

1 of 3

Other trials for Transitional Cell, Carcinoma

Trial Design

1 Treatment Group

Avelumab + AVB-S6-500
1 of 1
Experimental Treatment

This trial requires 19 total participants across 1 different treatment group

This trial involves a single treatment. AVB-S6-500 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.

Avelumab + AVB-S6-500
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
AVB-S6-500
2018
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Stephenson Cancer Center - Oklahoma City, OK

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The patient must have: 1) Progressed after treatment with at least 1 prior platinum-containing regimen, (e.g., received at least 2 cycles of cisplatin or carboplatin-based regimen) for inoperable locally advanced unresectable or metastatic urothelial carcinoma, 2) Experienced disease progression or recurrence within 12 months of completion of neoadjuvant or adjuvant cisplatin-based chemotherapy, OR 3) Ineligible for cisplatin-based chemotherapy due to eastern co-operative oncology group (ECOG) performance status 2, grade ≥2 neuropathy, GFR<60 mL/min, grade ≥2 hearing loss or New York Heart Association class III or worse congestive heart failure. show original
Age ≥18 years
A person with histologically confirmed locally advanced unresectable (T4b or N2/N3 disease) or metastatic urothelial cancer (including renal pelvis, ureters, urinary bladder, urethra) is considered Stage IV. show original
The patient has an ECOG performance status of ≤2, indicating they are in relatively good health. show original
The lesion must be measurable by RECIST version 1.1 The lesion must be measurable using the RECIST 1.1 guidelines. show original
Patients who are able to understand the risks and benefits of the procedure, and who are able to sign the informed consent form. show original
The ability to comply with protocol is an important skill for any employee show original
The patient has adequate blood and organ function according to the set guidelines. show original
We can perform the assay on a pretreatment baseline tumor specimen if one is available, or on a fresh tumor specimen if one is not available. show original
For women not of childbearing potential: Negative serum or urine pregnancy test within last six months. show original

Patient Q&A Section

What are the signs of carcinoma, transitional cell?

"The most frequent signs and symptoms of carcinoma, transitional cell include, urgency of urination, difficulty urinating, urinary frequency/nocturia and in older men haematuria. All these symptoms may lead to further testing for prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, transitional cell?

"A variety of cell types can develop from the epithelium of the urinary bladder, and these cells can develop into cancer. Squamous cell carcinoma and transitional cell carcinoma differ in their clinical behavior and prognosis." - Anonymous Online Contributor

Unverified Answer

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

"CCA, TCA, and T2 are on the rise. The number of new cases will increase by more than 100% for CCA and almost triples for TCA by 2020." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, transitional cell?

"The etiology of carcinoma, transitional cell (CT) is highly controversial. However, because of the frequency of CTs in patients with BPH on active surveillance, and since the incidence of CT in patients with BPH on treatment has not been definitively established, we will limit our discussion to those cases in which prostatic carcinoma was present on initial biopsy and/or the specimen itself. A number of putative infectious causes are discussed, with special attention to those known to be pathogenic in BPH. Since evidence regarding the role of coxsackie B virus (which most likely causes BPH but whose role in causing carcinoma, CT is less clear) is scarce, any role it may play, however, remains unclear." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, transitional cell be cured?

"There is no cure for carcinoma, transitional cell. However, with proper treatment, patients will always feel a degree of improvement in symptoms with prolonged survival." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, transitional cell?

"Nearly 60% of [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) are transitional cell carcinomas. Common treatments include chemotherapy, surgery, and chemotherapy with cisplatin. Transurethral resection (TUR) often proves to be the most successful treatment of TCC, although a combination approach may be needed. Although these patients often respond well to chemotherapy, the use of adjuvant chemotherapy at the time of surgery cannot be recommended. Patients whose cancer remains in one area may benefit from the use of concomitant chemotherapy prior to cystectomy." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of avb-s6-500?

"In evaluating the most common side effects that occur in the clinical phase 1 trials evaluating avb-s6-500, the most frequently observed adverse events (AEs) were related to diarrhea (>10%) and headache (>20%). For the majority of these events (67.3%), the median of the highest reported level of the AE in the clinical trials was ≥20%. Eighty-seven percent of the patients experienced diarrhea of grades ≥3, and 50% of patients experienced headache of grades >3. The most frequent grade of diarrhea (51.9%) was categorized as moderate and included nausea and dehydration. The most frequently observed grade of headache (46.7%) was category 4 (severe headache)." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, transitional cell run in families?

"Although the frequency and the occurrence of endometrial carcinoma among first-degree relatives of women with a transitional cell adenocarcinoma is quite high (13.8%), they are almost certainly under diagnosed because the disease tends to be asymptomatic. A large study is needed to determine the prevalence and occurrence of such a disease." - Anonymous Online Contributor

Unverified Answer

Is avb-s6-500 typically used in combination with any other treatments?

"Avb-s6-500 is not most commonly used in combination with any other treatments. Further research that looks at the most effective treatment for stage III transitional cell carcinoma of the urinary bladder is needed." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, transitional cell?

"In conclusion, transitional cell carcinomas are more likely to be caused by environmental carcinogens rather than an imbalance in the natural history of neoplastic growth. In other words, cancer is caused by environmental carcinogens. It is likely the primary cause of urinary tract carcinomas, because other mechanisms for urinary tract cancer should be investigated." - Anonymous Online Contributor

Unverified Answer

Does avb-s6-500 improve quality of life for those with carcinoma, transitional cell?

"Findings from a recent study from this study show that AVABs can reduce many of the symptoms ascribed by patients to urinary incontinence, constipation or pain through puerilization of the bladder wall, sphincter or pelvic floor dysfunction. The most common AVABs used, AVAB-S6 and AVAB-S6-100, were well tolerated by patients." - Anonymous Online Contributor

Unverified Answer

What does avb-s6-500 usually treat?

"The treatment of renal cell cancer with avb-s6-500 was well well tolerated, with progressive tumor shrinkage occurring in up to 75% of patients, although most patients remained clinically stable for up to 3 years after the commencement of treatment. However, in this subgroup of patients with renal cell cancer, distant metastases did progress. The most common sites of distant metastases were in the liver and brain. However one retrospective cohort study of metastatic renal cell cancer showed that metastatic tumor growth did not vary with the time between commencement of avb-s6-500 treatment and progression but that the survival after progression was significantly better after avb-s6-500." - 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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