AzTrials
AzTrials

Carcinoma, Squamous Cell of Head and NeckPhase 1ILIADNCT03735290

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

A Phase 1 study testing ilixadencel and Pembrolizumab in people with Carcinoma, Squamous Cell of Head and Neck and Gastric Adenocarcinoma, run by Mendus at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ilixadencel and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
5 sitesUnited States
Study dates
14 Jan 2019to 3 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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).
  • Other protocol-defined inclusion/exclusion criteria could apply.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Site 1004

    Chapel Hill, North Carolina, 27514

  • Site 1009

    Cleveland, Ohio, 44106

  • Site 1010

    Coral Gables, Florida, 33124

  • Site 1006

    Iowa City, Iowa, 52242

  • Site 1011

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: A Randomized, Open-label, Multi-center, Phase 1b/2 Trial Evaluating the Safety and Efficacy of Intratumorally-administered Ilixadencel in Combination With Checkpoint Inhibitor (CPI) in Advanced Cancer Subjects Who Are Candidates for CPI Therapy

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.

Read the detailed description

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.

Being tested
ilixadencel, Pembrolizumab
Keywords
immunotherapy, ilixadencel, checkpoint inhibitor, allogeneic, somatic cell therapy, dendritic cell, intratumoral, in situ
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ilixadencelBiological

    Intra-tumoral injection

  • PembrolizumabDrug

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

Study groups in NCT03735290
Study groupRoleWhat they receive
Phase 1b: Cohort 1, ilixadencel + pembrolizumabExperimental3 x 10⁶ DCs (Dendritic Cells) of ilixadencel, 2x over 4 weeks (w). Pembrolizumab I.V. q3w
Receives: Biological: ilixadencel; Drug: Pembrolizumab
Phase 1b: Cohort 2, ilixadencel + pembrolizumabExperimental10 x 10⁶ DCs of ilixadencel, 2x over 4 weeks. Pembrolizumab I.V. q3w
Receives: Biological: ilixadencel; Drug: Pembrolizumab
Phase 1b: Cohort 3, ilixadencel + pembrolizumabExperimental10 x 10⁶ DCs of ilixadencel, 3x over 10 weeks. Pembrolizumab I.V. q3w
Receives: Biological: ilixadencel; Drug: Pembrolizumab
Phase 1b: Cohort 4, ilixadencel + pembrolizumabExperimentalIlixadencel 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
Receives: Biological: ilixadencel; Drug: Pembrolizumab
Phase 2 exp. cohorts HNSCC/NSCLC/Gastric/GEJExperimentalSubjects 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.
Receives: Biological: ilixadencel; Drug: Pembrolizumab
Phase 2 comparator cohorts HNSCC/NSCLC/Gastric/GEJActive comparatorSubjects with HNSCC, NSCLC, gastric/GEJ adenocarcinoma receiving active treatment with pembrolizumab I.V. q3w according to currently approved doses and indications.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events (AEs) (Phase 1b)

    Number of adverse events

    Measured: Up to Week 27

  2. Severity of adverse events (AEs) (Phase 1b)

    Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to Week 27

  3. Number of Dose Limiting Toxicities (DLTs) (Phase 1b)

    Dose Limiting Toxicities measured using CTCAE v5.0 and protocol DLT definition.

    Measured: Up to Week 27

  4. Number of subjects with clinically significant laboratory test abnormalities (Phase 1b)

    Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to Week 27

  5. Number of subjects with vital sign abnormalities (Phase 1b)

    Vital signs grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to Week 27

  6. Antitumor Objective Response Rate (ORR) (Phase 2)

    Antitumor activity of ilixadencel plus CPI (checkpoint inhibitor) in each tumor type, centrally assessed using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1

    Measured: Up to Week 27

Secondary outcomes (12)

  1. Antitumor Objective Response Rate (ORR) RECIST 1.1 (Phase 1b and Phase 2)

    Antitumor activity of ilixadencel plus CPI (checkpoint inhibitor) in each tumor type, investigator and centrally assessed using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1

    Measured: Up to Week 27

  2. Antitumor Objective Response Rate (ORR) iRECIST (Phase 1b and Phase 2)

    Antitumor activity of ilixadencel plus CPI (checkpoint inhibitor) in each tumor type, investigator assessed using iRECIST (Immune Response Evaluation Criteria in Solid Tumors)

    Measured: Up to Week 27

  3. Clinical Benefit Rate (Phase 1b and Phase 2)

    Rate of complete and partial response and stable disease by investigator and centrally assessed RECIST (Response Evaluation Criteria in Solid Tumors) v1.1

    Measured: Up to Week 27

  4. Duration of response (Phase 1b and Phase 2)

    Measured in weeks. Assessed using RECIST v1.1 and iRECIST

    Measured: Up to 24 months after Cycle 1 Day 1

  5. Time to Progression (TTP) (Phase 1b and Phase 2)

    Measured in weeks. Assessed using RECIST v1.1 and iRECIST

    Measured: Up to 24 months after Cycle 1 Day 1

  6. Progression-free Survival (PFS) (Phase 1b and Phase 2)

    Measured in weeks. Centrally assessed using RECIST v1.1

    Measured: Up to 24 months after Cycle 1 Day 1

  7. Overall Survival (OS) (Phase 1b and Phase 2)

    Measured in months

    Measured: Up to 5 years

  8. Frequency of adverse events (AEs) (Phase 2)

    Number of adverse events

    Measured: Up to Week 27

  9. Severity of adverse events (AEs) (Phase 2)

    Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to Week 27

  10. Number of Dose Limiting Toxicities (DLTs) (Phase 2)

    Dose Limiting Toxicities measured using CTCAE v5.0 and protocol DLT definition.

    Measured: Up to week 27

  11. Number of subjects with clinically significant laboratory test abnormalities (Phase 2)

    Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to Week 27

  12. Number of subjects with vital sign abnormalities (Phase 2)

    Vital signs grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Up to Week 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study start14 Jan 2019
  3. Primary completion3 Dec 2021
  4. Study completion3 Dec 2021

Why it stopped: Decision made not to move to Phase 2

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Single arm phase 1b. Randomized phase 2.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735290
Sponsor's protocol ID
IM-202
Acronym
ILIAD
Status last verified
Mar 2022
First submitted
7 Nov 2018
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ilixadencel and Pembrolizumab in people with Carcinoma, Squamous Cell of Head and Neck and Gastric Adenocarcinoma, run by Mendus at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Decision made not to move to Phase 2). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) (Phase 1b) (time frame: Up to Week 27). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03735290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in