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NCT03473730 · ClinicalTrials.gov registry record · Early Phase 1

Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer

A Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Early Phase 1
Development phase
17
Enrollment target
1
Study location

NCT03473730 is a Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 17 participants, below the 203-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03473730, a Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Early Phase 1
Development phase
17 participants
Enrollment target
1
Study location

Study Summary

Objectives: Primary: Safety and tolerability of therapy with daratumumab in a cohort of patients with metastatic renal cell carcinoma and a cohort of patients with muscle invasive bladder cancer. Secondary: 1A. To assess the proportion of patients who achieve pathological CR with daratumumab in patients with muscle invasive bladder cancer. 1B. To assess the objective response rate (ORR) to daratumumab in patients with metastatic renal cell carcinoma. 2\. To assess the progression free survival for patients with metastatic renal cell carcinoma receiving Daratumumab.

Conditions Studied

Clear Cell Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8 Bladder Urothelial Carcinoma Metastatic Kidney Carcinoma Malignant Urinary System Neoplasm

Interventions

  • PROCEDURE Biopsy
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Daratumumab
  • PROCEDURE Metastasectomy
  • PROCEDURE Nephrectomy

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2018-05-29
Est. Completion 2025-01-27
Phase Early Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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What the Registry Record Tells You About NCT03473730

The ClinicalTrials.gov registry entry for NCT03473730 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 203-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (92% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biopsy is the first listed.

NCT03473730 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03473730 about?

NCT03473730 is a clinical study titled "Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer". Objectives: Primary: Safety and tolerability of therapy with daratumumab in a cohort of patients with metastatic renal cell carcinoma and a cohort of patients with muscle invasive bladder cancer. Secondary: 1A. To assess the proportion of patients who achieve pathological CR with daratumumab in ...

What is the current status of trial NCT03473730?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2018-05-29. Estimated completion is 2025-01-27.

What conditions does trial NCT03473730 study?

This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Bladder Urothelial Carcinoma, Metastatic Kidney Carcinoma, Malignant Urinary System Neoplasm.

What interventions are being tested in trial NCT03473730?

The interventions under investigation include: Biopsy (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Daratumumab (BIOLOGICAL), Metastasectomy (PROCEDURE), Nephrectomy (PROCEDURE).

Who is sponsoring clinical trial NCT03473730?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03473730 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.