Muscle-Invasive Bladder Cancer (MIBC)Phase 4SERENENCT07876817
A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer Cle-Invasive
A Phase 4 study testing Durvalumab, Gemcitabine and Cisplatin in people with Muscle-Invasive Bladder Cancer (MIBC), run by AstraZeneca.
Trial summary
This is a Phase 4, Single Arm Study To Assess The Safety and tolerability of Perioperative Durvalumab in Combination with Neoadjuvant Gemcitabine Plus Cisplatin Treatment Followed by radical cystectomy and Durvalumab alone as Treatment in Indian Patients with Muscle-Invasive Bladder Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Cancer (MIBC)
- What is being tested?
- Durvalumab, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 31 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- * Participant must be ≥18 years of age inclusive.
- * Patients with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder.
- * Patients with transitional cell and mixed transitional/non-transitional cell histologies.
- * Patients with clinical tumour stage T2-T4aN0/1M0.
- * Medically fit for treatment with neoadjuvant therapy prior to radical cystectomy.
- * Medically fit to undergo a radical cystectomy at time of enrolment.
Show all 15Show fewer
- * Have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC.
- * Body weight >30 kg.
- * Male participants must use a condom plus an additional contraceptive method.
- * Female participants must be postmenopausal or have evidence of nonchildbearing status.
- * Capable of giving signed informed consent.
- * Must have a life expectancy of at least 12 weeks at Enrollement.
- * Adequate bone marrow function (Haemoglobin ≥ 9.0 g/dL, Absolute neutrophil count ≥ 1.5 × 10^9/L, Platelet count ≥100 x 10^9/L).
- * Adequate renal function (Creatinine clearance (CrCL) > 40 mL/min).
- * Adequate hepatic function (Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤2.5 x ULN).
Who cannot join
- * Evidence of lymph node (N2-3) or metastatic TCC/UC (M1), extravesical TCC/UC (T4b), or primary non-bladder TCC/UC.
- * Any unresolved toxicity Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, and specified laboratory values.
- * Major surgical procedure within 2 weeks of starting study treatment.
- * Requirement for a nephroureterectomy at the time of enrollement for tumour of the mid ureter, renal pelvis, or collecting system.
- * Inoperable tumour(s) with fixation to the pelvic wall on clinical exam.
- * History of allogeneic organ transplantation that requires use of immunosuppressive agents.
Show all 27Show fewer
- * Active or previously documented autoimmune or inflammatory disorders.
- * Uncontrolled intercurrent illness.
- * History of another primary malignancy, with exceptions.
- * Resting ECG indicating uncontrolled, potentially reversible cardiac conditions.
- * History of active primary immunodeficiency.
- * History of a myocardial infarction within 6 months prior to enrollement.
- * Any clinically significant systemic disease or medical condition that could interfere with the study.
- * Any clinically significant systemic disease or medical condition that could interfere with the study.
- * HIV positive.
- * Any medical contraindication to platinum (Cisplatin)-based doublet chemotherapy.
- * Concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment.
- * Prior exposure to immune-mediated therapy (with exclusion of BCG).
- * Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab, with exceptions.
- * Prior pelvic radiotherapy treatment within 2 years of enrollement to study.
- * Receipt of live attenuated vaccine within 30 days before the first dose of study treatment.
- * Concomitant use of known strong or moderate CYP3A inhibitors.
- * Concomitant use of known strong or moderate CYP3A inducers.
- * Participation in another clinical study with a study intervention administered in the last 30 days.
- * Involvement in the planning and/or conduct of the study.
- * Involvement in the planning and/or conduct of the study.
- * For females only - currently pregnant or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer (MIBC).
This is a Phase 4, Single Arm Study To Assess The Safety and tolerability of Perioperative Durvalumab in Combination with Neoadjuvant Gemcitabine Plus Cisplatin Treatment Followed by radical cystectomy and Durvalumab alone as Treatment in Indian Patients with Muscle-Invasive Bladder Cancer. It is to be conducted in compliance with a condition of approval specified by Health Authority of India following the addition of this indication to the approved prescribing information. A phase IV clinical trial to Asses the safety profile of this regimen in patients from India and subsequently, any regulatory action resulting from the review should be complied.
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Being tested
- Durvalumab, Gemcitabine, Cisplatin
- Keywords
- Muscle-Invasive Bladder Cancer, MIBC, Durvalumab, Gemcitabine, Cisplatin, Neoadjuvant Therapy, Adjuvant Therapy, Perioperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called IMFINZI
Solution for IV infusion, 1500 mg/vial. Administered at 1500 mg IV every 3 weeks during the neoadjuvant phase and every 4 weeks during the adjuvant phase.
GemcitabineDrug
Solution for IV infusion. Administered at 1000 mg/m² on Day 1 and Day 8 of each 21-day neoadjuvant cycle.
