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

NCT04495257 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-10-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Apexigen America, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Harriet Kluger, MD · Yale University

  • Sarah Weiss, MD · Yale University

  • Kelly Olino, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2026-02-28
Completion
2026-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495257 on ClinicalTrials.gov