Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lun… (NCT04940299) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
United States35 participantsStarted 2021-09-23
Plain-language summary
This phase II trial investigates the side effects of tocilizumab, ipilimumab, and nivolumab in treating patients with melanoma, non-small cell lung cancer, or urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tocilizumab is a monoclonal antibody that may interfere with the immune system to decrease immune-related toxicities. Giving tocilizumab, ipilimumab, and nivolumab may kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.
✓. Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, tumor biopsies, and other requirements of the study.
✓. All consented participants should be registered in the institutional database CORe 2) Type of Participant and Target Disease Characteristics
✓. Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) Version 8 staging system (Appendix A). Patients must consent to BRAF testing or have documented BRAF status as per regionally acceptable V600 mutational status testing. Specifically, 10 melanoma patients will be initially enrolled, and an additional 25 melanoma patients will be enrolled in expansion cohort. Patients with biopsiable disease will have tissue collected including patients in the expansion cohorts. Archival tumor tissue samples may be collected in place of the biopsy after PI consultation. If biopsy is not feasible, or the patient declines to participate due to the biopsy, the patient may still enroll with PI approval.
✓. Treatment-naïve participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant treatment for melanoma with approved agents (eg, BRAF/MEK inhibitors, ipilimumab, nivolumab, pembrolizumab or interferon). Participants who have had recurrence within the 6 months of completing adjuvant treatment are not eligible.
What they're measuring
1
Incidence of dose limiting toxicity
Timeframe: Up to 2 years
2
Occurrence of one or more grade 3 or higher adverse event in a given patient (Cohort 1)
✓. Subjects diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
✓. Subjects must have received one prior line of therapy with an EGFR TKI in the locally advanced/metastatic setting.
✓. Subjects need to meet either A or B. A) Must have received and progressed on an approved first or second generation EGFR TKI (eg, erlotinib or gefitinib \[first generation\] or afatinib \[second generation\]) and must be T790M negative by an approved testing assay on tumor biopsy at the time of progression. B) Patient must have received third generation TKI Osimertinib and progressed on this therapy for study entry. C) TKI needs to be the last therapy. D) Prior chemotherapy received in the neoadjuvant or adjuvant settings will not be considered a line of therapy.
Exclusion criteria
✕. WBC \< 2000/μL
✕. Neutrophils \< 1500/μL
✕. Platelets \< 100,000/μL
✕. Hemoglobin \< 9.0 g/dL NOTE: May not transfuse within 14 days of study treatment initiation to meet eligibility criteria 3a through 3d.
✕. Serum creatinine \> 1.5 x ULN, unless creatinine clearance ≥ 40 mL/min (measured or calculated using the Cockroft-Gault formula) Female CLcr = (140- age in years) x weight in kg x 0.85 72 x serum creatinine in mg/ dL Male CLcr = (140- age in years) x weight in kg x 1.00 72 x serum creatinine in mg/ dL
✕. AST/ALT: \> 3.0 x ULN
✕. Total bilirubin \> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0x ULN)
✕. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg, Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).