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A Study to Evaluate the Safety and Effectiveness of ILIxadencel Administered Into Tumors in Combination With Checkpoint Inhibitor (CPI) in Patients With ADvanced Cancer

NCT03735290 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-03-16

No results posted yet for this study

Summary

Patients in the Phase 1b part of the study will be treated with ilixadencel at an increasing dose and frequency, in combination with standard doses and schedules of checkpoint inhibitor (CPI) pembrolizumab. The Phase 1b study will determine the optimal dose and schedule of ilixadencel. Patients in the Phase 2 part of the study will be randomly assigned to receive either ilixadencel (at the dose determined in Phase 1b) combined with the CPI, or only the CPI.

Note: Recruitment to Phase 1b of the study has been completed.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

ilixadencel

Intra-tumoral injection

DRUG

Pembrolizumab

Administered intravenously over 30 minutes, every 3 weeks, at a dose of 200 mg

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Mendus

    lead INDUSTRY

Principal Investigators

  • Petra Domeij · Mendus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2021-12-03
Completion
2021-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03735290 on ClinicalTrials.gov