TriangleNCT03732677 · CITED IN SOURCE DOCUMENTS
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-17
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event
Proportion of Patients Who Undergo Cystectomy
Overall Survival
Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.
Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion: * Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology * Patients must be planning to undergo a radical cystectomy * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC * ECOG performance status of 0 or 1 * Must have a life expectancy of at least 12 weeks at randomization Exclusion: * Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening. * Prior pelvic radiotherapy treatment within 2 years of randomization to study * Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin \[BCG\]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies. * Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, 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 (eg, CT scan premedication) * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. * Uncontrolled intercurrent illness * Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency
- healthy Volunteers
- false
- maximum Age
- 130 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Chemotherapy + Durvalumab
- intervention Names
- Drug: Durvalumab
- Drug: Cisplatin
- Drug: Gemcitabine
- label
- Arm 1
- type
- EXPERIMENTAL
- description
- Chemotherapy alone
- intervention Names
- Drug: Cisplatin
- Drug: Gemcitabine
- label
- Arm 2
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Arm 1
- description
- Anti- PD-L1 Antibody
- name
- Durvalumab
- type
- DRUG
- arm Group Labels
- Arm 1
- Arm 2
- description
- Chemotherapy Agent
- name
- Cisplatin
- type
- DRUG
- arm Group Labels
- Arm 1
- Arm 2
- description
- Chemotherapy agent
- name
- Gemcitabine
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1063
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.
- measure
- Pathologic Complete Response (pCR) Rates at Time of Cystectomy
- time Frame
- Up to 6 months
- description
- EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first
- measure
- Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
- time Frame
- Up to 48 months
- secondary Outcomes
- description
- EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion
- measure
- Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event
- time Frame
- Up to 24 months
- description
- The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.
- measure
- Proportion of Patients Who Undergo Cystectomy
- time Frame
- Up to 6 months
- description
- OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)
- measure
- Overall Survival
- time Frame
- Up to 65 months
- description
- MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first
- measure
- Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.
- time Frame
- Up to 48 months
- description
- DSS is defined as the time from the date of randomization until death due to bladder cancer
- measure
- Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.
- time Frame
- Up to 48 months
- description
- Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.
- measure
- Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)
- time Frame
- Up to 12 months
Full study description
- brief Summary
- A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
Source references
- references
- citation
- Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, Vu TQ, Antonuzzo L, Wiechno P, Atduev V, Kann AG, Kim TH, Suarez C, Chang CH, Roghmann F, Ozguroglu M, Eigl BJ, Oliveira N, Buchler T, Gadot M, Zakharia Y, Armstrong J, Gupta A, Hois S, van der Heijden MS; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024 Nov 14;391(19):1773-1786. doi: 10.1056/NEJMoa2408154. Epub 2024 Sep 15.
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Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice