A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
Public ClinicalTrials.gov record NCT02994953. 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 Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study consisted of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase evaluated the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase assessed the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who had completed the combination treatment of avelumab at a given dose level of M9241, a safety review was performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects were treated with escalating doses of M9241 with avelumab intravenous (IV).
Study identification
- NCT ID
- NCT02994953
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Interventions
- Avelumab Drug
- M9241 Drug
- Avelumab (Once weekly) Drug
- M9241 (MTD) Drug
- Avelumab (Expansion cohort) Drug
Drug
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
- Jan 30, 2017
- Primary completion
- Oct 7, 2020
- Completion
- Oct 7, 2020
- Last update posted
- Sep 19, 2024
2017 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Cancer Associates for Research & Excellence, Inc. | San Diego | California | 92111 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| St Joseph Heritage Healthcare | Santa Rosa | California | 95403 | — |
| Yale University Institutional Review Board | New Haven | Connecticut | 06520 | — |
| Holy Cross Hospital Inc. | Fort Lauderdale | Florida | 33308 | — |
| Hematology - Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Metairie Oncologists, LLC | Metairie | Louisiana | 70006 | — |
| National Cancer Institute | Bethesda | Maryland | 20892 | — |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| UC Health, LLC. | Cincinnati | Ohio | 45229 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Cedar Sinai Medical Center | Ashland | Oregon | 97520 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Mary Crowley Cancer Research Centers | Dallas | Texas | 75251 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05405 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
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 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02994953, 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 Sep 19, 2024 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02994953 live on ClinicalTrials.gov.