A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy (NCT03122522) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy
United States70 participantsStarted 2017-04-17
Plain-language summary
This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is sufficient for patients with early benefit compared to the usual way of trying to give 4 doses. If patients do not show early benefit after 2 doses, patients will be able to continue with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best interest of the patient.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic diagnosis of unresectable III or stage IV metastatic melanoma.
* Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).
* No prior CTLA-4 or PD-1/PD-L1 therapy for the treatment of metastatic disease.
* ECOG performance status of 0-1.
* Life expectancy ≥ 4 months.
* Screening laboratory parameters:
* White blood cell (WBC) count ≥ 2000/μL;
* Absolute neutrophil count (ANC) ≥ 1500/μL;
* Platelets ≥ 100,000/μL;
* Hemoglobin (Hgb) ≥ 9 g/dL;
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);
* Total bilirubin ≤ 1.5 × ULN (\< 3 mg/dL for subjects with Gilbert's disease);
* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = \[(140 - age in years) x weight in kg x 0.85\] / \[72 x serum creatinine in mg/dL\] Male CrCl = \[(140 - age in years) x weight in kg x 1.00\] / \[72 x serum creatinine in mg/dL\]
* Age ≥ 18 years.
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the with…