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Monoclonal Antibodies

Vicineum for Bladder Cancer

Phase 1

Waitlist Available

Led By Vladimir A Valera Romero, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from start of therapy to disease recurrence or last follow up; up to 1 year.

Awards & highlights

Study Summary

This trial is testing if the drugs Durvalumab and Vicineum together are safe and effective to treat people with bladder cancer that has not spread to the muscle in the bladder.

Eligible Conditions

Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from start of therapy to disease recurrence or last follow up; up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from start of therapy to disease recurrence or last follow up; up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from start of therapy to disease recurrence or last follow up; up to 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Grades 1-5 Adverse Events

Secondary outcome measures

Change in Programmed Cell Death Protein 1 (PD-1) Levels Between Responders and Non-Responders

Change in Programmed Cell Death Protein 1(PD-1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD)

Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD)

+7 more

Other outcome measures

Dose-Limiting Toxicity (DLT)

Maximum Tolerated Dose (MTD) of Durvalumab

Maximum Tolerated Dose (MTD) of Vicineum

+1 more

Side effects data

From 2022 Phase 1 trial • 15 Patients • NCT03258593

67%

Hematuria

42%

Urinary frequency

42%

Pruritus

42%

Urinary tract infection

33%

Diarrhea

25%

Rash maculo-papular

25%

Proteinuria

17%

Allergic rhinitis

17%

Constipation

17%

Creatinine increased

17%

Fatigue

17%

Hypertension

17%

Hyperthyroidism

17%

Watering eyes

17%

Dry skin

17%

Hypotension

17%

Memory impairment

17%

Lipase increased

17%

Chills

17%

Atrial fibrillation

17%

Dysuria

17%

Insomnia

17%

Urinary urgency

17%

Dry mouth

17%

Bladder infection

17%

Headache

17%

Serum amylase increased

17%

Bladder spasm

Chest pain - cardiac

Myalgia

Renal and urinary disorders - Other, Bilirubinuria

Dyspepsia

Renal and urinary disorders - Other, specify

Thromboembolic event

Urinary retention

Dehydration

Erythema multiforme

Fever

Renal and urinary disorders - Other, Nitrite positive urine

Renal and urinary disorders - Other, decreased force of stream

Reproductive system and breast disorders - Other, Penile itching

Scrotal pain

Flank pain

Hyperkalemia

Muscle cramp

Renal and urinary disorders - Other, UTI

Sinusitis

Pain in extremity

Renal and urinary disorders - Other, Cloudy urine

Sinus tachycardia

Anxiety

Edema limbs

Hyponatremia

Malaise

Eye disorders - Other, Hordeolum

Musculoskeletal and connective tissue disorder - Other, Left side pubic pressure

Productive cough

Nasal congestion

Oral pain

Non-cardiac chest pain

Atrial flutter

Abdominal pain

Skin infection

Tinnitus

Cardiac disorders - Other, Irregular heart rate

Toothache

Hypoglycemia

Hypokalemia

Fall

Hot flashes

Hemoglobinuria

Urinary incontinence

Bruising

Hypophosphatemia

Joint range of motion decreased

Skin and subcutaneous tissue disorders - Other, diffuse patchy rash

Sinus bradycardia

Skin and subcutaneous tissue disorders - Other, diffuse patchy skin

Nausea

Bloating

Eye disorders - Other, Ring of black string

Vaccination complication

100%

80%

60%

40%

20%

Study treatment Arm

Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg

Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg

Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg

Trial Design

4Treatment groups

Experimental Treatment

Group I: Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mgExperimental Treatment11 Interventions

Durvalumab + Vicineum, escalating doses. Up to 2 dose levels will be evaluated in the first 6 - 12 participants.

Group II: Level 1, Durvalumab 1500mg intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mgExperimental Treatment11 Interventions

Level 1, Durvalumab 1500mg intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mg

Group III: Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mgExperimental Treatment11 Interventions

Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Up to 24 participants.

Group IV: Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD)Experimental Treatment11 Interventions

Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cystoscopy

2016

Completed Phase 4

~810

Bladder Biopsy

2018

Completed Phase 1

~20

Electrocardiogram

2014

Completed Phase 2

~3060

TURBT

2017

Completed Phase 3

~1700

Urine cytology

2019

Completed Phase 1

~270

Acetaminophen

2017

Completed Phase 4

~2030

Antihistamine

2016

Completed Phase 3

~220

MRI

2009

Completed Phase 2

~1370

2017

Completed Phase 3

~3200

Durvalumab

2017

Completed Phase 2

~3870

Vicineum

2018

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,257 Total Patients Enrolled

Vladimir A Valera Romero, M.D.Principal InvestigatorNational Cancer Institute (NCI)

2 Previous Clinical Trials

525 Total Patients Enrolled

Frequently Asked Questions

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

Is there currently an opportunity to enroll in this medical trial?

"Clinicaltrials.gov's records confirm this trial is presently searching for participants, having been originally posted on June 7th 2018 and recently modified on November 19 2022."

Answered by AI

Has Vicineum been granted clearance by the FDA?

"Vicineum has only been validated in Phase 1 trials, so its risk profile is assessed as a '1' on the Power scale. This indicates that while there may be some evidence of efficacy, safety data remains limited."

Answered by AI

How many participants have been registered for this research endeavor?

"That is accurate. According to clinicaltrials.gov, this medical trial was first advertised on June 7th 2018 and has been actively looking for participants since then. The study requires 40 people at a single centre of operation."

Answered by AI

In which cases is Vicineum typically prescribed?

"Vicineum is a beneficial form of treatment for individuals suffering from unresectable stage III non-small cell lung cancer, untried metastatic ureteral carcinoma, and other forms of this disease."

Answered by AI

What other experiments have been conducted that involve the use of Vicineum?

"At the current moment, 333 clinical trials for Vicineum are underway with 52 of them in Phase 3. While some locations to try this medication can be found in Cordoba, Texas specifically, a total of 12952 sites worldwide have begun testing it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

Vladimir Valera Romero, M.D. Ph.D 2018. "Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03258593.