Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG … (NCT03106610) | Clinical Trial Compass
TerminatedPhase 1
Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy
Stopped: Slow Accrual
United States1 participantsStarted 2017-07-07
Plain-language summary
The goal of this clinical research study is to learn about the tolerability of nivolumab in patients who have bladder cancer, were previously treated with BCG immunotherapy, and who have a cystectomy (removal of all or part of the bladder) scheduled as part of their standard care.
This is an investigational study. Nivolumab is FDA approved and commercially available to treat metastatic (has spread) melanoma or non-small cell lung cancer (NSCLC) after the disease has gotten worse while receiving platinum-based chemotherapy. The use of nivolumab in this study is considered investigational.
Up to 10 participants will take part in this study. All will be enrolled at MD Anderson.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients included in the study must be \>/= 18 years old.
✓. Histological or cytological evidence of transitional cell carcinoma or carcinoma in situ of the urothelium involving the bladder or prostatic urethra following treatment with BCG with the recommendation to proceed for cystectomy. Minor histologic variants (\< 50% overall) are acceptable. Diagnosis must be within 1 year of study entry.
✓. Patent must have BCG unresponsive non-muscle-invasive bladder cancer defined as: Persistent or recurrence of CIS within 12 months, or recurrence of CIS with Ta/T1 papillary disease within 12 months, or recurrence of high grade Ta or T1 papillary disease alone within 6 months of receiving at least two courses of intravesical BCG (at least five of six induction doses and at least two doses of either a maintenance course of BCG or a 2nd re-induction of BCG; or T1 high-grade disease at the first evaluation following induction of BCG alone (at least five of six induction doses).
✓. Subjects must have received intravesical treatment with at least two doses of BCG within six months of nivolumab treatment initiation.
✓. Evaluable tumor tissue (archived or new biopsy) must be available for pre-treatment biomarker analysis and baseline immune monitoring studies
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
✓. Screening laboratory values must meet the following criteria and must be obtained within 14 days prior to first dose: a) WBC \>/= 2000/µL; b) Neutrophils \>/= 1500/µL; c) Platelets \>/= 100 x 10\^3/mcl; d) Hemoglobin \>/= 9.0 g/dL; e) AST and ALT \</= 3 x ULN; f) Total Bilirubin \</= 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
What they're measuring
1
Safety of Nivolumab in Subjects Previously Treated with Intravesical Bacillus Calmette-Guerin (BCG) Immunotherapy assessed per NCI CTCAE version 4
✓. Inclusion 6) continued; g.Serum creatinine \</=1.5 x ULN or creatinine clearance (CrCl) \>/=30 mL/min (using the Cockcroft-Gault formula): 1) Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL; 2) Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL
Exclusion criteria
✕. Patients with high risk muscle invasive urothelial carcinoma (hydronephrosis, palpable mass on examination under anesthesia,muscle invasive urothelial carcinoma with lymphovascular invasion on pathologic specimen, \>T3 disease) or those with lymph node positive or metastatic disease are to be excluded.
✕. 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, such as basal or squamous cell skin cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast for example.
✕. 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-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, anti-CD137, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
✕. All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 4).
✕. Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.