Bladder CancerPhase 1TRIO BladderNCT04073160
TRIO Bladder: A Study of Durvalumab Plus Tremelimumab Followed by Concurrent Durvalumab Plus Bladder Radiation in Muscle-Invasive Bladder Cancer
A Phase 1 study testing Tremelimumab, Durvalumab and Bladder radiation in people with Bladder Cancer, run by Daniel George, MD at 1 site in United States.
Trial summary
The purpose of this study is to describe the safety and tolerability of Durvalumab plus Tremelimumab followed by concurrent Durvalumab plus bladder radiation in patients with localized muscle invasive urothelial carcinoma of the bladder, who are either Decipher-Non-Basal OR Decipher-Basal and cisplatin-ineligible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Tremelimumab, Durvalumab and Bladder radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2020to Jan 2026
- Phase
- Phase 1
- 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
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years
- Histologically or cytologically confirmed urothelial carcinoma of the bladder. Non-urothelial histologies and upper tract disease are excluded.
- Has clinical stage T2-T4b, N0-3, M0 urothelial carcinoma
- DECIPHER-Non-basal (Group A) OR DECIPHER-Basal but cisplatin-ineligible (Group B)
- Cisplatin-ineligible based on ≥1 of the following:
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- CrCl <60 ml/min
- Grade 2 hearing loss or peripheral neuropathy
- ECOG performance status of 2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Life expectancy of at least 12 weeks
- Body weight >30kg
- Adequate normal organ and marrow function as defined below:
- Hemoglobin ≥ 8.0 g/dL and asymptomatic
- Absolute neutrophil count (ANC ≥1.5 x 109/L)
- Platelet count ≥100 x 109/L
- Serum bilirubin ≤ 1.5 x Institutional Upper Limit of Normal (ULN) (Note: This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.)
- AST/SGOT and ALT/SGPT ≤ 2.5 x ULN
- Measured creatinine clearance (CL) >30 mL/min
- Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they meet the requirements below.
- Women < 45 years of age would be considered post-menopausal if they underwent surgical sterilization (bilateral oophorectomy or hysterectomy.
- Women 45 to <50 years of age would be considered post-menopausal if they have been amenorrheic for 18 months or more following cessation of exogenous hormonal treatments, if they have a documented follicle-stimulating hormone levels in the post-menopausal range (> 40 mlU/mL) or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, if they have a documented follicle-stimulating hormone levels in the post-menopausal range (> 40 mlU/mL) or underwent surgical sterilization (bilateral oophorecomy, bilateral salpingectomy or hysterectomy).
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Subjects must not have any of the following:
- Prior systemic chemotherapy for bladder cancer
- Any prior treatment with CTLA-4, including tremelimumab PD-1 or PD-L1 including durvalumab checkpoint inhibitors
- Administration of an investigational therapeutic within 28 days prior to Cycle 1, Day 1
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug.
- Prior pelvic radiation that precludes bladder radiation
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- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Prior cystectomy
- 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
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Duke Principal Investigator.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Duke Principal Investigator.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of allogenic stem cell transplant
- History of active primary immunodeficiency
- Active infection including, clinical evidence of active tuberculosis (cough >2 weeks' duration, fevers, night sweats, weight loss, and/or abnormal lung imaging), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Receipt of live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: Patients, if enrolled, should not receive live vaccine whilst receiving durvalumab or tremelimumab and up to 30 days after the last dose of durvalumab or tremelimumab.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: TRIO Bladder: A Phase Ib Study of Durvalumab (MEDI 4736) Plus Tremelimumab Followed by Concurrent Durvalumab Plus Bladder Radiation, Based on Molecular Subtypes in Muscle-Invasive Bladder Cancer
The purpose of this study is to describe the safety and tolerability of Durvalumab plus Tremelimumab followed by concurrent Durvalumab plus bladder radiation in patients with localized muscle invasive urothelial carcinoma of the bladder, who are either Decipher-Non-Basal OR Decipher-Basal and cisplatin-ineligible. Eligible subjects will receive 2 cycles of Durvalumab plus Tremelimumab followed by imaging and cystoscopy. Subjects whose cancer responds or is stable will receive a combination of 2 cycles of Durvalumab plus 6.5 weeks of radiation to the bladder followed by imaging and a TURBT. Subjects whose cancer continues to respond and meets certain criteria will continue to receive Durvalumab for up to 12 months from initial dose or until the cancer recoccurs or progresses, whichever occurs earlier. During this time, subjects may also receive intravesicular therapy if clinically indicated. Subjects will be followed for 5 years from initial dose.
