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Alkylating agent

Cisplatin + Gemcitabine +/- Berzosertib for Bladder Cancer

Phase 2

Waitlist Available

Led By Sumanta K Pal

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed metastatic urothelial carcinoma; urothelial cancer derived from the bladder, ureter or upper tract is permitted

No prior cytotoxic chemotherapy for metastatic disease; prior immunotherapy is permitted

Must not have

Patients with >= grade 2 neuropathy

History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX970), cisplatin, or gemcitabine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing cisplatin + gemcitabine with or without berzosertib to see if it's effective in treating patients with urothelial cancer that has spread.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Cisplatin can cause kidney damage, hearing loss, nausea, vomiting; gemcitabine's side effects include flu-like symptoms, rash, low blood counts leading to infection risk; berzosertib's potential side effects aren't fully known but may include fatigue and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

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

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

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I am mostly independent and can carry out daily activities.

Exclusion Criteria

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

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I have moderate to severe nerve pain or damage.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Confirmed Objective Response Rate

Overall Survival (OS)

Treatment Limiting Adverse Events

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Berzosertib

2021

Completed Phase 2

~80

Cisplatin

2013

Completed Phase 3

~3120