Daratumumab for Bladder and Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Matthew Campbell, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with muscle invasive bladder cancer or metastatic kidney cancer who are not pregnant, have an ECOG performance status of <=2, and meet specific health criteria like blood counts and organ function. They must not be on other trials, have certain infections (like HIV), or untreated brain metastases. Participants should agree to use contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Bladder Cancer Cohort)
Participants receive daratumumab by vein 1 time each week for 4 weeks before cystectomy
Surgery (Bladder Cancer Cohort)
Participants undergo cystectomy during weeks 6-8
Follow-up (Bladder Cancer Cohort)
Participants are monitored for safety and effectiveness after treatment
Treatment (Renal Cancer Cohort)
Participants receive daratumumab by vein 1 time each week for 8 weeks before nephrectomy, metastasectomy, or biopsy
Surgery/Biopsy (Renal Cancer Cohort)
Participants undergo nephrectomy, metastasectomy, or biopsy during weeks 10-12
Extended Treatment (Renal Cancer Cohort)
Participants may receive additional doses of daratumumab every 2 weeks for 4 months and then monthly for 1 year
Follow-up (Renal Cancer Cohort)
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Janssen Research & Development, LLC
Industry Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University