- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644967
A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85719
- The University of Arizona Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center Research Institute
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Westwood, Kansas, United States, 66205
- University of Kansas Cancer Center
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah- Huntsman Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically confirmed metastatic melanoma with measurable, stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease.
Patients must have symptomatic or radiographic progression during or after treatment with a PD-(L)1 inhibitor administered either as monotherapy or in combination.
- The interval between last PD-(L)1 directed treatment and start of study treatment should be at least 21 days.
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.
- Prior ipilimumab is permitted.
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.
- 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.
- Patients must be ≥ 18 years of age.
- 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 10^9/L (1500/mm3)
- Platelet count ≥ 75 x 10^9/L (75,000/mm3)
- Hemoglobin ≥ 8.0 g/dL (4.96 mmol/L)
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/minute
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; AST/ALT < 5 x ULN if liver involvement
- Serum bilirubin ≤ 1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
- 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.
- Patients must have an anticipated life expectancy > 3 months.
Exclusion Criteria:
- 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.
- Patients who have received systemic treatment with IFN-α within the previous 6 months prior to enrolling into this study.
- Patients with known hypersensitivity to any oligodeoxynucleotide.
- Patients with active autoimmune disease requiring disease-modifying therapy.
- Patients requiring concurrent systemic steroid therapy higher than physiologic dose (7.5 mg/day of prednisone).
- Patients with any form of active primary or secondary immunodeficiency.
- Patients with another primary malignancy that has not been in remission for at least 3 years.
- Patients with active systemic infections requiring antibiotics or active hepatitis A, B, or C.
- Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patients who previously had a severe reaction to treatment with a human antibody.
- Patients with known central nervous system, meningeal, or epidural disease.
- Women who are pregnant or breastfeeding.
- Patients with impaired cardiac function or clinically significant cardiac disease.
- Patients with ocular melanoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 2, 8 mg Tilso/Ipi
IMO-2125 intratumoral injection plus ipilimumab
|
Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.
Other Names:
4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1
Time Frame: 33 weeks (29 weeks of treatment, 4 weeks follow up)
|
The following combined analysis populations were used for outcome measures (efficacy analysis N=53):
The ORR for 49 evaluable (4 non-evaluable) participants who received the recommended Phase 2 dose (RP2D) of 8 mg Tilso/Ipi was calculated using the participant's best overall response (BOR). Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - >=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum of diameters of target lesions. Overall Response = CR or PR |
33 weeks (29 weeks of treatment, 4 weeks follow up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 2: Progression-free Survival
Time Frame: 33 weeks (29 weeks of treatment, 4 weeks follow up)
|
The following combined analysis populations were used for outcome measures (efficacy analysis N=53):
Progression-free survival was defined as the number of months from the initiation of treatment to confirmed disease progression using RECIST v1.1 or death from any cause. |
33 weeks (29 weeks of treatment, 4 weeks follow up)
|
Phase 2: Overall Survival - 6 Months
Time Frame: 6 months
|
The following combined analysis populations were used for outcome measures (efficacy analysis N=53):
Overall survival was defined as the number of months from initiation of treatment to death from any cause. |
6 months
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Phase 2: Overall Survival - 12 Months
Time Frame: 12 months
|
The following combined analysis populations were used for outcome measures (efficacy analysis N=53):
Overall survival was defined as the number of months from initiation of treatment to death from any cause. |
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
Other Study ID Numbers
- 2125-204
- ILLUMINATE-204 (Other Identifier: Idera Pharmaceuticals, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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