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BRIEF TITLE: Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

Neoadjuvant Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing


  • Org Study ID: HCRN GU16-257
  • Secondary ID:
  • NCT ID: NCT03558087
  • NCT Alias:
  • Sponsor: Matthew Galsky - Other
  • Source: Hoosier Cancer Research Network

Brief Summary

This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.

Overal Status Start Date Phase Study Type
Recruiting July 13, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Determine the clinical complete response rate (cT0 or cTa) with gemcitabine, cisplatin, plus nivolumab

Primary Outcome 1 - Time Frame: 24 months

Primary Outcome 2 - Measure: Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.

Primary Outcome 2 - Time Frame: 24 months

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- ECOG Performance Status of ≤ 1 within 28 days prior to registration.

- Histological evidence of clinically localized muscle-invasive urothelial cancer of the
bladder (i.e., ct2-4n0m0). candidate for cystectomy as per treating physician.

- Demonstrate adequate organ function per listed criteria:

- Absolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/L

- Hemoglobin (Hgb): ≥ 9 g/dL

- Platelets: ≥ 100 x 10^9/L

- Calculated creatinine clearance: Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL/min

- Bilirubin: ≤ 1.5 × upper limit of normal (ULN) (except subjects with Gilbert Syndrome,
who can have total bilirubin < 3.0 mg/dL)

- Aspartate aminotransferase (AST) : ≤ 3 × ULN

- Alanine aminotransferase (ALT) : ≤ 3 × ULN

- All subjects must have adequate archival tissue submitted prior to registration (i.e.,
at least 15 unstained slides or paraffin block).

- Women of childbearing potential (WOCBP) must use appropriate method(s) of
contraception.

- Women of childbearing potential must have a negative serum or urine pregnancy within 7
days prior to C1D1.

- Men who are sexually active with WOCBP must use any contraceptive method with a
failure rate of less than 1% per year.

Exclusion Criteria:

- Prior treatment with systemic chemotherapy for muscle-invasive urothelial cancer of
the bladder

- Active infection requiring systemic therapy

- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the
mother is being treated on study).

- Any serious or uncontrolled medical disorder that, in the opinion of the investigator,
may increase the risk associated with study participation or study drug
administration, impair the ability of the subject to receive protocol therapy, or
interfere with the interpretation of study results.

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured.

- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo,
type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only
requiring hormone replacement, psoriasis not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted
to enroll.

- Subjects with a condition requiring systemic treatment with either corticosteroids (>
10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of study drug administration. Inhaled or topical steroids and adrenal replacement
doses > 10 mg daily prednisone equivalents are permitted in the absence of active
autoimmune disease.

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or
any other antibody or drug specifically targeting T-cell co-stimulation or immune
checkpoint pathways.

- Grade ≥ 2 neuropathy (NCI CTCAE version 4).

- Prior radiation therapy for bladder cancer

- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus
ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or
chronic infection.

- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS).

- Evidence of interstitial lung disease or active, non-infectious pneumonitis.

- Solid organ or allogeneic stem cell transplant
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Matthew Galsky, MD

Role: Principal Investigator

Affiliation: Icahn School of Medicine at Mount Sinai

Overall Contact

Name: Matthew Galsky, MD

Phone: 212-659-5599

Email: matthew.galsky@mssm.edu

Location

Facility Status Contact
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center
New York, New York 10029
United States
Recruiting Matthew Galsky, M.D.
212-241-8214
matthew.galsky@mssm.edu