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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2021-12-03

Brief Summary

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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.

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Detailed Description

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Despite improvements achieved with the use of CPIs, 50-80% of cancer patients do not respond to this therapy. There is growing evidence that combining CPIs with other forms of immunotherapy has the potential to improve the desired effects of both CPIs and immunotherapies. This study looks at the safety and effectiveness of the immunotherapy ilixadencel when used in combination with a CPI. A Dose-escalation Committee (DEC) will monitor the study for any significant safety issues during Phase 1b.

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

The study did not move forward to Phase 2.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single arm phase 1b. Randomized phase 2.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1b: Cohort 1, ilixadencel + pembrolizumab

3 x 10⁶ DCs (Dendritic Cells) of ilixadencel, 2x over 4 weeks (w). Pembrolizumab I.V. q3w

Group Type EXPERIMENTAL

ilixadencel

Intervention Type BIOLOGICAL

Intra-tumoral injection

Pembrolizumab

Intervention Type DRUG

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

Phase 1b: Cohort 2, ilixadencel + pembrolizumab

10 x 10⁶ DCs of ilixadencel, 2x over 4 weeks. Pembrolizumab I.V. q3w

Group Type EXPERIMENTAL

ilixadencel

Intervention Type BIOLOGICAL

Intra-tumoral injection

Pembrolizumab

Intervention Type DRUG

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

Phase 1b: Cohort 3, ilixadencel + pembrolizumab

10 x 10⁶ DCs of ilixadencel, 3x over 10 weeks. Pembrolizumab I.V. q3w

Group Type EXPERIMENTAL

ilixadencel

Intervention Type BIOLOGICAL

Intra-tumoral injection

Pembrolizumab

Intervention Type DRUG

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

Phase 1b: Cohort 4, ilixadencel + pembrolizumab

Ilixadencel 3 times over 10 weeks: 1st dose 20 x 10⁶ DCs ilixadencel; 2nd dose 10 x 10⁶ DCs; 3rd dose 10 x 10⁶ DCs. Pembrolizumab I.V. q3w

Group Type EXPERIMENTAL

ilixadencel

Intervention Type BIOLOGICAL

Intra-tumoral injection

Pembrolizumab

Intervention Type DRUG

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

Phase 2 exp. cohorts HNSCC/NSCLC/Gastric/GEJ

Subjects with HNSCC, NSCLC, gastric or gastroesophageal junction (GEJ) adenocarcinoma. ilixadencel administered intra-tumorally up to 3 times over 10 weeks; dose determined after Phase 1b. Pembrolizumab I.V. q3w according to currently approved doses and indications.

Group Type EXPERIMENTAL

ilixadencel

Intervention Type BIOLOGICAL

Intra-tumoral injection

Pembrolizumab

Intervention Type DRUG

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

Phase 2 comparator cohorts HNSCC/NSCLC/Gastric/GEJ

Subjects with HNSCC, NSCLC, gastric/GEJ adenocarcinoma receiving active treatment with pembrolizumab I.V. q3w according to currently approved doses and indications.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

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

Interventions

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ilixadencel

Intra-tumoral injection

Intervention Type BIOLOGICAL

Pembrolizumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must provide written informed consent.
* Must have histologically confirmed and specific (Human Papilloma Virus) HPV-positive or HPV-negative squamous cell carcinoma of the head and neck (SCCHN), non-small-cell lung cancer (NSCLC) or gastric or gastroesophageal junction (GEJ) adenocarcinoma. Patients with other tumor types who are candidates for pembrolizumab therapy (according to the FDA-approved prescribing information at the time of inclusion) can also be enrolled in Phase 1b. Tumor histology and most recent pathology report must be in subject's medical record. Tumor samples and/or biopsies will not be collected as part of this study.
* Eligible for pembrolizumab treatment per country-specific label and per physician's decision.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
* Adequate organ function.
* Women of childbearing potential must follow contraceptive requirements; must have a negative pregnancy blood test at screening, and a negative blood or urine pregnancy test within 24 hours before each dose of ilixadencel; and must not be breastfeeding.
* Male subjects must agree to use condoms from screening until 90 days after the last dose of ilixadencel, or must have a female partner using a highly effective method of contraception as described above.

Exclusion Criteria

* Prior history of invasive malignancy, unless complete remission has been achieved for at least 3 years and no additional therapy is required except for hormonal therapy or bisphosphonates.
* Active or previously untreated brain and/or leptomeningeal metastasis.
* Active autoimmune disease, pneumonitis or interstitial lung disease.
* Certain heart conditions including, but not limited to: Congestive heart failure; uncontrolled hypertension; unstable angina pectoris; pericarditis; myocarditis; mycardial infarction 6 months prior to study.
* Systemic immunosuppression except for replacement therapy.
* Life expectancy of less than 3 months.
* Any prior treatment with ilixadencel or prior treatment with anticancer agents (except pembrolizumab or other CPI for subjects in Phase 1b) within 4 weeks of starting study medication.
* Major surgery or significant traumatic injury within 4 weeks before study start.
* Known infection with human immunodeficiency virus (HIV).
* Active tuberculosis; active infection requiring anti-infective therapy (hepatitis with a negative viral load on maintenance will not be excluded).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No