CisplatinDrug
Solution for IV infusion. Administered at 70 mg/m² on Day 1 of each 21-day neoadjuvant cycle. A split dose of 35 mg/m² on Days 1 and 8 may be used for patients with borderline renal function.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment (Durvalumab + Gemcitabine + Cisplatin) | Experimental | On Day 1 of each cycle, Durvalumab 1500 mg IV followed by Cisplatin 70 mg/m2 and gemcitabine 1000 mg/m2; on Day 8 Gemcitabine 1000 mg/m2; given every 21 days for 4 cycles. For patients with borderline renal function, a split dose of Cisplatin (35 mg/m2 on Days 1 and 8) may be used. After radical cystectomy Durvalumab 1500 mg IV every 4 weeks (Q4W) for up to 8 cycles (29 weeks). Receives: Drug: Durvalumab; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing adverse events (AEs)
The number of subjects experiencing adverse events (AEs), with categorization of AEs by system organ class, preferred term, and CTCAE grade.
Measured: Throughout the study, up to approximately 66 weeks
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Adverse Drug Reactions (ADRs)
Percentage of Subjects with SAEs, TEAEs \& with ADRs during the study.
Measured: Throughout the study, up to approximately 66 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder Cancer (MIBC)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876817
- Sponsor's protocol ID
- D933RL00001
- Acronym
- SERENE
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer (MIBC).
- ClinicalTrials.gov ID
- NCT07876817
- Acronym / sponsor ID
- SERENE / D933RL00001
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Keywords
- Muscle-Invasive Bladder Cancer, MIBC, Durvalumab, Gemcitabine, Cisplatin, Neoadjuvant Therapy, Adjuvant Therapy, Perioperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 15 Oct 2026 (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 a Phase 4, Single Arm Study To Assess The Safety and tolerability of Perioperative Durvalumab in Combination with Neoadjuvant Gemcitabine Plus Cisplatin Treatment Followed by radical cystectomy and Durvalumab alone as Treatment in Indian Patients with Muscle-Invasive Bladder Cancer. It is to be conducted in compliance with a condition of approval specified by Health Authority of India following the addition of this indication to the approved prescribing information. A phase IV clinical trial to Asses the safety profile of this regimen in patients from India and subsequently, any regulatory action resulting from the review should be complied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment (Durvalumab + Gemcitabine + Cisplatin) | Experimental | Drug: Durvalumab, Drug: Gemcitabine, Drug: CisplatinOn Day 1 of each cycle, Durvalumab 1500 mg IV followed by Cisplatin 70 mg/m2 and gemcitabine 1000 mg/m2; on Day 8 Gemcitabine 1000 mg/m2; given every 21 days for 4 cycles. For patients with borderline renal function, a split dose of Cisplatin (35 mg/m2 on Days 1 and 8) may be used. After radical cystectomy Durvalumab 1500 mg IV every 4 weeks (Q4W) for up to 8 cycles (29 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- * Participant must be ≥18 years of age inclusive.
- * Patients with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder.
- * Patients with transitional cell and mixed transitional/non-transitional cell histologies.
- * Patients with clinical tumour stage T2-T4aN0/1M0.
- * Medically fit for treatment with neoadjuvant therapy prior to radical cystectomy.
Key exclusion criteria (27 listed)
- * Evidence of lymph node (N2-3) or metastatic TCC/UC (M1), extravesical TCC/UC (T4b), or primary non-bladder TCC/UC.
- * Any unresolved toxicity Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, and specified laboratory values.
- * Major surgical procedure within 2 weeks of starting study treatment.
- * Requirement for a nephroureterectomy at the time of enrollement for tumour of the mid ureter, renal pelvis, or collecting system.
- * Inoperable tumour(s) with fixation to the pelvic wall on clinical exam.
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 |
|---|---|---|
| DurvalumabAlso: IMFINZISolution for IV infusion, 1500 mg/vial. Administered at 1500 mg IV every 3 weeks during the neoadjuvant phase and every 4 weeks during the adjuvant phase. | Drug | Neoadjuvant Treatment (Durvalumab + Gemcitabine + Cisplatin) |
| GemcitabineSolution for IV infusion. Administered at 1000 mg/m² on Day 1 and Day 8 of each 21-day neoadjuvant cycle. | Drug | Neoadjuvant Treatment (Durvalumab + Gemcitabine + Cisplatin) |
| CisplatinSolution for IV infusion. Administered at 70 mg/m² on Day 1 of each 21-day neoadjuvant cycle. A split dose of 35 mg/m² on Days 1 and 8 may be used for patients with borderline renal function. | Drug | Neoadjuvant Treatment (Durvalumab + Gemcitabine + Cisplatin) |
Primary outcome
Number of subjects experiencing adverse events (AEs)
Time frame: Throughout the study, up to approximately 66 weeks
The number of subjects experiencing adverse events (AEs), with categorization of AEs by system organ class, preferred term, and CTCAE grade.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Adverse Drug Reactions (ADRs)
Time frame: Throughout the study, up to approximately 66 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Muscle-Invasive Bladder Cancer (MIBC)
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruitingPhase 2
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
Bladder Cancer
Active, not recruitingPhase 2
Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC
Bladder Cancer
Active, not recruitingPhase 2
Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer
Muscle-Invasive Bladder Cancer (MIBC)
Active, not recruitingPhase 3
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
Muscle Invasive Bladder Cancer
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.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Durvalumab, Gemcitabine and Cisplatin in people with Muscle-Invasive Bladder Cancer (MIBC), run by AstraZeneca.
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 15 inclusion and 27 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing adverse events (AEs) (time frame: Throughout the study, up to approximately 66 weeks). 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 15 Oct 2026.