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Monoclonal Antibodies

Daratumumab for Bladder and Kidney Cancer

Phase < 1

Waitlist Available

Led By Matthew T Campbell

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BLADDER: ANC >= 1500/mm^3 without colony stimulating factor support (clinical laboratory values at screening)

RENAL & BLADDER: Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of =< 2

Must not have

RENAL & BLADDER: Currently enrolled in another interventional study

RENAL COHORT: Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of study treatment up to 6 weeks post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of daratumumab in patients with metastatic renal cell carcinoma or muscle invasive bladder cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Daratumumab may cause immune system reactions such as infusion-related reactions; it could also affect blood cell counts leading to increased risk of infections or bleeding. Organ-specific inflammation is possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My white blood cell count is healthy without needing medication.

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I can take care of myself but might not be able to do heavy physical work.

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I cannot receive cisplatin for my bladder cancer due to kidney, heart, nerve issues, or hearing loss.

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My kidney function is good enough for the trial, and I am not on dialysis.

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My hemoglobin level is 9 g/dL or higher.

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My blood protein level is at least 2.8g/dl.

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My kidney function is good enough for the trial, not on dialysis.

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My kidney cancer has a clear cell component.

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I have a kidney tumor that can be measured and is not where my surgery will be.

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My liver enzymes, ALT and AST, are within normal limits.

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My bladder cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not participating in another drug study.

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I have treated and stable brain metastases from kidney cancer and don't need steroids.

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I do not have an active infection like HIV, hepatitis, or a fungal infection needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 weeks after completion of study treatment (bladder cohort) or 6 weeks post-surgery (renal cohort)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 weeks after completion of study treatment (bladder cohort) or 6 weeks post-surgery (renal cohort)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 weeks after completion of study treatment (bladder cohort) or 6 weeks post-surgery (renal cohort) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Rate of surgical delay (Bladder cohort)

Secondary study objectives

Best objective response rate (ORR) (Renal cohort)

Pathologic response (Bladder cohort)

Progression-free survival (PFS) (Renal cohort)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nephrectomy

2013

Completed Phase 3

~1430

Biopsy

2014

Completed Phase 4

~1090