- Conditions
- Bladder Cancer
- Being tested
- Tremelimumab, Durvalumab, Bladder radiation, Intravesicular Therapy
- Keywords
- Muscle-invasive bladder cancer, Decipher bladder test, Durvalumab, Tremelimumab, Bladder radiation, Urothelial carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Tremelimumab will be administered intravenously at a dose of 75 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.
DurvalumabDrug
Also called Imfinzi
Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.
Eligible subjects may go on to receive a combination of durvalumab and bladder radiation during cycles 3 and 4. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 3 day 1 and cycle 4 day 1.
At the completion of radiation, eligible subjects may continue to receive durvalumab for a maximum of one year from the date of their initial dose. Durvalumab will be administered intravenously at a dose of 1500 mg on the first day of each cycle.
Bladder radiationRadiation
During the durvalumab cycles 3 and 4, eligible subjects will receive 6.5 weeks of radiation to the bladder. Radiation will be administered at a dose of 64 Gy in daily 2 Gy fractions.
Intravesicular TherapyDrug
Subjects will receive intravesicular therapy, if clinically indicated during cycles 5 and beyond of durvalumab administration. Intravesicular therapy will consist of BCG, gemcitabine, mitomycin or a similar drug, depending on institutional standards and treating provider's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Decipher Bladder test subtype non-basal | Experimental | Subjects with localized muscle invasive urothelial carcinoma of the bladder, whose tumor is Decipher Bladder test subtype non-basal Receives: Drug: Tremelimumab; Drug: Durvalumab; Radiation: Bladder radiation; Drug: Intravesicular Therapy |
| Decipher Bladder test subtype basal and cisplatin-ineligible | Experimental | Subjects with localized muscle invasive urothelial carcinoma of the bladder, whose tumor is Decipher Bladder test subtype basal and the subject is cisplatin-ineligible Receives: Drug: Tremelimumab; Drug: Durvalumab; Radiation: Bladder radiation; Drug: Intravesicular Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Measured: Up to 90 days after the last dose of study drug(s)
Incidence of serious adverse events
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Measured: Up to 90 days after the last dose of study drug(s)
Incidence of adverse events of special interest
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Measured: Up to 90 days after the last dose of study drug(s)
Incidence of adverse events leading to study drug discontinuation
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Measured: Up to 90 days after the last dose of study drug(s)
Incidence of deaths
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Measured: Up to 90 days after the last dose of study drug(s)
Secondary outcomes (5)
2-year disease-free survival (DFS) for Decipher test sub-type basal vs. Decipher test sub-type non-basal
2-year disease-free survival (DFS) for Decipher test sub-type basal vs. Decipher test sub-type non-basal
Measured: 2 years
Pathologic complete response rate on post-duravalumab/radiation TURBT
Proportion of subjects with a pathologic complete response rate on post-duravalumab/radiation TURBT
Measured: Cycle 4 Day 21
Rate of salvage cystectomy
Proportion of subjects undergoing a salvage cystectomy after discontinuing study drug(s)
Measured: 5 years
5-year disease-free survival (DFS)
Proportion of subjects remaining disease-free at 5 years
Measured: 5 years
5-year overall survival (OS)
Proportion of subjects alive at 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study startJun 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Study will not be completed. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel George, MD
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Daniel George, MD, Duke University
- Investigators
- Tian Zhang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073160
- Sponsor's protocol ID
- Pro00102352
- Acronym
- TRIO Bladder
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2019
- Last updated
- 7 Jul 2020
- Results posted
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIO Bladder: A Phase Ib Study of Durvalumab (MEDI 4736) Plus Tremelimumab Followed by Concurrent Durvalumab Plus Bladder Radiation, Based on Molecular Subtypes in Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04073160
- Acronym / sponsor ID
- TRIO Bladder / Pro00102352
- Conditions
- Bladder Cancer
- Keywords
- Muscle-invasive bladder cancer, Decipher bladder test, Durvalumab, Tremelimumab, Bladder radiation, Urothelial carcinoma of the bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will not be completed. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daniel George, MDUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 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.
