Urothelial CarcinomaPhase 1/2NCT03869190
Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
A Phase 1/2 study testing Atezolizumab, Enfortumab Vedotin and Niraparib in people with Urothelial Carcinoma and Bladder Cancer, run by Hoffmann-La Roche at 33 sites in 7 countries.
Trial summary
A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Bladder Cancer
- What is being tested?
- Atezolizumab, Enfortumab Vedotin and Niraparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 1 Jun 2019to 22 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically documented, locally advanced or metastatic UC (also termed TCC or urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
- Disease progression during or following treatment with no more than one platinum-containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
- ECOG Performance Status of 0 or 1
- Measurable disease (at least one target lesion) according to RECIST v1.1
- Adequate hematologic and end-organ function
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- Negative HIV test at screening
- Negative total hepatitis B core antibody (HBcAb) test and hepatitis C virus (HCV) antibody at screening
- Tumor accessible for biopsy
- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
- ECOG PS of 0 or 1
- Fit and planned-for cystectomy
- Histologically documented MIBC (pT2-4, N0, M0), also termed TCC or urothelial cell carcinoma of the urinary bladder
- N0 or M0 disease by CT or MRI
- Adequate hematologic and end-organ function
- Availability of TURBT specimen
- Negative HIV, HBcAb, and HCV test at screening
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Who cannot join
- Prior treatment with a T-cell co-stimulating therapy or a CPI including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Prior treatment with any of the protocol-specified study treatments including treatment with poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, nectin-4 targeting agents, signal regulatory protein alpha-targeting agents, or TIGIT-targeting agents, Trop-2 targeting agents, FAP-directed therapies, 4-1BB (CD137)-directed therapies, or topoisomerase 1 inhibitors
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
- Eligibility only for the control arm
- Prior allogeneic stem cell or solid organ transplantation
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- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the initiation of study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia
- Symptomatic, untreated, or actively progressing CNS metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- History of malignancy other than UC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- Significant cardiovascular disease
- Uncontrolled hypertension
- Grade 3 or greater hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Additional drug-specific exclusion criteria might apply
- Prior treatment with systemic immunostimulatory agents prior to the initiation of study treatment
- Eligibility only for the control arm
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment, with the following exceptions: Patients who received acute, low-dose, systemic immunosuppressant medications, or a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after Medical Monitor approval has been obtained. Patients who received mineralocorticoids, corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
- Severe infection within 4 weeks prior to initiation of study treatment
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Also includes all the mUC exclusion criteria
- Additional Exclusion Criteria for Atezo+Tira and Atezo (Atezolizumab) +Tira+Cis (Cisplatin)+Gem (Gemcitabine) in the MIBC Cohorts:
- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening.
- Additional Exclusion Criteria for the Cisplatin-Eligible MIBC Cohort:
- Patients who decline neoadjuvant cisplatin-based chemotherapy or in whom neoadjuvant cisplatin-based therapy is not appropriate.
- Impaired renal function.
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
Spain12 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Institut Catala d Oncologia Hospitalet
Barcelona, 08908
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital General Universitario Gregorio Mara
Madrid, 28009
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040
Hospital Univ 12 de Octubre
Madrid, 28041
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, 28050
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, 15706
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States10 sites
Levine Cancer Institute
Charlotte, North Carolina, 28204
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
Cleveland Clinic
Cleveland, Ohio, 44195
Memorial Sloan-Kettering Cancer Center
Commack, New York, 11725
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
UCLA Department of Medicine
Los Angeles, California, 90024
Norton Cancer Institute
Louisville, Kentucky, 40241
UCSF Comprehensive Cancer Ctr
San Francisco, California, 94115
Stanford Cancer Center
Stanford, California, 94305-5820
France4 sites
Centre Francois Baclesse
Caen, 14076
Centre Leon Berard
Lyon, 69008
Institut régional du Cancer Montpellier
Montpellier, 34298
Institut Claudius Regaud
Toulouse, 31052
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Severance Hospital
Seoul, 120-749
Greece2 sites
Attiko Hospital University of Athens
Athens, 12462
Athens Medical Center
Athens, 151 25
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
United Kingdom1 site
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
Official title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Being tested
- Atezolizumab, Enfortumab Vedotin, Niraparib, Magrolimab (Hu5F9-G4), Tiragolumab
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
For the control, + EV, + Nira, + Tira, and + SG arms, + RO7122290, Atezolizumab will be administered intravenously (IV) at a fixed dose of 1200 mg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
For the Atezo + Hu5F9-G4 and + TCZ arms, Atezo will be administered IV at a fixed dose of 840 mg every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle.
