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BRIEF TITLE: Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)

A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)


  • Org Study ID: G1T28-209
  • Secondary ID:
  • NCT ID: NCT04887831
  • NCT Alias:
  • Sponsor: G1 Therapeutics, Inc. - Industry
  • Source: G1 Therapeutics, Inc.

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

Detailed Description


Patients will be randomly assigned (1:1) to receive standard of care platinum-based
chemotherapy (with or without the addition of trilaciclib) administered intravenously (IV) in
21-day cycles followed by standard of care avelumab maintenance therapy (with or without the
addition of trilaciclib) administered IV in 14-day cycles.

Patients enrolled in the study will be eligible to receive 4-6 cycles of platinum-based
chemotherapy, and patients without progressive disease (PD) as per Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete response
[CR], partial response [PR], or stable disease) after platinum-based chemotherapy will be
eligible to receive avelumab maintenance therapy until disease progression, unacceptable
toxicity, withdrawal of consent, Investigator decision, or the end of the trial, whichever
comes first.

Patients will be followed for survival approximately every 3 months after receiving the last
dose of study medication.

Overal Status Start Date Phase Study Type
Recruiting May 30, 2021 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression-Free Survival

Primary Outcome 1 - Time Frame: 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)

Condition:

  • Urothelial Carcinoma
  • Bladder Cancer
  • Myelosuppression Adult
  • Chemotherapy-induced Neutropenia
  • Metastatic Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Age ≥18 years

2. Histologically documented, locally advanced (T4b, any N; or any T, N 2-3) or
metastatic urothelial carcinoma (M1, Stage IV)

3. Measurable disease as defined by RECIST v1.1r/>
4. No prior systemic therapy in the inoperable, locally advanced, or metastatic setting
including chemotherapy, immune checkpoint inhibitor therapy, targeted therapy, or
investigational agents

5. Archival tumor tissue must be available or a fresh biopsy must be obtained, unless
approved by the Medical Monitor

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

7. Adequate organ function as demonstrated by normal laboratory values

Exclusion Criteria:

1. Prior treatment with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137
or CD137 agonists, or cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody
(including ipilimumab), or any other therapeutic antibody or drug specifically
targeting T cell co-stimulation or immune checkpoint pathways in any setting

2. Malignancies other than urothelial carcinoma within 3 years prior to randomization,
except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in
situ of the breast or of the cervix, or low-grade (Gleason ≤6) prostate cancer on
surveillance without any plans for treatment intervention (e.g., surgery, radiation,
or castration)

3. Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring
immediate treatment with radiation therapy or steroids.

4. QTcF interval > 480 msec. For patients with ventricular pacemakers, QTcF > 500 msec

5. Known hypersensitivity or allergy to avelumab, gemcitabine, cisplatin or carboplatin

6. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any
history of anaphylaxis, or uncontrolled asthma

7. Prior hematopoietic stem cell or bone marrow transplantation, or solid organ
transplantation

8. Pregnant or lactating women

9. Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent

10. Current use of immunosuppressive medication, EXCEPT for the following:

1. Intranasal, inhaled, topical steroids, or local steroid injection (e.g.,
intra-articular injection)

2. Systemic corticosteroids at physiological doses ≤10 mg/day of prednisone or
equivalent

3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan
premedication)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Clinical Contact

Role: Study Director

Affiliation: G1 Therapeutics, Inc.

Overall Contact

Name: G1 Therapeutics, Inc. Clinical Contact

Phone: 919-213-9835

Email: clinicalinfo@g1therapeutics.com

Location

Facility Status Contact
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington 99208
United States
Recruiting Monika Chaudhry
509-462-2273