NCT02994953

A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Avelumab	Participants received avelumab intravenous (IV) infusion once a week on Day 1 and Day 15 of each cycle.
DRUG	M9241	Participants received Subcutaneous (SC) injection of M9241 in escalating doses on Day 1 of each cycle.
DRUG	Avelumab (Once weekly)	Participants received avelumab once weekly in combination with M9241 every 4 weeks at M9241 maximum tolerated dose (MTD) for first 12 weeks followed by avelumab once every 2 weeks plus M9241 once every 4 weeks at M9241 MTD until a criterion for treatment discontinuation has been met.
DRUG	M9241 (MTD)	Participants received M9241 at M9241 MTD once every 4 weeks until a criterion for treatment discontinuation has been met.
DRUG	Avelumab (Expansion cohort)	Participants in the expansion cohorts received Induction Therapy (Avelumab once weekly + M9241 once every 4 weeks) through Cycle 3 (for 12 weeks) then starting at Cycle 4, Continuation Therapy (Avelumab once every 2 weeks + M9241 once every 4 weeks).

Timeline

• Start date: 2017-01-31
• Primary completion: 2020-10-08
• Completion: 2020-10-08
• First posted: 2016-12-16
• Last updated: 2024-09-20
• Results posted: 2024-09-20

Locations

33 sites across 7 countries: United States, Belgium, France, Hungary, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study