Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Cabozantinib S-malate for Bladder Adenocarcinoma

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Official registry: https://clinicaltrials.gov/study/NCT03866382 · National Cancer Institute (NCI) · enrollment listed as 314

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Bone Scan, or Cabozantinib S-malate. The registry lists allocation as na. This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body.

They plan to enroll about 314 people at 582 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Interventions: Biospecimen Collection, Bone Scan, Cabozantinib S-malate, Computed Tomography, Echocardiography Test, Ipilimumab, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography

Primary outcome (registry wording): Objective response rate (ORR)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:
  • One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
  • One bone lesion on bone scan (tec99 or sodium fluoride \[NaF\] PET/CT, CT or MRI) for the bone-only cohort
  • Histologically confirmed diagnosis of one of the following metastatic cohorts:
  • Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization \[WHO\] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma
  • Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)
  • Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly \> or equal \~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well)

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

582 listed

+ 1 sites outside the US on the same record

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NCT00026884 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT03866382 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03866382?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03866382?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary