NCT04495257

A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)

A Phase I Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Melanoma
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 3mg/kg intravenously (IV) every 3 weeks for the first 4 treatments and then will be given at 360mg every 3 weeks thereafter
DRUG	Ipilimumab	Ipilimumab 1mg/kg intravenously (IV) every 3 weeks for a total of 4 treatments
DRUG	APX005M	APX005M 0.3mg/kg intravenously (IV) every 3 weeks

Timeline

• Start date: 2020-09-14
• Primary completion: 2026-02-28
• Completion: 2026-08-28
• First posted: 2020-07-31
• Last updated: 2025-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study