Daratumumab for Bladder and Kidney Cancer

Recruiting in Palo Alto (17 mi)

Matthew T Campbell | MD Anderson Cancer ...

Overseen byMatthew Campbell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

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.

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.

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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

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Treatment Details

Interventions

Daratumumab (Monoclonal Antibodies)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Cohort 2 Bladder (daratumumab)Experimental Treatment2 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 Treatment5 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