For Healthcare Professionals

Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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


EXCLUSION CRITERIA

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 .
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Urothelial Carcinoma Recurrent,Advanced Urothelial Carcinoma

Age (in years)

18+

Phase

Phase 2

Participants needed

48

Est. Completion Date

Dec 30, 2024

Treatment type

Interventional


Sponsor

MedPacto, Inc.

ClinicalTrials.gov identifier

NCT04064190

Study number

MP-VAC-202

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