Phase 2
N=76
Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03558087 ↗Enrolled (actual)
76
Serious AEs
52.6%
Results posted
Jun 2024
Primary outcome: Primary: Clinical Complete Response (CCR) Rate — 43 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug); Gemcitabine (Drug); Cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Matthew Galsky
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Complete Response (CCR) Rate |
43 | — |
| PRIMARY Predict Benefit From Treatment |
0.97 | — |
| SECONDARY Adverse Events |
12; 26; 13; 5; 4; 3 | — |
| SECONDARY Bladder Intact Overall Survival |
NA; 4.53 | — |
| SECONDARY Recurrence-free Survival |
51.52; NA | — |
| SECONDARY Pathologic Complete Response Rate in Patients Undergoing Cystectomy |
1; 3 | — |
| SECONDARY Association Between a Prespecified Panel of Genomic Biomarkers and Benefit From Treatment in Patients Achieving a Clinical Complete Response. |
0.72 | — |
| SECONDARY Overall Survival |
NA; NA | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT03558087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.