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A Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma (ILLUMINATE-204)

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ClinicalTrials.gov Identifier: NCT02644967
Recruitment Status : Active, not recruiting
First Posted : January 1, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 23, 2015
First Posted Date  ICMJE January 1, 2016
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • Phase 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 to determine the recommended Phase 2 dose of IMO-2125. [ Time Frame: 33 weeks (29 weeks of treatment, 4 weeks follow up ]
  • Phase 2: Number of participants with objective response using RECIST v1.1 [ Time Frame: 33 weeks (29 weeks of treatment, 4 weeks follow up ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 31, 2015)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 17 weeks (13 weeks of treatment + 4 weeks follow up) ]
  • Number of participants with objective response utilizing the immune-related response criteria (irRC). [ Time Frame: 17 weeks (13 weeks of treatment + 4 weeks follow up) ]
Change History Complete list of historical versions of study NCT02644967 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 to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma
Official Title  ICMJE A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma ILLUMINATE-204)
Brief Summary The goal of this clinical research study is to find the recommended dose of the study drug IMO-2125 that can be given in combination with ipilimumab or in combination with pembrolizumab to patients with metastatic melanoma. Researchers also want to learn if the study drug combination can help to control the disease. The safety of the drug combination will also be studied.
Detailed Description This is an open-label Phase 1/2 study to determine the recommended dose and assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of IMO-2125 when administered in combination with ipilimumab or pembrolizumab. The study will be conducted in 2 parts; a dose-escalation portion (Phase 1) to evaluate safety and tolerability of multiple dose levels and a Phase 2 portion to assess efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE
  • Drug: IMO-2125
    Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.
  • Drug: Ipilimumab
    4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
    Other Name: Yervoy®
  • Drug: Pembrolizumab
    Drug: Pembrolizumab Administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks beginning on Week 2.
    Other Name: Keytruda®
Study Arms  ICMJE
  • Experimental: Arm 1
    IMO-2125 intratumoral injection plus ipilimumab
    Interventions:
    • Drug: IMO-2125
    • Drug: Ipilimumab
  • Experimental: Arm 2
    IMO-2125 intratumoral injection plus pembrolizumab
    Interventions:
    • Drug: IMO-2125
    • Drug: Pembrolizumab
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
53
Original Estimated Enrollment  ICMJE
 (submitted: December 31, 2015)
42
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must have histologically confirmed metastatic melanoma with measurable, stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease.
  2. Patients must have symptomatic or radiographic progression during or after treatment with a PD-(L)1 inhibitor administered either as monotherapy or in combination.

    1. The interval between last PD-(L)1 directed treatment and start of study treatment should be at least 21 days.
    2. Prior BRAF or MEK inhibitor treatment is not required. However, for patients with known BRAF status:

      • Those with BRAF wild type may have had a maximum of two previous systemic regimens for the treatment of melanoma.
      • Those with a BRAF mutation may have had a maximum of three previous systemic regimens for the treatment of melanoma.
    3. Prior ipilimumab is permitted.
    4. Previous treatment with either a PD-1 inhibitor (for patients enrolling on the IMO-2125 + pembrolizumab combination) or CTLA-4 inhibitor (for patients enrolling on the IMO-2125 + ipilimumab combination if applicable) should not have been accompanied by DLT for which permanent discontinuation is recommended (per USPI).

      • Patients with a history of Grade ≥2 gastrointestinal symptoms (e.g., diarrhea, colitis) during prior checkpoint inhibitor treatment should be discussed with the Idera Medical Monitor during the Screening Period before starting study treatment.
  3. Phase 1 patients must have at least two measurable tumor lesions ≥ 1.0 cm that are accessible to biopsy. Phase 2 patients must have at least one measurable lesion (per RECIST v1.1) which may be the same site that is used for the intratumoral injections.
  4. Patients must be ≥ 18 years of age.
  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 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 patients 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 IMO-2125, 3 months after the last dose of ipilimumab or at least 4 months after the last dose of pembrolizumab.
  8. Patients must have an anticipated life expectancy > 3 months.

Exclusion Criteria:

  1. Patients who have received prior therapy with a TLR agonist, excluding topical agents. Patients who have received experimental vaccines or other investigational immune therapies should be discussed with the Medical Monitor to confirm eligibility.
  2. Patients who have received systemic treatment with IFN-α within the previous 6 months prior to enrolling into this study.
  3. Patients with known hypersensitivity to any oligodeoxynucleotide.
  4. Patients with active autoimmune disease requiring disease-modifying therapy.
  5. Patients requiring concurrent systemic steroid therapy higher than physiologic dose (7.5 mg/day of prednisone).
  6. Patients with any form of active primary or secondary immunodeficiency.
  7. Patients with another primary malignancy that has not been in remission for at least 3 years.
  8. Patients with active systemic infections requiring antibiotics or active hepatitis A, B, or C.
  9. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
  10. Patients who previously had a severe reaction to treatment with a human antibody.
  11. Patients with known central nervous system, meningeal, or epidural disease.
  12. Women who are pregnant or breastfeeding.
  13. Patients with impaired cardiac function or clinically significant cardiac disease.
  14. Patients with ocular melanoma.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02644967
Other Study ID Numbers  ICMJE 2125-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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 October 2018

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