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PD-L1 Inhibitor

Vactosertib + Durvalumab for Bladder Cancer

Phase 2
Waitlist Available
Led By Lawrence Fong, MD
Research Sponsored by MedPacto, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ and marrow function as defined
Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall study period up to 3years
Awards & highlights

Study Summary

This trial will test whether adding vactosertib to durvalumab will improve response rates in patients with urothelial cancers who haven't responded to anti-PD-1/PD-L1 treatment.

Who is the study for?
This trial is for adults with advanced urothelial bladder cancer that didn't respond to previous anti-PD-1/PD-L1 treatments. Participants must be relatively healthy (ECOG 0 or 1), have a life expectancy of at least 12 weeks, and weigh over 30 kg. They should not have other cancers, serious illnesses like heart failure, active infections including hepatitis B/C or HIV, unresolved toxic effects from past cancer therapy (except hair loss or skin changes), or a history of organ transplant.Check my eligibility
What is being tested?
The study is testing the combination of vactosertib with durvalumab in patients whose urothelial carcinoma has not improved after treatment with PD-1/PD-L1 inhibitors. It's an open-label Phase 2 trial aiming to see if this combo can increase the overall response rate—meaning it helps reduce the size of tumors.See study design
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, fatigue, digestive issues like nausea and diarrhea, skin problems like rash and itching, potential liver function changes, and increased risk for infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow are working well.
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My cancer came back after platinum-based treatment or I can't have platinum therapy.
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I have previously received anti-PD-(L)1 therapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer originates from the urinary system and cannot be removed by surgery.
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My cancer can be measured by scans.
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My body weight is over 30 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall study period up to 3years
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall study period up to 3years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Best Response
Duration of Response
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vactosertib+DurvalumabExperimental Treatment1 Intervention
Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,194 Total Patients Enrolled
MedPacto, Inc.Lead Sponsor
10 Previous Clinical Trials
447 Total Patients Enrolled
Lawrence Fong, MDPrincipal InvestigatorUniversity of California, San Francisco
10 Previous Clinical Trials
252 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04064190 — Phase 2
Bladder Cancer Research Study Groups: Vactosertib+Durvalumab
Bladder Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04064190 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04064190 — Phase 2

Frequently Asked Questions

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

For what medical conditions is Vactosertib(TEW-7197)/ Durvalumab most beneficial?

"Patients with unresectable stage III non-small cell lung cancer, as well as those diagnosed with untreated metastatic ureteral urothelial carcinoma can benefit from the combination of Vactosertib (TEW-7197) and Durvalumab."

Answered by AI

Are there still openings to join this clinical research?

"This trial has already finished recruitment. The original posting on October 15th 2021 was the most recently updated to September 22nd, 2021. For those seeking other studies involving urothelial carcinoma recurrent or Vactosertib (TEW-7197)/ Durvalumab, there are presently 2506 and 343 trials respectively actively enrolling participants."

Answered by AI

Has the FDA given their stamp of approval to Vactosertib(TEW-7197)/ Durvalumab?

"Based on our team's assessment, Vactosertib(TEW-7197)/ Durvalumab received a rating of 2 due to the lack of efficacy data in Phase 2 trials. However, there is some evidence that suggests this drug is safe for use."

Answered by AI

What is the total population size for this research endeavor?

"At this juncture, the trial is not in need of patients. The first announcement was made on October 15th 2021 and it's been revised most recently on September 22nd 2021. For those looking for alternate studies relating to urothelial carcinoma recurrent there are 2506 clinical trials recruiting participants; 343 studies concerning Vactosertib (TEW-7197)/Durvalumab are also actively seeking candidates."

Answered by AI

Are there any records of collaborative research between Vactosertib(TEW-7197) and Durvalumab?

"Presently, there are 343 active clinical trials researching the efficacy of combining Vactosertib(TEW-7197) and Durvalumab. This includes 52 Phase 3 studies mostly situated in Cordoba, Texas but with a total of 12969 sites conducting such research across the world."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
2021. "Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04064190.
~14 spots leftby Apr 2025
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