Cisplatin + Gemcitabine +/- Berzosertib for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+42 other locations

Sumanta Kumar Pal, M.D., FASCO | City ...

Overseen BySumanta K. Pal

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without berzosertib works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with berzosertib in treating patients with urothelial cancer.

Eligibility Criteria

This trial is for adults with metastatic urothelial carcinoma, including cancers from the bladder, ureter, or upper tract. Participants must not have had chemotherapy for metastatic disease but may have had immunotherapy. They should be in good physical condition (Karnofsky >= 70%), have proper organ function, and no severe illnesses that could interfere with the study. Women of childbearing potential and men must use effective contraception during the study.

Inclusion Criteria

My cancer originates from the bladder, ureter, or upper tract and has spread.

I haven't had chemotherapy for my advanced cancer, but I may have had immunotherapy.

It has been over a year since I had platinum-based treatment around surgery time.

My kidney function, measured by creatinine clearance, is good.

I agree to use birth control during and up to 6 months after the study.

I have a tumor that can be measured with scans or exams.

I am mostly independent and can carry out daily activities.

Exclusion Criteria

I have moderate to severe nerve pain or damage.

I am allergic to M6620, cisplatin, or gemcitabine, or similar drugs.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Participant Groups

The trial is testing how well cisplatin and gemcitabine hydrochloride work alone compared to when combined with berzosertib in treating metastatic urothelial cancer. Cisplatin and gemcitabine are chemotherapy drugs; berzosertib blocks enzymes needed by cancer cells to grow.

2Treatment groups

Experimental Treatment

Group I: Arm B (gemcitabine hydrochloride, cisplatin)Experimental Treatment2 Interventions

Patients receive gemcitabine hydrochloride and cisplatin as in Arm A.

Group II: Arm A (berzosertib, gemcitabine hydrochloride, cisplatin)Experimental Treatment3 Interventions

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and cisplatin IV over 60 minutes on day 1. Patients also receive berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: