Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Vitamins

Pembrolizumab

Leucovorin

Levoleucovorin

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Folinic Acid

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.

IMO-2125

4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Idera Medical Director

The goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when administered in combination with ipilimumab or pembrolizumab.

The open-label single-arm Phase 2 study was designed to assess the recommended dose for safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of 8 mg IMO-2125 (tilsotolimod) when administered in combination with ipilimumab.

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)

The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

* The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population (N=44)
* The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

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

The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

* The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable)
* The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

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.

The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

* The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=44 (40 with 4 non-evaluable)
* The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

Overall survival was defined as the number of months from initiation of treatment to death from any cause.

The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

* The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable)
* The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

Overall survival was defined as the number of months from initiation of treatment to death from any cause.

Idera Pharmaceuticals, Inc.

Definitions aligned with FDA and ICH requirements.

Arm/Group includes 9 participants rolled over from Phase 1, 8 mg Tilso/Ipi.

IMO-2125 intratumoral injection plus ipilimumab

IMO-2125: Drug: IMO-2125 (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.

Ipilimumab: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Phase 2, 8 mg Tilso/Ipi

IMO-2125 intratumoral injection plus ipilimumab

IMO-2125: Drug: IMO-2125 (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.

Ipilimumab: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index

Baseline Melanoma Characteristics

Physician assessed and determined based on American Joint Committee on Cancer (AJCC) Staging System for Melanoma, Seventh Edition, which determines the stage (I-V) based on the TNM classification. T refers to tumor size, N refers to nearby lymph nodes and M represents metastasized (spread) to other parts of the body. This staging number is obtained as a sum of the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis for the patient.

Baseline Melanoma Stage

Baseline Brain Metastases

Baseline Visceral Metastases

Baseline Elevated LDH

Baseline BRAF Mutation

Therapeutic Lymph Node Dissection

Radiation

Chemotherapy

Interferon

BRAF Inhibitor

MEK Inhibitor

CTLA-4 Inhibitor

PD-(L)1 Inhibitor

Other

Indicates multiple, known prior melanoma treatments. Participants may be counted in more than one category based on combination of prior melanoma treatments.

Prior Melanoma Treatment

Includes all participants who received at least 1 dose of study treatment.

The analysis populations, as defined in section 6 of the Statistical Analysis Plan, analyzed participants enrolled in the phase 2 study (N=44) and participants rolled in from the phase 1, 8 mg Tilso/Ipi population (N=9).

Head of Clinical Operations

Testing the best overall confirmed response rate against the historical control rate of 0.11 (extracted from the literature review).

Arm/Group includes 9 participants rolled over from Phase 1 8mg Tilso/Ipi

IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi)

IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.

Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Per the SAP, section 6, Analysis Populations used for efficacy, the analysis populations utilize both PIIEE (Primary Ipilimumab + IMO-2125 Efficacy Evaluable) who are ipilimumab-naive and SIIEE (Secondary Ipilumumab + IMO-2125 Efficacy Evaluable) who are not ipilumumab-naive that were treated at the RP2D, regardless of phase, and received at least one dose of each study drug.

Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1

Phase 2: Progression-free Survival

Phase 2: Overall Survival - 6 Months

Phase 2: Overall Survival - 12 Months

IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi)

IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.

Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Spots Global Cancer Trial Database for A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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