Urothelial CancerPhase 2SAKK 06/17NCT03406650
Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer.
A Phase 2 study testing Neoadjuvant and adjuvant durvalumab in people with Urothelial Cancer, run by Swiss Cancer Institute at 17 sites in 2 countries.
Trial summary
The main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab, to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- What is being tested?
- Neoadjuvant and adjuvant durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 15 May 2018to 31 Jan 2025
- 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
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- Histologically proven urothelial cell carcinoma of the bladder, urethra or upper urinary tract (T2, T3, or T4a and ≤ N1 (defined as a solitary lymph node ≤ 2 cm in the greatest dimension), M0) and be considered suitable for curative multimodality treatment including surgery by a multidisciplinary tumor board. Cytological diagnosis is only allowed for upper tract urothelial carcinoma. In these cases tumor has to be documented by urography
- All histological subtypes eligible if urothelial carcinoma predominant (exception: small cell component)
- Age ≥ 18 years
- WHO performance status 0-1
- Bone marrow function: hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L
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- Hepatic function: bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN
- Renal function: estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m², according to CKD-EPI formula
- Cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiography (ECHO)
- Women with child-bearing potential are using effective contraception (for details of definition see 9.9), are not pregnant or lactating and agree not to become pregnant during trial treatment and during 90 days thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential
- Men agree not to father a child during trial treatment and during 90 days thereafter
- Body weight > 30kg.
Who cannot join
- Any pathological evidence of small-cell carcinoma component
- Presence of any distant metastasis
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years before registration, with the exception of adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer or low risk localized prostate cancer (T1-T2a, Gleason <7, PSA <10ng/ml)
- Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab
- Concurrent treatment with prednisone (or equivalent); except for the prophylactic medication before chemotherapy, treatment of acute hypersensitivity reactions or chronic treatment (initiated > 6 months prior to registration) at low dose (≤ 10 mg/day of prednisone or an equivalent corticosteroid)
- Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 28 days prior to registration
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- Current or prior use of immunosuppressive medication within 28 days prior to registration, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids
- Major surgical procedure within 28 days prior to registration
- Preexisting peripheral neuropathy (> grade 1)
- Uncontrolled diabetes mellitus
- 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 coordinating investigator
- Patients with celiac disease controlled by diet alone
- Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment
- History of allogeneic organ transplant
- Receipt of live attenuated vaccine within 30 days prior to registration. Note: Patients, if enrolled, should not receive live vaccine during trial treatment and up to 30 days after the last dose
- 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
- Any concurrent drug contraindicated for blocking the effect of durvalumab; this includes systemic corticosteroids, methotrexate, azathioprine, and tumor necrosis factor (TNF)-α blockers. Any concurrent drug contraindicated for use with the other trial drugs according to the locally approved product information
- Known hypersensitivity to cisplatin, gemcitabine or durvalumab or to any excipient
- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Switzerland15 sites
Kantonspital Aarau
Aarau, CH-5001
Kantonsspital Baden
Baden, CH-5404
Universitaetsspital Basel
Basel, 4031
Inselspital
Bern, 3010
Kantonsspital Graubünden
Chur, 7000
Spital Thurgau AG
Frauenfeld, CH-8500
Hopital Cantonal Universitaire de Geneve
Geneva, CH-1211
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, CH-1011
Luzerner Kantonsspital
Lucerne, 6000
Kantonsspital St. Gallen
Sankt Gallen, CH-9007
Kantonsspital Winterthur
Winterthur, 8401
Klinik Hirslanden - Onkozentrum Hirslanden
Zurich, 8032
OnkoZentrum Zürich
Zurich, 8038
City Hospital Triemli
Zurich, 8063
UniversitaetsSpital Zuerich
Zurich, 8091
Germany2 sites
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Urologische Universitätsklinik Essen
Essen, 45147
About this study
Official title: Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer. A Multicenter, Single-arm Phase II Trial
The main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab, to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival.
Read the detailed description
Despite optimal surgical management the prognosis for localized muscle invasive urothelial cancer (MIUC) is unfavorable with 5-year overall survival of around 45%.
According to international guidelines the use of cisplatin-based neoadjuvant chemotherapy is considered standard of care in all patients with localized MIUC with planned curative local treatment.
However, the benefit of neoadjuvant chemotherapy is limited and there is a clear medical need for improvement for this patient population.
Durvalumab has been tested in a phase I/II open-label study including patients with metastatic urothelial cancer (mUC).
The results demonstrated an overall response rate (RR) of 31% in 42 response-evaluable patients. The side effect profile was favorable with most common grade 1/2 AE representing fatigue (13%), diarrhea (10%) and decreased appetite (8%). Three patients (4.9%) had treatment related grade 3 AE's, no grade 4/5 events were noted.
The combination of cisplatin/gemcitabine chemotherapy with modern immune-checkpoint inhibition has been demonstrated to be feasible with demonstration of favorable immunomodulatory effects.
In view of these data it appears a logical step to apply these novel agents in the curative setting of neoadjuvant treatment.
