NCT03724890

Study of Avelumab-M3814 Combinations

A Multicenter, Open-Label, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination With Avelumab With and Without Palliative Radiotherapy in Participants With Selected Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study was to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.

Conditions

• Oncology
• Solid Tumors

Interventions

Type	Name	Description
DRUG	M3814	Participants received M3814 twice daily (BID) continuously starting from Day 1 until progressive disease (PD) or unacceptable toxicity.
DRUG	M3814	Participants received M3814 concomitantly with RT once (QD) daily starting Day 1 for 5 days per week for 2 weeks in total.
DRUG	Avelumab	Participants received avelumab once every 2 weeks (Q2W) starting from Day 1 until PD or unacceptable toxicity.
RADIATION	Radiotherapy	Participants received radiotherapy at the dose of 3 grays (Gy) per day starting Day 1 for 5 days per week for 2 weeks.

Timeline

• Start date: 2018-11-27
• Primary completion: 2021-09-01
• Completion: 2022-08-17
• First posted: 2018-10-30
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study