Clinical trial · Interventional
Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
A Phase 2 Study of TGF-β Inhibition (Vactosertib) with Anti-PD-L1 (Durvalumab) in Patients with Advanced or Recurrent Urothelial Carcinoma Failing to Achieve Response with Checkpoint Inhibition
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Changing trial strategy
Summary
Brief summary (as posted)
This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Urothelial Carcinoma Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vactosertib(TEW-7197)/ Durvalumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vactosertib+Durvalumab
- description
- Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.
- interventionNames
- Drug: Vactosertib(TEW-7197)/ Durvalumab
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 12months
- description
- ORR by RECIST version 1.1
Secondary outcomes (7)
- measure
- Time to Tumor Response
- timeFrame
- Overall study period up to 3years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment 2. Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra. 3. Prior anti-PD-(L)1 treatment. 4. Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI. 5. Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy. 6. Adequate organ and marrow function as defined 7. Must have a life expectancy of at least 12 weeks. 8. Body weight \> 30 kg Exclusion Criteria: 1. History of allogeneic organ transplantation. 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure . 4. History of another primary malignancy 5. History of leptomeningeal carcinomatosis. 6. History of active primary immunodeficiency. 7. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus . 8. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
References
Publications (0)
Data not yet available