The expected benefit of combining chemotherapy with durvalumab and to continue durvaluamb postoperatively might be twofold:
- to increase the response rate in the pre-operative setting and subsequently to increase the rate of pathologic complete remission (pT0) and to reduce risk of local recurrence
- to evoke durable systemic anti-cancer responses and subsequently to increase disease free- and overall survival and furthermore to induce antitumor immune response.
- Conditions
- Urothelial Cancer
- Being tested
- Neoadjuvant and adjuvant durvalumab
- Keywords
- muscle invasive urothelial cancer, cancer, immunotherapy, durvalumab, MEDI4736, adjuvant, neoadjuvant, radical cystectomy, bladder
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant and adjuvant durvalumabDrug
Also called MEDI4736
Neoadjuvant durvalumab 1500 mg q3w for 4 cycles Adjuvant durvalumab 1500 mg q4w for 10 cycles
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab in combination with standard therapy | Experimental | Combination of standard therapy consisting (4 cycles cisplatin/ gemcitabin followed by surgery) with 4 cycles of neoadjuvant durvalumab and 10 cycles of adjuvant durvalumab Receives: Drug: Neoadjuvant and adjuvant durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival (EFS)
The primary endpoint of the trial is Event-free survival (EFS) at 2 years after neoadjuvant trial treatment start.
Event-free survival is defined as the time from treatment start until one of the following events, whichever comes first:
- Progression during neoadjuvant treatment leading to inoperability
- Recurrence of locoregional disease after surgery
- Appearance of metastases at any localization
- Death Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a subsequent treatment, if any.
Measured: 2 years after treatment start
Secondary outcomes (9)
Event-free survival (EFS)
Event-free survival is defined as the time from treatment start until one of the following events, whichever comes first:
- Progression during neoadjuvant treatment leading to inoperability
- Recurrence of locoregional disease after surgery
- Appearance of metastases at any localization
- Death Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a subsequent treatment, if any.
Measured: at the occurrence of the event or latest 5 years after surgery
Recurrence-free survival (RFS) after R0 resection
RFS after R0 resection is defined as the time from surgery until one of the following events, whichever comes first:
- Recurrence of locoregional disease
- Appearance of metastases at any localization
- Death Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a subsequent treatment, if any.
This endpoint will only be calculated for patients in the R0 resection set.
Measured: at recurrence or latest 5 years after surgery
Overall survival (OS)
Overall survival is defined as the time from treatment start until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.
Measured: at death or latest 5 years after surgery
Quality of resection
The quality of resection will be assessed in the following way:
- Complete resection (R0) defined as free resection margins proved microscopically
- Completeness of the lymphadenectomy and surgery using the photo documentation and histopathology
- Postoperative complications will be assessed using the Clavien-Dindo classification
Measured: after surgery or the latest 20 weeks after registration
Pathological complete response rate (ypT0)
Pathological complete response (ypT0) is defined as no residual tumor in the surgical specimen. The proportion of patients with ypT0 will be calculated for patients in the resected patients set.
Measured: after surgery or the latest 20 weeks after registration
Pathological response rate (PaR) defined by pathological downstaging to ≤ypT1N0M0
Pathological response (PaR) is defined as pathological downstaging to ≤ ypT1N0M0. The proportion of patients with PaR will be calculated for patients in the resected patients set.
Measured: after surgery or the latest 20 weeks after registration
Pattern of recurrence
Pattern of recurrence is defined as location of first tumor recurrence. Patterns can be locoregional or distant or any combination of these patterns.
Patients with secondary malignancies or patients with no recurrence will not be taken into consideration for this endpoint.
Measured: after recurrence or latest 5 years after surgery
Treatment feasibility
The following feasibility criteria will be assessed:
- completion of 4 cycles of neoadjuvant chemotherapy
- completion of 4 cycles of neoadjuvant durvalumab treatment
- timely admission to and completion of planned surgery
- timely initiation and completion of 10 cycles of adjuvant durvalumab treatment
Measured: after treatment end or the latest 73 weeks after registration
Adverse events
All AEs will be assessed according to NCI CTCAE v4.03
Measured: within treatment start and 90 days after last trial treatment and resolution of all related AEs thereafter (at the latest 5 years after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start15 May 2018
- Primary completion25 Feb 2022
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Cathomas, MD, Study director, Kantonsspital Graubünden, Chur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406650
- Sponsor's protocol ID
- SAKK 06/17
- Other IDs
- 2017-003565-10, 2017
- Acronym
- SAKK 06/17
- Status last verified
- May 2025
- First submitted
- 22 Dec 2017
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer. A Multicenter, Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT03406650
- Acronym / sponsor ID
- SAKK 06/17 / SAKK 06/17
- Conditions
- Urothelial Cancer
- Keywords
- muscle invasive urothelial cancer, cancer, immunotherapy, durvalumab, MEDI4736, adjuvant, neoadjuvant, radical cystectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 23 Jan 2018 (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 main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab, to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival.
