Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Recruiting Phase 2 Phase 3 Interventional Study
Muscle Invasive Bladder Urothelial Carcinoma Muscle Invasive Renal Pelvis Urothelial Carcinoma Muscle Invasive Ureter Urothelial Carcinoma Muscle Invasive Urethral Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage IV Bladder Urothelial Carcinoma AJCC v7
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
992 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for adults who have had surgery to remove their bladder, kidney, ureter, or urethra because of a specific type of urinary tract cancer. They must not have any visible cancer left after surgery and should not have had certain treatments beforehand. If someone has had major heart issues or significant problems that make common chemotherapy unsafe, they would not be able to participate.

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About This Trial
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA w…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis * PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblas…
Contacts

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