Enfortumab VedotinDrug
Enfortumab vedotin will be administered at a dose of 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle.
NiraparibDrug
Niraparib will be administered at a dose of 200 mg once daily (QD) by mouth.
Magrolimab (Hu5F9-G4)Drug
Participants will receive an 1-mg/kg priming dose IV on Day 1 followed by three weekly IV doses of 30 mg/kg on Days 8, 15, and 22. During Cycle 2, participants will receive weekly IV doses of 30 mg/kg on Days 1, 8, 15, and 22. For all subsequent cycles, participants will receive 30 mg/kg on Days 1 and 15. Cycle = 28 days.
TiragolumabDrug
Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21-day cycle.
Sacituzumab GovitecanDrug
Sacituzumab Govitecan will be administered at a dose of 10 mg/kg by IV on Day 1 and 8 of each 21-day cycle.
TocilizumabDrug
Tocilizumab will be administered by IV infusion at a dose of 8 mg/kg every 4 weeks (Q4W) on Day 1 of each 28-day cycle.
CisplatinDrug
Cisplatin will be administered at a dose of 70mg/m^2 by IV on Day 1 of each cycle for Cycles 1-3 pre-surgery.
GemcitabineDrug
Gemcitabine will be administered at a dose of 1000mg/m^2 by IV on Days 1 and 8 of each cycle for Cycles 1-3 pre-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab for mUC Cohort (Stage 1) | Active comparator | Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Enrollment is closed. Receives: Drug: Atezolizumab |
| Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Enfortumab Vedotin |
| Atezolizumab + Niraparib for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and Niraparib (Nira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Niraparib |
| Atezolizumab + Magrolimab for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and magrolimab (Hu5F9-G4) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Magrolimab (Hu5F9-G4) |
| Atezolizumab + Tiragolumab for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and Tiragolumab (Tira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Sacituzumab Govitecan |
| Atezolizumab + Tocilizumab for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and Tocilizumab (TCZ) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Tocilizumab |
| Atezolizumab + RO7122290 for mUC Cohort (Stage 1) | Experimental | Participants will receive atezolizumab and RO7122290 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab |
| Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2) | Experimental | Participants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Enfortumab Vedotin |
| Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2) | Experimental | Participants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. Receives: Drug: Atezolizumab; Drug: Sacituzumab Govitecan |
| Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1 | Active comparator | Participants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery. Receives: Drug: Atezolizumab |
| Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2 | Experimental | Participants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1 | Active comparator | Participants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery. Receives: Drug: Atezolizumab |
| Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2 | Experimental | Participants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Cisplatin-eligible MIBC Cohort 3 Arm 1 | Active comparator | Participants will receive 3 cycles of Atezolizumab, Cisplatin, and Gemcitabine pre-surgery and 14 cycles of Atezolizumab only post-surgery. Receives: Drug: Atezolizumab; Drug: Cisplatin; Drug: Gemcitabine |
| Cisplatin-eligible MIBC Cohort 3 Arm 2 | Experimental | Participants will receive Atezolizumab, Tiragolumab (Tira), Cisplatin and Gemcitabine for 3 cycles pre-surgery and 14 cycles of Atezolizumab and Tiragolumab (Tira) post-surgery. Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 mUC Cohorts: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Measured: Up to 61.5 months
MIBC Cohorts: Pathological Complete Response (pCR)
pCR was defined as the percentage of participants with an absence of residual invasive cancer of the complete resected specimen. Percentages have been rounded off.
Measured: Up to 17.8 months
Secondary outcomes (12)
Stage 1 mUC Cohorts: Progression-free Survival (PFS) After Randomization
PFS after randomization was defined as the time from randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurred first in Stage 1, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. PFS for participants with no documented PD or death was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate the median PFS.
