CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
APX005M +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03123783
NCT03123783Phase 2Completed
CompareCT.gov

A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma

Apexigen America, Inc.·interventional·Posted Apr 21, 2017·Updated Dec 26, 2023

In Brief

A Phase 2 clinical trial evaluating APX005M and Nivolumab for Cancer and 4 related conditions. Completed, enrolled 140 participants across 23 sites in 2 countries.

Detailed Summary

This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Non Small Cell Lung Cancer Metastatic, Metastatic Melanoma, Neoplasm of Lung, Melanoma
CountriesSpain, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartJul 10, 2017
Primary CompletionNov 16, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.2 years ago

Interventions

APX005Mdrug

APX005M is a CD40 agonistic monoclonal antibody

Nivolumabdrug

Nivolumab is an immune checkpoint (PD-1) blocking antibody