Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301) (ILLUMINATE-301)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445533
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE February 26, 2018
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE May 30, 2018
Estimated Primary Completion Date June 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • Compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone [ Time Frame: OS is measured from the date of randomization to the date of death from any cause (up to 56 months). ]
    Efficacy measured by overall survival (OS)
  • Compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone [ Time Frame: Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months). ]
    Efficacy measure by overall response rate (ORR)
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • Compare the efficacy (overall survival [OS]) of IMO-2125 in combination with ipilimumab versus ipilimumab alone [ Time Frame: OS is measured from the date of randomization to the date of death from any cause (up to 48 months). ]
  • Compare the efficacy (overall response rate [ORR]) of IMO-2125 in combination with ipilimumab versus ipilimumab alone [ Time Frame: Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months). ]
Change History Complete list of historical versions of study NCT03445533 on ClinicalTrials.gov Archive Site
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 IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Official Title  ICMJE A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Brief Summary A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Detailed Description A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on anti-PD-1
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE
  • Drug: Ipilimumab
    4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
    Other Name: Yervoy®
  • Drug: IMO-2125
    IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24.
  • Drug: Ipilimumab
    Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11.
    Other Name: Yervoy
Study Arms  ICMJE
  • Experimental: Arm A: ipilimumab
    ipilimumab 3 mg/kg intravenous
    Intervention: Drug: Ipilimumab
  • Experimental: Arm B: IMO-2125 plus ipilimumab
    IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous
    Interventions:
    • Drug: IMO-2125
    • Drug: Ipilimumab
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2019)
454
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2018)
308
Estimated Study Completion Date  ICMJE September 3, 2021
Estimated Primary Completion Date June 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must be willing and able to sign the informed consent and comply with the study protocol.
  2. Subjects must be ≥18 years of age.
  3. Subjects must have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.
  4. Patients must have confirmed progression during or after treatment with a PD-1 inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab. Confirmed progression is defined as:

    • Radiological progression (confirmed at least 4 weeks after the initial scan showing PD); or
    • (For progression based solely on worsening of non-target or new, non-measurable disease) confirmation by an additional scan at least 4 weeks after the initial scan unless it is accompanied by correlative symptoms.

    In addition, all the following must hold:

    1. No intervening anti-cancer therapy between the last course of PD-1 inhibitor treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
    2. The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
    3. If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.
    4. Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy.
  5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  6. Patients must meet the following laboratory criteria:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/mm3)
    2. Platelet count ≥ 75 x 10^9/L (75,000/mm3)
    3. Hemoglobin ≥ 8.0 g/dL (4.96 mmol/L)
    4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/minute
    5. Aspartate aminotransferase (AST) ≤ 2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; AST/ALT < 5 x ULN if liver involvement
    6. Serum bilirubin ≤ 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
  7. Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 90 days after the last dose of either ipilimumab or IMO-2125, whichever is later.
  8. WOCBP must have a negative pregnancy test (serum or urine).

Exclusion Criteria:

  1. Ocular melanoma.
  2. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.
  3. Prior ipilimumab treatment with the exception of adjuvant treatment completed ≥6 months prior to enrollment
  4. Systemic treatment with interferon (IFN)-α within the previous 6 months.
  5. Known hypersensitivity to any oligodeoxynucleotide.
  6. Active autoimmune disease requiring disease-modifying therapy at the time of Screening.
  7. Subjects requiring systemic steroid therapy receiving >10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study.
  8. Subjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of 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).
  9. Active systemic infections requiring antibiotics
  10. Active hepatitis A, B, or C infection.
  11. Known diagnosis of human immunodeficiency virus (HIV) infection.
  12. Women who are pregnant or breastfeeding.
  13. Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures.
  14. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for ≥4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone ≤10 mg/day or equivalent
  15. Impaired cardiac function or clinically significant cardiac disease.
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: Idera Study Monitor 877-888-6550 ext 2 patientinfo@iderapharma.com
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03445533
Other Study ID Numbers  ICMJE 2125-MEL-301
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Responsible Party Idera Pharmaceuticals, Inc.
Study Sponsor  ICMJE Idera Pharmaceuticals, Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Idera Medical Director Idera Pharmaceuticals, Inc.
PRS Account Idera Pharmaceuticals, Inc.
Verification Date October 2019

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