Measured: From randomization to PD or death from any cause, whichever occurred first (up to 62 months)
Stage 1 mUC Cohorts: Overall Survival (OS) After Randomization
OS after randomization was defined as the time from randomization to death from any cause. Data for participants who had not died were censored at the last date they were known to be alive. K-M method was used to estimate the median OS.
Measured: From randomization to death from any cause (up to 69.1 months)
Stage 1 mUC Cohorts: OS Rate at Month 12
OS rate at Month 12 was defined as percentage of participants who did not experience death from any cause at the specified timepoint. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off.
Measured: At Month 12
Stage 1 mUC Cohorts: Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented OR (CR or PR) during Stage 1 to PD or death from any cause during Stage 1, whichever occurred first, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median DOR.
Measured: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to 61.5 months)
Stage 1 mUC Cohorts: Disease Control Rate (DCR)
DCR was defined as percentage of participants with stable disease for ≥ 18 weeks or an OR (CR or PR) during Stage 1, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage of target lesions to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.
Measured: Up to 61.5 months
Stages 1 and 2 mUC Cohorts: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Stage 1: Up to 62.1 months; Stage 2: Up to 18.3 months
Stage 2 mUC [Atezo + EV Cohort]: Serum Concentration of Atezolizumab at Specified Timepoints
Measured: Predose: Day 1 of Cycles 1, 2 and 4; 30 minutes postdose: Day 1 Cycle 1
Stage 2 mUC [Atezo + EV Cohort]: Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Measured: Up to approximately 18.3 months
MIBC Cohorts: Landmark Recurrence-free Survival (RFS) Rate
Landmark RFS was defined as the percentage of participants who were alive without disease recurrence at specified timepoints following surgery. RFS was defined as the time from Day 1 in the first cycle after surgery to the first documented recurrence of disease or death from any cause. RFS rates at the specified landmark timepoints were estimated using the K-M method.
Measured: At Months 12, 18, and 24
MIBC Cohorts: Landmark Event-free Survival (EFS) Rate
Landmark EFS was defined as the percentage of participants who were alive without experiencing a predefined event at specified timepoints. EFS was defined as the time from randomization to any of the following events, whichever occurred first: PD that precludes surgery, as assessed by the investigator; local or distant disease recurrence; or death from any cause. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. EFS rates at the specified landmark timepoints were estimated using the K-M method.
Measured: At Months 12, 18, and 24
MIBC Cohorts: Landmark OS Rate
Landmark OS was defined as the percentage of participants who were alive at specified timepoints. OS was defined as the time from randomization to death from any cause. OS rates at the specified landmark timepoints were estimated using the K-M method.
Measured: At Months 12, 18, and 24
MIBC Cohorts: Number of Participants With AEs
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 17.8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Jun 2019
- Primary completion8 Oct 2025
- Study completion22 Dec 2025
Why it stopped: Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869190
- Sponsor's protocol ID
- WO39613
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2019
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Drakaki A, Powles T, Bamias A, Martin-Liberal J, Shin SJ, Friedlander T, Tosi D, Park C, Gomez-Roca C, Joly Lobbedez F, Castellano D, Morales-Barrera R, Moreno-Candilejo I, Flechon A, Yuen K, Rishipathak D, DuPree K, Young F, Michielin F, Shemesh CS, Steinberg EE, Williams P, Lee JL. Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma). Clin Cancer Res. 2023 Nov 1;29(21):4373-4384. doi: 10.1158/1078-0432.CCR-23-0798.
