CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
Public ClinicalTrials.gov record NCT03123783. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03123783
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 9, 2017
- Primary completion
- Nov 15, 2020
- Completion
- Nov 15, 2020
- Last update posted
- Dec 25, 2023
2017 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| City of Hope | Duarte | California | 91010 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Hem-Onc Associates of the Treasure Coast | Port Saint Lucie | Florida | 32952 | — |
| University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) | Baltimore | Maryland | 21201 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| SUNY Upstate Medical Hospital | Syracuse | New York | 13210 | — |
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | — |
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Fox Chase Center | Rockledge | Pennsylvania | 19046 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03123783, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 25, 2023 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03123783 live on ClinicalTrials.gov.