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 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urothelial Carcinoma Recurrent Advanced Urothelial Carcinoma | Drug: Vactosertib(TEW-7197)/ Durvalumab | Phase 2 |
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 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, 2021 |
Estimated Primary Completion Date : | December 30, 2023 |
Estimated Study Completion Date : | December 30, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Vactosertib+Durvalumab
Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.
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Drug: Vactosertib(TEW-7197)/ Durvalumab
Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks |
- Overall Response Rate [ Time Frame: 12months ]ORR by RECIST version 1.1
- Time to Tumor Response [ Time Frame: Overall study period up to 3years ]TTR by RECIST version 1.1 and iRECIST
- Best Response [ Time Frame: Overall study period up to 3years ]Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST
- Duration of Response [ Time Frame: Overall study period up to 3years ]DoR by RECIST version 1.1 and iRECIST
- Progression Free Survival [ Time Frame: 6-month/ 12-month ]PFS by RECIST version 1.1 and iRECIST
- Overall survival [ Time Frame: 12month ]OS by RECIST version 1.1 and iRECIST
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment
- Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra.
- Prior anti-PD-(L)1 treatment.
- Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI.
- Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy.
- Adequate organ and marrow function as defined
- Must have a life expectancy of at least 12 weeks.
- Body weight > 30 kg
Exclusion Criteria:
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure .
- History of another primary malignancy
- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus .
- 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

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
Contact: Sunjin Hwang, MD | +82 2 6938 0206 | sunjin.hwang@medpacto.com |
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. |
Principal Investigator: | Lawrence Fong, MD | University of California, San Francisco |
Responsible Party: | MedPacto, Inc. |
ClinicalTrials.gov Identifier: | NCT04064190 |
Other Study ID Numbers: |
MP-VAC-202 |
First Posted: | August 21, 2019 Key Record Dates |
Last Update Posted: | September 24, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents |