Daratumumab for Bladder and Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: Tyrosine kinase inhibitors, PD-1/PD-L1 inhibitors

Must not be taking: Corticosteroids, Antivirals

Disqualifiers: Active infection, Cardiovascular disease, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

17 Participants Needed

Trial Summary

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.

Research Team

Matthew Campbell, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Your hemoglobin level needs to be at least 9 g/dL within 4 days before starting the daratumumab treatment.

Your blood albumin level is at least 2.8 g/dl within 4 days before taking the first dose of daratumumab.

My white blood cell count is healthy without needing medication.

Exclusion Criteria

I am not participating in another drug study.

I have been tested for hepatitis B and C, and understand my infection status.

RENAL COHORT: The subject has received any other type of investigational agent within 28 days before the first dose of study treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Bladder Cancer Cohort)

Participants receive daratumumab by vein 1 time each week for 4 weeks before cystectomy

4 weeks

4 visits (in-person)

Surgery (Bladder Cancer Cohort)

Participants undergo cystectomy during weeks 6-8

2 weeks

1 visit (in-person)

Follow-up (Bladder Cancer Cohort)

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment (Renal Cancer Cohort)

Participants receive daratumumab by vein 1 time each week for 8 weeks before nephrectomy, metastasectomy, or biopsy

8 weeks

8 visits (in-person)

Surgery/Biopsy (Renal Cancer Cohort)

Participants undergo nephrectomy, metastasectomy, or biopsy during weeks 10-12

2 weeks

1 visit (in-person)

Extended Treatment (Renal Cancer Cohort)

Participants may receive additional doses of daratumumab every 2 weeks for 4 months and then monthly for 1 year

12 months

Bi-weekly visits for 4 months, then monthly visits

Follow-up (Renal Cancer Cohort)

Participants are monitored for safety and effectiveness after treatment

13 weeks

1 visit (in-person)

Treatment Details

Interventions

• Daratumumab

Trial Overview The trial tests daratumumab's safety and effectiveness in treating these cancers. It includes a nephrectomy (kidney removal) for kidney cancer patients, biopsies to examine tissue samples, laboratory biomarker analysis to monitor responses, and possibly a metastasectomy if there are isolated areas of spread that can be surgically removed.

Participant Groups

Group I: Cohort 2 Bladder (daratumumab) Experimental Treatment 2 Interventions

Patients receive daratumumab IV over 8 hours for the first dose and then over 4 hours for all doses thereafter beginning at week 1. Cycles repeat every week for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Cohort 1 Renal (daratumumab, biopsy, surgery) Experimental Treatment 5 Interventions

Patients receive daratumumab IV over 8 hours for the first dose and then over 4 hours for all doses thereafter during weeks 1-8. Treatment repeats every week for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo biopsy, nephrectomy, or metastasectomy during weeks 10-12. Patients may then restart treatment with daratumumab beginning 2 weeks after biopsy or 4-6 weeks after nephrectomy or metastasectomy. Cycles repeat every 2 weeks for 4 months and then monthly for 1 year in the absence of disease progression or unacceptable toxicity.

Daratumumab is already approved in European Union, United States for the following indications:

Approved in European Union as Darzalex for:

• Relapsed and refractory multiple myeloma
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

Approved in United States as Darzalex for:

• Multiple myeloma in patients who have received at least three prior therapies
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
• Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Janssen Research & Development, LLC

Industry Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires