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

NCT02994953 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-09-20

Study results available
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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

Interventions

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).

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-10-08
Completion
2020-10-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Hungary
  • Italy
  • Netherlands
  • Spain

Study Locations

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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 NCT02994953 on ClinicalTrials.gov