Description:
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
Title
- Brief Title: Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
- 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
Clinical Trial IDs
- ORG STUDY ID:
MP-VAC-202 (ION-03)
- NCT ID:
NCT04064190
Conditions
- Urothelial Carcinoma Recurrent
- Advanced Urothelial Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Vactosertib(TEW-7197)/ Durvalumab | | Vactosertib+Durvalumab |
Purpose
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
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Vactosertib+Durvalumab | Experimental | Vactosertib will be administered in combination with standard dose of durvalumab every four weeks. | - Vactosertib(TEW-7197)/ Durvalumab
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Response Rate |
Time Frame: | 12months |
Safety Issue: | |
Description: | ORR by RECIST version 1.1 |
Secondary Outcome Measures
Measure: | Time to Tumor Response |
Time Frame: | Overall study period up to 3years |
Safety Issue: | |
Description: | TTR by RECIST version 1.1 and iRECIST |
Measure: | Best Response |
Time Frame: | Overall study period up to 3years |
Safety Issue: | |
Description: | Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST |
Measure: | Duration of Response |
Time Frame: | Overall study period up to 3years |
Safety Issue: | |
Description: | DoR by RECIST version 1.1 and iRECIST |
Measure: | Progression Free Survival |
Time Frame: | 6-month/ 12-month |
Safety Issue: | |
Description: | PFS by RECIST version 1.1 and iRECIST |
Measure: | Overall survival |
Time Frame: | 12month |
Safety Issue: | |
Description: | OS by RECIST version 1.1 and iRECIST |
Measure: | Tumor-specific immune responses |
Time Frame: | Overall study period up to 3years |
Safety Issue: | |
Description: | 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 |
Measure: | Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] |
Time Frame: | Overall study period up to 3years |
Safety Issue: | |
Description: | To assess safety and tolerability of vactosertib administered concurrent with Durvalumab in patients with urothelial carcinoma failing checkpoint inhibition |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | MedPacto, Inc. |
Last Updated
September 9, 2020