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A Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052205
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 6, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE June 9, 2017
Actual Primary Completion Date July 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors
Official Title  ICMJE A Phase 1b Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)
Brief Summary This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory Solid Tumors
  • Melanoma
Intervention  ICMJE Drug: IMO-2125
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 Arms  ICMJE Experimental: IMO-2125 at escalating dose levels
IMO-2125 at escalating dose levels by intratumoral injection
Intervention: Drug: IMO-2125
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2019)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
40
Actual Study Completion Date  ICMJE October 4, 2019
Actual Primary Completion Date July 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.
  2. 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. 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.

  3. a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy.

    b) 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.

  4. Patients must be 18 years of age or older.
  5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
  6. Patients must meet the following laboratory criteria:

    1. Absolute neutrophil count ANC ≥1.5 x 109/L (≥1500/mm3)
    2. Platelet count ≥75 x 109/L (≥75,000/mm3)
    3. Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)
    4. Serum creatinine ≤1.5 x ULN or calculated 24-hour creatinine clearance ≥60 mL/minute
    5. Aspartate aminotransferase (AST) ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement
    6. 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)
  7. 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.
  8. Patients must be willing and able to provide signed informed consent and comply with the study protocol.

Exclusion Criteria:

  1. 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).

  2. Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
  3. Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis; e.g. steroids.
  4. Patients with active autoimmune disease requiring disease-modifying therapy.
  5. Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).
  6. 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).
  7. Patients with active infections requiring systemic treatment.
  8. Patients who are known to be hepatitis B surface antigen positive.
  9. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
  10. Women who are pregnant or breastfeeding.
  11. 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).
  12. Patients with impaired cardiac function or clinically significant cardiac disease:

    1. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy
    2. Unstable angina pectoris ≤6 months prior to study participation
    3. Acute myocardial infarction ≤6 months prior to study participation
    4. Other clinically significant heart disease (i.e., Grade ≥3 hypertension, history of labile hypertension, or poor compliance with an anti-hypertensive regimen)
  13. Have not recovered (to baseline or Grade ≤1) from toxicity associated with prior treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03052205
Other Study ID Numbers  ICMJE 2125-RST-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Idera Pharmaceuticals, Inc.
Study Sponsor  ICMJE Idera Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Idera Medical Director Idera Pharmaceuticals, Inc.
PRS Account Idera Pharmaceuticals, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP