Refractory Solid TumorsPhase 1ILLUMINATE-101NCT03052205
A Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors
A Phase 1 study testing IMO-2125 in people with Refractory Solid Tumors and Melanoma, run by Idera Pharmaceuticals, Inc. at 12 sites in 2 countries.
Trial summary
This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Solid Tumors, Melanoma
- What is being tested?
- IMO-2125
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 9 Jun 2017to 4 Oct 2019
- 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
- Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.
- Patients who have a diagnosis for which a PD-(L)-1 inhibitor has been approved must have previously received treatment with one of these therapies.
- Melanoma Dose Expansion: Patients must have histologically confirmed metastatic melanoma (ocular melanoma not included) which has progressed on or after treatment with a PD-(L)1 inhibitor.
- a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy.
- Melanoma Expansion Cohort: Patients must have at least one target lesion by Response Evaluation Criteria for Solid Tumors (RECIST v1.1), with at least one lesion accessible for intratumoral injection. Tumor biopsies are not required in the expansion cohort.
- Patients must be 18 years of age or older.
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- Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
- Patients must meet the following laboratory criteria:
- Absolute neutrophil count ANC ≥1.5 x 109/L (≥1500/mm3)
- Platelet count ≥75 x 109/L (≥75,000/mm3)
- Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)
- Serum creatinine ≤1.5 x ULN or calculated 24-hour creatinine clearance ≥60 mL/minute
- Aspartate aminotransferase (AST) ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement
- Total bilirubin ≤1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 μmol/L)
- Women of childbearing potential and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 4 weeks after the last dose of study drug.
- Patients must be willing and able to provide signed informed consent and comply with the study protocol.
Who cannot join
- Patients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility.
- Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).
- Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
- Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis; e.g. steroids.
- Patients with active autoimmune disease requiring disease-modifying therapy.
- Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).
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- Patients with another primary malignancy that has not been in remission for at least 3 years, unless approved by the Idera Medical Monitor. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
- Patients with active infections requiring systemic treatment.
- Patients who are known to be hepatitis B surface antigen positive.
- Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
- Women who are pregnant or breastfeeding.
- Patients with known central nervous system, meningeal, or epidural disease. Patients with stable brain metastases following definitive local treatment are eligible if steroid requirement is <10 mg/day of prednisone (or equivalent).
- Patients with impaired cardiac function or clinically significant cardiac disease:
- New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy
- Unstable angina pectoris ≤6 months prior to study participation
- Acute myocardial infarction ≤6 months prior to study participation
- Other clinically significant heart disease (i.e., Grade ≥3 hypertension, history of labile hypertension, or poor compliance with an anti-hypertensive regimen)
- Have not recovered (to baseline or Grade ≤1) from toxicity associated with prior treatment.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
St. Luke's Hospital
Easton, Pennsylvania, 18045
MD Anderson Cancer Center
Houston, Texas, 77030
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
University of California San Francisco (UCSF)
San Francisco, California, 94143
Scottsdale Healthcare Hospitals DBA Honor Health
Scottsdale, Arizona, 85258
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Israel4 sites
Rambam Medical Center
Haifa, 3109601
Hadassah Medical Center
Jerusalem, 9112001
Rabin Medical Center Beilinson Campus
Petah Tikva, 49100
The Ella Lemelbaum Institute for Immuno-Oncology
Ramat Gan, 5265601
About this study
Official title: A Phase 1b Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)
This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.
- Conditions
- Refractory Solid Tumors, Melanoma
- Being tested
- IMO-2125
- Keywords
- ILLUMINATE-101, melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMO-2125Drug
IMO-2125 will be administered by intratumoral injection on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
| Study group | Role | What they receive |
|---|---|---|
| IMO-2125 at escalating dose levels | Experimental | IMO-2125 at escalating dose levels by intratumoral injection Receives: Drug: IMO-2125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Number of patients with treatment-related adverse events as assessed by CTCAE to determine the recommended Phase 2 dose (RP2D).
Measured: 51 weeks of treatment
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Objective response rate
Measured: Assessed every 6 weeks for duration of study participation, which is estimated to be 51 weeks
Melanoma Expansion Cohort: Objective response rate
Measured: Assessed every 9 weeks for duration of study participation, which is estimated to be 51 weeks
Melanoma Expansion Cohort: Number of patients with treatment-related adverse events as assessed by CTCAE
Measured: 51 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start9 Jun 2017
- Primary completion24 Jul 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Idera Medical Director, Study director, Idera Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052205
- Sponsor's protocol ID
- 2125-RST-101
- Acronym
- ILLUMINATE-101
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)
- ClinicalTrials.gov ID
- NCT03052205
- Acronym / sponsor ID
- ILLUMINATE-101 / 2125-RST-101
- Conditions
- Refractory Solid Tumors, Melanoma
- Keywords
- ILLUMINATE-101, melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMO-2125 at escalating dose levels | Experimental | Drug: IMO-2125IMO-2125 at escalating dose levels by intratumoral injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.
- Patients who have a diagnosis for which a PD-(L)-1 inhibitor has been approved must have previously received treatment with one of these therapies.
- a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy.
- Patients must be 18 years of age or older.
- Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
Key exclusion criteria (18 listed)
- Patients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility.
- Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).
- Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
- Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis; e.g. steroids.
- Patients with active autoimmune disease requiring disease-modifying therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMO-2125IMO-2125 will be administered by intratumoral injection on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle. | Drug | IMO-2125 at escalating dose levels |
Primary outcome
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Number of patients with treatment-related adverse events as assessed by CTCAE to determine the recommended Phase 2 dose (RP2D).
Time frame: 51 weeks of treatment
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Objective response rate
Time frame: Assessed every 6 weeks for duration of study participation, which is estimated to be 51 weeks
Melanoma Expansion Cohort: Objective response rate
Time frame: Assessed every 9 weeks for duration of study participation, which is estimated to be 51 weeks
Melanoma Expansion Cohort: Number of patients with treatment-related adverse events as assessed by CTCAE
Time frame: 51 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idera Medical Director study director
Idera Pharmaceuticals, Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMO-2125 in people with Refractory Solid Tumors and Melanoma, run by Idera Pharmaceuticals, Inc. at 12 sites in 2 countries.
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 16 inclusion and 18 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: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Number of patients with treatment-related adverse events as assessed by CTCAE to determine the recommended Phase 2 dose (RP2D). (time frame: 51 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2020.