The purpose of this study is to describe the safety and tolerability of Durvalumab plus Tremelimumab followed by concurrent Durvalumab plus bladder radiation in patients with localized muscle invasive urothelial carcinoma of the bladder, who are either Decipher-Non-Basal OR Decipher-Basal and cisplatin-ineligible. Eligible subjects will receive 2 cycles of Durvalumab plus Tremelimumab followed by imaging and cystoscopy. Subjects whose cancer responds or is stable will receive a combination of 2 cycles of Durvalumab plus 6.5 weeks of radiation to the bladder followed by imaging and a TURBT. Subjects whose cancer continues to respond and meets certain criteria will continue to receive Durvalumab for up to 12 months from initial dose or until the cancer recoccurs or progresses, whichever occurs earlier. During this time, subjects may also receive intravesicular therapy if clinically indicated. Subjects will be followed for 5 years from initial dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decipher Bladder test subtype non-basal | Experimental | Drug: Tremelimumab, Drug: Durvalumab, Radiation: Bladder radiation, Drug: Intravesicular TherapySubjects with localized muscle invasive urothelial carcinoma of the bladder, whose tumor is Decipher Bladder test subtype non-basal |
| Decipher Bladder test subtype basal and cisplatin-ineligible | Experimental | Drug: Tremelimumab, Drug: Durvalumab, Radiation: Bladder radiation, Drug: Intravesicular TherapySubjects with localized muscle invasive urothelial carcinoma of the bladder, whose tumor is Decipher Bladder test subtype basal and the subject is cisplatin-ineligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years
- Histologically or cytologically confirmed urothelial carcinoma of the bladder. Non-urothelial histologies and upper tract disease are excluded.
- Has clinical stage T2-T4b, N0-3, M0 urothelial carcinoma
- DECIPHER-Non-basal (Group A) OR DECIPHER-Basal but cisplatin-ineligible (Group B)
Key exclusion criteria (37 listed)
- Prior systemic chemotherapy for bladder cancer
- Any prior treatment with CTLA-4, including tremelimumab PD-1 or PD-L1 including durvalumab checkpoint inhibitors
- Administration of an investigational therapeutic within 28 days prior to Cycle 1, Day 1
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug.
- Prior pelvic radiation that precludes bladder radiation
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 |
|---|---|---|
| TremelimumabTremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Tremelimumab will be administered intravenously at a dose of 75 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long. | Drug | Decipher Bladder test subtype basal and cisplatin-ineligible, Decipher Bladder test subtype non-basal |
| DurvalumabAlso: ImfinziTremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long. Eligible subjects may go on to receive a combination of durvalumab and bladder radiation during cycles 3 and 4. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 3 day 1 and cycle 4 day 1. At the completion of radiation, eligible subjects may continue to receive durvalumab for a maximum of one year from the date of their initial dose. Durvalumab will be administered intravenously at a dose of 1500 mg on the first day of each cycle. | Drug | Decipher Bladder test subtype basal and cisplatin-ineligible, Decipher Bladder test subtype non-basal |
| Bladder radiationDuring the durvalumab cycles 3 and 4, eligible subjects will receive 6.5 weeks of radiation to the bladder. Radiation will be administered at a dose of 64 Gy in daily 2 Gy fractions. | Radiation | Decipher Bladder test subtype basal and cisplatin-ineligible, Decipher Bladder test subtype non-basal |
| Intravesicular TherapySubjects will receive intravesicular therapy, if clinically indicated during cycles 5 and beyond of durvalumab administration. Intravesicular therapy will consist of BCG, gemcitabine, mitomycin or a similar drug, depending on institutional standards and treating provider's discretion. | Drug | Decipher Bladder test subtype basal and cisplatin-ineligible, Decipher Bladder test subtype non-basal |
Primary outcome
Incidence of adverse events
Time frame: Up to 90 days after the last dose of study drug(s)
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Incidence of serious adverse events
Time frame: Up to 90 days after the last dose of study drug(s)
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Incidence of adverse events of special interest
Time frame: Up to 90 days after the last dose of study drug(s)
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Incidence of adverse events leading to study drug discontinuation
Time frame: Up to 90 days after the last dose of study drug(s)
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
Incidence of deaths
Time frame: Up to 90 days after the last dose of study drug(s)
To describe the safety and tolerability of durvalumab plus tremelimumab followed by concurrent durvalumab plus bladder radiation in patients as assessed by CTCAE version 5.0.
5 secondary outcomes
2-year disease-free survival (DFS) for Decipher test sub-type basal vs. Decipher test sub-type non-basal
Time frame: 2 years
Pathologic complete response rate on post-duravalumab/radiation TURBT
Time frame: Cycle 4 Day 21
Rate of salvage cystectomy
Time frame: 5 years
5-year disease-free survival (DFS)
Time frame: 5 years
5-year overall survival (OS)
Time frame: 5 years
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 7 Jul 2020.
- 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.
Tian Zhang, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tremelimumab, Durvalumab and Bladder radiation in people with Bladder Cancer, run by Daniel George, MD at 1 site 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 24 inclusion and 37 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of adverse events (time frame: Up to 90 days after the last dose of study drug(s)). The study lists 5 primary outcomes in all. 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 7 Jul 2020.