Trilaciclib + Chemotherapy for Bladder Cancer

(PRESERVE3 Trial)

Recruiting in Palo Alto (17 mi)

+54 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: G1 Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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 patients receiving first-line treatment for advanced/metastatic bladder cancer.

Research Team

Clinical Contact

Principal Investigator

G1 Therapeutics, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I can provide samples of my tumor, either previously stored or newly taken.

I am 18 years old or older.

You have a disease that can be measured using a specific set of guidelines called RECIST v1.1.

Exclusion Criteria

Pregnant or lactating women

I have severe allergies to certain medications or uncontrolled asthma.

I have had a stem cell, bone marrow, or organ transplant.

Treatment Details

Interventions

• Avelumab (Immune Checkpoint Inhibitor)
• Carboplatin (Platinum-based Chemotherapy)
• Cisplatin (Platinum-based Chemotherapy)
• Gemcitabine (Antimetabolite)
• Trilaciclib (CDK 4/6 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Trilaciclib plus platinum-based chemotherapy followed by avelumab maintenance therapy Experimental Treatment 5 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 therapy Active Control 4 Interventions

Gemcitabine (1000 mg/m2) + Cisplatin (70 mg/m2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg)

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

G1 Therapeutics, Inc.

Lead Sponsor

Trials

22

Recruited

3,300+