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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04495257
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Jun 2025
Primary completion
Mar 4, 2026
Completion
Mar 4, 2026

Study Design

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

Arms

  • Experimental: Dose Level 1 (DL1)
    DL1 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.1mg/kg for the induction phase. After 4 cycles, participants will be treated with 360mg of nivolumab and APX005M every 3 weeks.
  • Experimental: Dose Level 2 (DL2)
    DL2 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.3mg/kg for the induction phase. After 4 cycles we will treat with 360mg of nivolumab and APX005M every 3 weeks.

Primary Outcome Measure

Dose-limiting toxicities [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06519-
Yale New Haven HospitalNew HavenConnecticut06520-

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