Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT04495257
Brief Summary:
This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.
Detailed Description:
This trial is a phase 1 study to evaluate the safety and tolerability of APX005M in combination with nivolumab and ipilimumab. The study will enroll patients with advanced solid tumors (melanoma, RCC) to determine the recommended phase II dosing (RP2D) of APX005M in combination with ipilimumab 1mg/kg and nivolumab 3 mg/kg (IPI1 NIVO3) every 3 weeks for four cycles followed by APX005M in combination with nivolumab 360mg every 3 weeks. APX005M will be administered at a dose of 0.1 mg/kg every 3 weeks in Dose Level 1 (DL1) and escalated to 0.3 mg/kg every 3 weeks in Dose Level 2 (DL2) (Table 1). The IPI1 NIVO3 regimen is approved for patients with metastatic RCC.
APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. Nivolumab is a humanized IgG4 monoclonal antibody directed against PD-1. Ipilimumab is a humanized IgG1κ monoclonal antibody directed against CTLA-4.
Primary Objective
* To assess the safety and tolerability of APX005M in combination with nivolumab and ipilimumab
* To determine the recommended RP2D of APX005M in combination with nivolumab and ipilimumab in patients with unresectable metastatic melanoma or renal cell carcinoma.
Secondary Objective
• Determine rate and pattern of AEs in patients treated with APX005M in combination with nivolumab and ipilimumab
Study:
NCT04495257
Study Brief:
Protocol Section:
NCT04495257