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

NCT03473730 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-01-30

No results posted yet for this 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

  • Bladder Urothelial Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Malignant Urinary System Neoplasm
  • Metastatic Kidney Carcinoma
  • Stage IV Renal Cell Cancer AJCC V8

Interventions

PROCEDURE

Biopsy

Undergo biopsy

BIOLOGICAL

Daratumumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Metastasectomy

Undergo metastasectomy

PROCEDURE

Nephrectomy

Undergo nephrectomy

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Matthew T Campbell · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2025-01-27
Completion
2025-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473730 on ClinicalTrials.gov