PubMed 37651261
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)
- ClinicalTrials.gov ID
- NCT03869190
- Acronym / sponsor ID
- WO39613
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab for mUC Cohort (Stage 1) | Active comparator | Drug: AtezolizumabParticipants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1) | Experimental | Drug: Atezolizumab, Drug: Enfortumab VedotinParticipants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Niraparib for mUC Cohort (Stage 1) | Experimental | Drug: Atezolizumab, Drug: NiraparibParticipants will receive atezolizumab and Niraparib (Nira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Magrolimab for mUC Cohort (Stage 1) | Experimental | Drug: Atezolizumab, Drug: Magrolimab (Hu5F9-G4)Participants will receive atezolizumab and magrolimab (Hu5F9-G4) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Tiragolumab for mUC Cohort (Stage 1) | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants will receive atezolizumab and Tiragolumab (Tira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1) | Experimental | Drug: Atezolizumab, Drug: Sacituzumab GovitecanParticipants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Tocilizumab for mUC Cohort (Stage 1) | Experimental | Drug: Atezolizumab, Drug: TocilizumabParticipants will receive atezolizumab and Tocilizumab (TCZ) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + RO7122290 for mUC Cohort (Stage 1) | Experimental | Drug: AtezolizumabParticipants will receive atezolizumab and RO7122290 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2) | Experimental | Drug: Atezolizumab, Drug: Enfortumab VedotinParticipants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2) | Experimental | Drug: Atezolizumab, Drug: Sacituzumab GovitecanParticipants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1 | Active comparator | Drug: AtezolizumabParticipants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2 | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1 | Active comparator | Drug: AtezolizumabParticipants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2 | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Cisplatin-eligible MIBC Cohort 3 Arm 1 | Active comparator | Drug: Atezolizumab, Drug: Cisplatin, Drug: GemcitabineParticipants will receive 3 cycles of Atezolizumab, Cisplatin, and Gemcitabine pre-surgery and 14 cycles of Atezolizumab only post-surgery. |
| Cisplatin-eligible MIBC Cohort 3 Arm 2 | Experimental | Drug: Atezolizumab, Drug: Tiragolumab, Drug: Cisplatin, Drug: GemcitabineParticipants will receive Atezolizumab, Tiragolumab (Tira), Cisplatin and Gemcitabine for 3 cycles pre-surgery and 14 cycles of Atezolizumab and Tiragolumab (Tira) post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically documented, locally advanced or metastatic UC (also termed TCC or urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing
- Disease progression during or following treatment with no more than one platinum-containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
- ECOG Performance Status of 0 or 1
- Measurable disease (at least one target lesion) according to RECIST v1.1
Key exclusion criteria (38 listed)
- Prior treatment with a T-cell co-stimulating therapy or a CPI including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Prior treatment with any of the protocol-specified study treatments including treatment with poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, nectin-4 targeting agents, signal regulatory protein alpha-targeting agents, or TIGIT-targeting agents, Trop-2 targeting agents, FAP-directed therapies, 4-1BB (CD137)-directed therapies, or topoisomerase 1 inhibitors
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
- Eligibility only for the control arm
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 |
|---|---|---|
| AtezolizumabFor the control, + EV, + Nira, + Tira, and + SG arms, + RO7122290, Atezolizumab will be administered intravenously (IV) at a fixed dose of 1200 mg every 3 weeks (Q3W) on Day 1 of each 21-day cycle. For the Atezo + Hu5F9-G4 and + TCZ arms, Atezo will be administered IV at a fixed dose of 840 mg every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle. | Drug | Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1), Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2), Atezolizumab + Magrolimab for mUC Cohort (Stage 1), Atezolizumab + Niraparib for mUC Cohort (Stage 1), Atezolizumab + RO7122290 for mUC Cohort (Stage 1), Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1), Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2), Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2, Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2, Atezolizumab + Tiragolumab for mUC Cohort (Stage 1), Atezolizumab + Tocilizumab for mUC Cohort (Stage 1), Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1, Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1, Atezolizumab for mUC Cohort (Stage 1), Cisplatin-eligible MIBC Cohort 3 Arm 1, Cisplatin-eligible MIBC Cohort 3 Arm 2 |
