APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03502330
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APX005M — DRUG
    APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
  • Cabiralizumab — DRUG
    Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
  • Nivolumab — DRUG
    Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.

Study Details

This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of APX005M in combination with nivolumab and cabiralizumab. The phase 1 dose escalation portion of the study will enroll patients with advanced solid tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) in 6 cohorts to determine the recommended phase II dose (RP2D) of APX005M. The phase 1b dose expansion portion will study the triple drug combination separately in the three disease cohorts: melanoma, NSCLC, and RCC.

Key Dates

Start date
Jun 9, 2018
Status verified
Jun 2024
Primary completion
Jan 5, 2022
Completion
May 15, 2024

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Advanced Solid Tumors
    Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
  • Experimental: Cohort 2 Advanced Solid Tumors
    Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
  • Experimental: Cohort 3 Advanced Solid Tumors
    Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
  • Experimental: Cohort 4 Advanced Solid Tumors
    Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
  • Experimental: Cohort 5 Advanced Solid Tumors
    Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
  • Experimental: Cohort 6 Advanced Solid Tumors
    Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
  • Experimental: Cohort 7 Advanced Melanoma
    Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
  • Experimental: Cohort 8 NSCLC
    Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
  • Experimental: Cohort 9 RCC
    Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.

Primary Outcome Measure

Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs) [ Time Frame: From study enrollment up to 12 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06510-

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By research site
Yale Cancer Center· New Haven, CT

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