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Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

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ClinicalTrials.gov Identifier: NCT04064190
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedPacto, Inc.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Recurrent Advanced Urothelial Carcinoma Drug: Vactosertib(TEW-7197)/ Durvalumab Phase 2

Detailed Description:

This is a Phase 2, open-label, non-randomized, two-cohort multi center study with a safety run-in of 6 patients in Cohort 1. It is anticipated that a total of 48 patients will be enrolled.

Durvalumab will be administered with the standard regimen of 1500 mg intravenously (IV) every four weeks. Vactosertib will be administered at a dose of 300 mg PO BID for 5 days per week All treatment will be administered up to two years and the trial is anticipated to be completed over a period of 36 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 2, open label, non randomized single arm study with two cohorts and a safety run-in for first six patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vactosertib+Durvalumab
Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.
 Drug: Vactosertib(TEW-7197)/ Durvalumab
Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 12months ]
    ORR by RECIST version 1.1


Secondary Outcome Measures :
  1. Time to Tumor Response [ Time Frame: Overall study period up to 3years ]
    TTR by RECIST version 1.1 and iRECIST

  2. Best Response [ Time Frame: Overall study period up to 3years ]
    Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST

  3. Duration of Response [ Time Frame: Overall study period up to 3years ]
    DoR by RECIST version 1.1 and iRECIST

  4. Progression Free Survival [ Time Frame: 6-month/ 12-month ]
    PFS by RECIST version 1.1 and iRECIST

  5. Overall survival [ Time Frame: 12month ]
    OS by RECIST version 1.1 and iRECIST

  6. Tumor-specific immune responses [ Time Frame: Overall study period up to 3years ]
    tumor-specific immune responses within on-therapy biopsies measured by increased T cell infiltration and increased IFN-λ signature. and the correlation with outcome as measured by ORR, TTR, DoR, PFS and OS

  7. Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] [ Time Frame: Overall study period up to 3years ]
    To assess safety and tolerability of vactosertib administered concurrent with Durvalumab in patients with urothelial carcinoma failing checkpoint inhibition


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064190


Contacts
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Contact: Sun Jin Hwang, MD +82 2 6938 0206 sunjin.hwang@medpacto.com

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94158
Contact: Larry Fong, Dr         
United States, New York
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Contact: Gurkamal Chatta, Dr.         
Sponsors and Collaborators
MedPacto, Inc.
AstraZeneca
Investigators
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Principal Investigator: Lawrence Fong, MD University of California, San Francisco
More Information
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Responsible Party: MedPacto, Inc.
ClinicalTrials.gov Identifier: NCT04064190    
Other Study ID Numbers: MP-VAC-202 (ION-03)
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents