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Study of Avelumab-M3814 Combinations

NCT03724890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-04-10

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2021-09-01
Completion
2022-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724890 on ClinicalTrials.gov