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Platinum-based Chemotherapy

Trilaciclib + Chemotherapy for Bladder Cancer (PRESERVE3 Trial)

Phase 2
Waitlist Available
Research Sponsored by G1 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
No prior systemic therapy in the inoperable, locally advanced, or metastatic setting including chemotherapy, immune checkpoint inhibitor therapy, targeted therapy, or investigational agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until date of documented radiologic disease progression per recist v1.1 or death due to any cause, whichever comes first (on average 7 months)
Awards & highlights

PRESERVE3 Trial Summary

This trial is testing a new drug called trilaciclib to see if it's safe and effective when used with other drugs to treat bladder cancer.

Who is the study for?
Adults with advanced/metastatic bladder cancer who haven't had systemic therapy for their inoperable condition can join. They need available tumor tissue, a decent performance status (ECOG 0-2), and normal organ function. Exclusions include recent other cancers, certain past treatments like immune therapies or stem cell transplants, CNS metastases needing immediate treatment, severe allergies to trial drugs, pregnancy, active autoimmune diseases or current immunosuppressive meds.Check my eligibility
What is being tested?
The study is testing Trilaciclib with platinum-based chemo followed by Avelumab maintenance versus just the chemo then Avelumab in first-line treatment of bladder cancer. It's an open-label Phase 2 trial where patients are randomly assigned to either group to compare safety and effectiveness.See study design
What are the potential side effects?
Possible side effects may include reactions at the infusion site, fatigue, lowered blood counts leading to increased infection risk or bleeding problems (neutropenia/myelosuppression), liver issues indicated by abnormal lab values and potential allergic reactions.

PRESERVE3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I haven't had any drug treatments for my cancer since it became advanced.
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I can take care of myself and am up and about more than half of the day.
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My bladder cancer is advanced or has spread to other parts.

PRESERVE3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until date of documented radiologic disease progression per recist v1.1 or death due to any cause, whichever comes first (on average 7 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until date of documented radiologic disease progression per recist v1.1 or death due to any cause, whichever comes first (on average 7 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival
Secondary outcome measures
Anti-tumor Effects
Myeloprotective Effects

PRESERVE3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trilaciclib plus platinum-based chemotherapy followed by avelumab maintenance therapyExperimental Treatment5 Interventions
Trilaciclib (240 mg/m2) + Gemcitabine (1000 mg/m2) + Cisplatin (70 mg/m2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m2) + Avelumab (800 mg)
Group II: Platinum-based chemotherapy followed by avelumab maintenance therapyActive Control4 Interventions
Gemcitabine (1000 mg/m2) + Cisplatin (70 mg/m2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trilaciclib
2015
Completed Phase 4
~280
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,199 Total Patients Enrolled
Clinical ContactStudy DirectorG1 Therapeutics, Inc.
10 Previous Clinical Trials
1,223 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04887831 — Phase 2
Bladder Cancer Research Study Groups: Platinum-based chemotherapy followed by avelumab maintenance therapy, Trilaciclib plus platinum-based chemotherapy followed by avelumab maintenance therapy
Bladder Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04887831 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887831 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions in this clinical trial for new patients?

"This particular study, which was first made public on June 4th 2021, is not actively recruiting patients for participation. However, there are 4454 other clinical trials that are currently looking for candidates."

Answered by AI

Could you please share other instances where Cisplatin has been used in medical research?

"City of Hope Comprehensive Cancer Center was the first to study cisplatin in 1997 and, since then, 2279 clinical trials have completed. As of now, there are 1541 ongoing studies--a majority taking place in Whittier, Florida."

Answered by AI

Is this trial being done in more than one state?

"Currently, this study has 27 patients. The Oncology Institute of Hope and Innovation in Whittier, Florida Cancer Specialists - South in Fort Myers, Valkyrie Clinical Trial in Los Angeles are a few of the 27 locations where people are being recruited for this trial."

Answered by AI

What are some of the possible side effects that come with Cisplatin use?

"Cisplatin has received a safety score of 2. Although there is some clinical data suggesting it is safe, none of the trials thus far have shown that it is an effective treatment."

Answered by AI

For what purposes is Cisplatin typically employed?

"Cisplatin is often used to treat patients who have undergone adjuvant anthracycline-based therapy. This medication can also be effective in managing advanced endometrial cancer, melanoma, and lymphoma, non-hodgkin."

Answered by AI

How many people are allowed to take part in this experiment?

"Presently, this study is not enrolling patients. This research was initially posted on June 4th, 2021 and was last edited on October 25th, 2022. There are presently 2913 clinical trials actively looking for patients with neutropenia and 1541 studies for Cisplatin admitting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
2021. "Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04887831.
~24 spots leftby Apr 2025
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