Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Skin Neoplasms

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 Diseases

Neuroendocrine Tumor

Neuroepithelioma

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Leucovorin

Levoleucovorin

Immunomodulating Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Folinic Acid

IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous

Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.

IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod

Tilsotolimod with Ipilimumab

Idera Medical Director

A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

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

A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma

A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)

The ORR for evaluable participants 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.

The calculation is derived from measuring the diameter (mm) of the target lesion at baseline and comparing target lesion diameter (mm) at intervals during treatment and/or post-treatment. Based on the percent of tumor decrease or increase, the appropriate category is assigned.

Efficacy measured by overall survival (OS) was defined as the number of participants alive compared to the number of participants that died by treatment group.

Bristol-Myers Squibb

Idera Pharmaceuticals, Inc.

Definitions aligned with FDA and ICH requirements.

The grading of adverse events utilized the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03, which were defined as:

Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death

ipilimumab 3 mg/kg intravenous

ipilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.

Arm A: Ipilimumab

IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous

Tilsotolimod with ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod.

Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab

ipilimumab 3 mg/kg intravenous

Ipilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.

IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous

Tilsotolimod with Ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod

Arm B: IMO-2125 Plus Ipilimumab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

Netherlands

Sweden

United States

Czechia

Italy

United Kingdom

Australia

France

Germany

Spain

Region of Enrollment

Baseline Melanoma Characteristics

Measure Description: 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 Staging

Baseline Elevated LDH (lactate dehydrogenase)

The Eastern Cooperative Oncology Group (ECOG) Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scale grades are from 0 (fully active) best to 5 (dead) worst and are determined by physician assessment of the patient.

Grade:

0 - Fully active

1. - Restricted in physically strenuous activity
2. - Ambulatory, but unable to work
3. - Limited selfcare, confined to bed/chair \> 50% of waking hours
4. - Completely disabled, confined to bed/chair, no selfcare
5. - Dead

ECOG Performance Status

PD-1 Inhibitor

BRAK Inhibitor

MEK Inhibitor

Other

Other Immunotherapy

Cytokine

Chemotherapy

CTLA-4 Inhibitor

Oncolytic Virus

Other Targeted Therapy

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

Prior Systemic Anti-cancer Treatment

Unresectable/Metastatic Disease

Adjuvant

Neoadjuvant

Prior Systemic Anti-cancer Treatment Setting

Complete Response

Partial Response

Stable Disease

Progressive Disease

Unknown

Best Response from Last Prior Systemic Anti-cancer Treatment

Duration of Prior Anti-PD-1 Therapy

BRAF Mutation Status and Prior Targeted Therapy

Head of Clinical Operations

The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.

All percentages were based on the number of participants in the Intent-to-Treat (ITT) analysis set within each group. Participants with no disease assessment in the study were included in the Not Evaluable category under Best Overall Response.

Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1

All percentages were based on the number of participants in the Intent-to-Treat (ITT) analysis set within each group.

Summary of Overall Survival

Overall Study

Spots Global Cancer Trial Database for tilsotolimod with ipilimumab