| Enfortumab VedotinEnfortumab vedotin will be administered at a dose of 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle. | Drug | Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1), Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2) |
| NiraparibNiraparib will be administered at a dose of 200 mg once daily (QD) by mouth. | Drug | Atezolizumab + Niraparib for mUC Cohort (Stage 1) |
| Magrolimab (Hu5F9-G4)Participants will receive an 1-mg/kg priming dose IV on Day 1 followed by three weekly IV doses of 30 mg/kg on Days 8, 15, and 22. During Cycle 2, participants will receive weekly IV doses of 30 mg/kg on Days 1, 8, 15, and 22. For all subsequent cycles, participants will receive 30 mg/kg on Days 1 and 15. Cycle = 28 days. | Drug | Atezolizumab + Magrolimab for mUC Cohort (Stage 1) |
| TiragolumabTiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21-day cycle. | Drug | Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2, Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2, Atezolizumab + Tiragolumab for mUC Cohort (Stage 1), Cisplatin-eligible MIBC Cohort 3 Arm 2 |
| Sacituzumab GovitecanSacituzumab Govitecan will be administered at a dose of 10 mg/kg by IV on Day 1 and 8 of each 21-day cycle. | Drug | Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1), Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2) |
| TocilizumabTocilizumab will be administered by IV infusion at a dose of 8 mg/kg every 4 weeks (Q4W) on Day 1 of each 28-day cycle. | Drug | Atezolizumab + Tocilizumab for mUC Cohort (Stage 1) |
| CisplatinCisplatin will be administered at a dose of 70mg/m^2 by IV on Day 1 of each cycle for Cycles 1-3 pre-surgery. | Drug | Cisplatin-eligible MIBC Cohort 3 Arm 1, Cisplatin-eligible MIBC Cohort 3 Arm 2 |
| GemcitabineGemcitabine will be administered at a dose of 1000mg/m^2 by IV on Days 1 and 8 of each cycle for Cycles 1-3 pre-surgery. | Drug | Cisplatin-eligible MIBC Cohort 3 Arm 1, Cisplatin-eligible MIBC Cohort 3 Arm 2 |
Primary outcome
Stage 1 mUC Cohorts: Objective Response Rate (ORR)
Time frame: Up to 61.5 months
ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart during Stage 1, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
MIBC Cohorts: Pathological Complete Response (pCR)
Time frame: Up to 17.8 months
pCR was defined as the percentage of participants with an absence of residual invasive cancer of the complete resected specimen. Percentages have been rounded off.
12 secondary outcomes
Stage 1 mUC Cohorts: Progression-free Survival (PFS) After Randomization
Time frame: From randomization to PD or death from any cause, whichever occurred first (up to 62 months)
Stage 1 mUC Cohorts: Overall Survival (OS) After Randomization
Time frame: From randomization to death from any cause (up to 69.1 months)
Stage 1 mUC Cohorts: OS Rate at Month 12
Time frame: At Month 12
Stage 1 mUC Cohorts: Duration of Response (DOR)
Time frame: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to 61.5 months)
Stage 1 mUC Cohorts: Disease Control Rate (DCR)
Time frame: Up to 61.5 months
Stages 1 and 2 mUC Cohorts: Number of Participants With Adverse Events (AEs)
Time frame: Stage 1: Up to 62.1 months; Stage 2: Up to 18.3 months
Stage 2 mUC [Atezo + EV Cohort]: Serum Concentration of Atezolizumab at Specified Timepoints
Time frame: Predose: Day 1 of Cycles 1, 2 and 4; 30 minutes postdose: Day 1 Cycle 1
Stage 2 mUC [Atezo + EV Cohort]: Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Time frame: Up to approximately 18.3 months
MIBC Cohorts: Landmark Recurrence-free Survival (RFS) Rate
Time frame: At Months 12, 18, and 24
MIBC Cohorts: Landmark Event-free Survival (EFS) Rate
Time frame: At Months 12, 18, and 24
MIBC Cohorts: Landmark OS Rate
Time frame: At Months 12, 18, and 24
MIBC Cohorts: Number of Participants With AEs
Time frame: Up to 17.8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37651261Drakaki A, Powles T, Bamias A, Martin-Liberal J, Shin SJ, Friedlander T, Tosi D, Park C, Gomez-Roca C, Joly Lobbedez F, Castellano D, Morales-Barrera R, Moreno-Candilejo I, Flechon A, Yuen K, Rishipathak D, DuPree K, Young F, Michielin F, Shemesh CS, Steinberg EE, Williams P, Lee JL. Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma). Clin Cancer Res. 2023 Nov 1;29(21):4373-4384. doi: 10.1158/1078-0432.CCR-23-0798.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab, Enfortumab Vedotin and Niraparib in people with Urothelial Carcinoma and Bladder Cancer, run by Hoffmann-La Roche at 33 sites in 7 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 20 inclusion and 38 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: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, United States, France, South Korea, Greece and 2 more countries. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stage 1 mUC Cohorts: Objective Response Rate (ORR) (time frame: Up to 61.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869190, which also lists 1 linked publication.
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 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.