A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy



Status:Not yet recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:April 30, 2019
End Date:August 23, 2023

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A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (MORPHEUS-mUC)

A Phase Ib/II, open-label, multicenter, randomized, umbrella study 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).


Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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 agents
that block CD38

- 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

- 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

- 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
We found this trial at
4
sites
Louisville, Kentucky 40207
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Louisville, KY
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Caen,
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Los Angeles, California 90095
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Los Angeles, CA
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San Francisco, California 94115
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San Francisco, CA
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