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Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

NCT04887831 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-09-08

Study results available
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Summary

This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in participants receiving first-line treatment for advanced/metastatic urothelial carcinoma.

Conditions

Interventions

DRUG

Trilaciclib

Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered.

DRUG

Gemcitabine

Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle

DRUG

Cisplatin

Cisplatin administered IV on Day 1 of each 21-day cycle

DRUG

Carboplatin

Carboplatin administered IV on Day 1 of each 21-day cycle

DRUG

Avelumab

Avelumab administered IV on Day 1 of each 14-day maintenance cycle

Sponsors & Collaborators

  • G1 Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical study director · G1 Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-04
Primary Completion
2023-04-07
Completion
2024-03-01
FDA Drug
Yes

Countries

  • United States
  • France
  • Georgia
  • Hungary
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887831 on ClinicalTrials.gov