Detailed description
Despite optimal surgical management the prognosis for localized muscle invasive urothelial cancer (MIUC) is unfavorable with 5-year overall survival of around 45%.
According to international guidelines the use of cisplatin-based neoadjuvant chemotherapy is considered standard of care in all patients with localized MIUC with planned curative local treatment.
However, the benefit of neoadjuvant chemotherapy is limited and there is a clear medical need for improvement for this patient population.
Durvalumab has been tested in a phase I/II open-label study including patients with metastatic urothelial cancer (mUC).
The results demonstrated an overall response rate (RR) of 31% in 42 response-evaluable patients. The side effect profile was favorable with most common grade 1/2 AE representing fatigue (13%), diarrhea (10%) and decreased appetite (8%). Three patients (4.9%) had treatment related grade 3 AE's, no grade 4/5 events were noted.
The combination of cisplatin/gemcitabine chemotherapy with modern immune-checkpoint inhibition has been demonstrated to be feasible with demonstration of favorable immunomodulatory effects.
In view of these data it appears a logical step to apply these novel agents in the curative setting of neoadjuvant treatment.
The expected benefit of combining chemotherapy with durvalumab and to continue durvaluamb postoperatively might be twofold:
- to increase the response rate in the pre-operative setting and subsequently to increase the rate of pathologic complete remission (pT0) and to reduce risk of local recurrence
- to evoke durable systemic anti-cancer responses and subsequently to increase disease free- and overall survival and furthermore to induce antitumor immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab in combination with standard therapy | Experimental | Drug: Neoadjuvant and adjuvant durvalumabCombination of standard therapy consisting (4 cycles cisplatin/ gemcitabin followed by surgery) with 4 cycles of neoadjuvant durvalumab and 10 cycles of adjuvant durvalumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- Histologically proven urothelial cell carcinoma of the bladder, urethra or upper urinary tract (T2, T3, or T4a and ≤ N1 (defined as a solitary lymph node ≤ 2 cm in the greatest dimension), M0) and be considered suitable for curative multimodality treatment including surgery by a multidisciplinary tumor board. Cytological diagnosis is only allowed for upper tract urothelial carcinoma. In these cases tumor has to be documented by urography
- All histological subtypes eligible if urothelial carcinoma predominant (exception: small cell component)
- Age ≥ 18 years
- WHO performance status 0-1
Key exclusion criteria (23 listed)
- Any pathological evidence of small-cell carcinoma component
- Presence of any distant metastasis
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years before registration, with the exception of adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer or low risk localized prostate cancer (T1-T2a, Gleason <7, PSA <10ng/ml)
- Any previous treatment with a PD-1 or PD-L1 inhibitor, including durvalumab
- Concurrent treatment with prednisone (or equivalent); except for the prophylactic medication before chemotherapy, treatment of acute hypersensitivity reactions or chronic treatment (initiated > 6 months prior to registration) at low dose (≤ 10 mg/day of prednisone or an equivalent corticosteroid)
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 |
|---|---|---|
| Neoadjuvant and adjuvant durvalumabAlso: MEDI4736Neoadjuvant durvalumab 1500 mg q3w for 4 cycles Adjuvant durvalumab 1500 mg q4w for 10 cycles | Drug | Durvalumab in combination with standard therapy |
Primary outcome
event-free survival (EFS)
Time frame: 2 years after treatment start
The primary endpoint of the trial is Event-free survival (EFS) at 2 years after neoadjuvant trial treatment start. Event-free survival is defined as the time from treatment start until one of the following events, whichever comes first: * Progression during neoadjuvant treatment leading to inoperability * Recurrence of locoregional disease after surgery * Appearance of metastases at any localization * Death Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a subsequent treatment, if any.
9 secondary outcomes
Event-free survival (EFS)
Time frame: at the occurrence of the event or latest 5 years after surgery
Recurrence-free survival (RFS) after R0 resection
Time frame: at recurrence or latest 5 years after surgery
Overall survival (OS)
Time frame: at death or latest 5 years after surgery
Quality of resection
Time frame: after surgery or the latest 20 weeks after registration
Pathological complete response rate (ypT0)
Time frame: after surgery or the latest 20 weeks after registration
Pathological response rate (PaR) defined by pathological downstaging to ≤ypT1N0M0
Time frame: after surgery or the latest 20 weeks after registration
Pattern of recurrence
Time frame: after recurrence or latest 5 years after surgery
Treatment feasibility
Time frame: after treatment end or the latest 73 weeks after registration
Adverse events
Time frame: within treatment start and 90 days after last trial treatment and resolution of all related AEs thereafter (at the latest 5 years after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- 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.
Richard Cathomas, MD study director
Kantonsspital Graubünden, Chur
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant and adjuvant durvalumab in people with Urothelial Cancer, run by Swiss Cancer Institute at 17 sites in 2 countries.
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 12 inclusion and 23 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: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Switzerland, Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
event-free survival (EFS) (time frame: 2 years after treatment start). 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 4 May 2025.