Urothelial Carcinoma RecurrentPhase 2NCT04064190
Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
A Phase 2 study testing Vactosertib(TEW-7197)/ Durvalumab in people with Urothelial Carcinoma Recurrent and Advanced Urothelial Carcinoma, run by MedPacto, Inc. at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Recurrent, Advanced Urothelial Carcinoma
- What is being tested?
- Vactosertib(TEW-7197)/ Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Dec 2019to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University of California San Francisco
San Francisco, California, 94158
About this study
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
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
Read the 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.
- Being tested
- Vactosertib(TEW-7197)/ Durvalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vactosertib(TEW-7197)/ DurvalumabDrug
Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vactosertib+Durvalumab | Experimental | Vactosertib will be administered in combination with standard dose of durvalumab every four weeks. Receives: Drug: Vactosertib(TEW-7197)/ Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
ORR by RECIST version 1.1
Measured: 12months
Secondary outcomes (7)
Time to Tumor Response
TTR by RECIST version 1.1 and iRECIST
Measured: Overall study period up to 3years
Best Response
Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST
Measured: Overall study period up to 3years
Duration of Response
DoR by RECIST version 1.1 and iRECIST
Measured: Overall study period up to 3years
Progression Free Survival
PFS by RECIST version 1.1 and iRECIST
Measured: 6-month/ 12-month
Overall survival
OS by RECIST version 1.1 and iRECIST
Measured: 12month
Tumor-specific immune responses
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
Measured: Overall study period up to 3years
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
To assess safety and tolerability of vactosertib administered concurrent with Durvalumab in patients with urothelial carcinoma failing checkpoint inhibition
Measured: Overall study period up to 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start13 Dec 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Changing trial strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedPacto, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Lawrence Fong, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064190
- Sponsor's protocol ID
- MP-VAC-202
- Status last verified
- Dec 2024
- First submitted
- 15 Aug 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04064190
- Acronym / sponsor ID
- MP-VAC-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changing trial strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedPacto, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2, open label, non randomized single arm study with two cohorts and a safety run-in for first six patients
| Arm | Type | Receives |
|---|---|---|
| Vactosertib+Durvalumab | Experimental | Drug: Vactosertib(TEW-7197)/ DurvalumabVactosertib will be administered in combination with standard dose of durvalumab every four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vactosertib(TEW-7197)/ DurvalumabVactosertib (PO) in combination with Durvalumab (IV) every 4 weeks | Drug | Vactosertib+Durvalumab |
Primary outcome
Overall Response Rate
Time frame: 12months
ORR by RECIST version 1.1
7 secondary outcomes
Time to Tumor Response
Time frame: Overall study period up to 3years
Best Response
Time frame: Overall study period up to 3years
Duration of Response
Time frame: Overall study period up to 3years
Progression Free Survival
Time frame: 6-month/ 12-month
Overall survival
Time frame: 12month
Tumor-specific immune responses
Time frame: Overall study period up to 3years
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Time frame: Overall study period up to 3years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Fong, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vactosertib(TEW-7197)/ Durvalumab in people with Urothelial Carcinoma Recurrent and Advanced Urothelial Carcinoma, run by MedPacto, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.