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

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Hematinics

Pembrolizumab

Nivolumab

Liver Extracts

Three weekly doses of SD-101 given over two cycles via HAI using the PEDD method of administration.

SD-101 doses will be delivered via HAI using the PEDD method of administration.

SD-101

During Phase 1b, Cohort B, pembrolizumab will be administered together with SD-101.

During Phase 1b, Cohort C, nivolumab will be administered together with ipilimumab and SD-101.

During Phase 1b, Cohort C, ipilimumab will be administered together with nivolumab and SD-101.

This is an Open-label, Phase 1b/2 Study of the Pressure-Enabled Hepatic Artery Infusion (HAI) of SD-101, a TLR9 agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC).

All patients will receive 2 cycles of SD-101. Each cycle consists of 3 consecutive weekly infusions and Cycles 1 and 2 are separated by one month. Escalating doses of SD-101 will be administered alone (Cohort A), together with pembrolizumab (Cohort B), and together with combined ipilimumab and nivolumab (Cohort C). Cohort B will begin dosing at the minimum anticipated biological effect level (MABEL (2mg SD-101)). Cohort C will begin one dose level below the MTD or optimal dose from Cohort B to optimize safety when adding CPI to SD-101.

Following determination of the recommended MTD or optimal dose of SD-101 and which checkpoint inhibitor (CPI) regimen(s) are tolerated, the study will progress to Phase 2. Patients in Phase 2 will receive the SD-101 dose selected from Phase 1b together with systemic single- or double-agent checkpoint blockade. The choice of single- or double-agent CPI therapy together with SD-101 for Phase 2 will consider safety data in addition to response rates from Cohorts B and C in Phase 1b.

Phase 1b: Escalating doses of SD-101 will be administered alone (Cohort A), together with pembrolizumab (Cohort B), or together with combined ipilimumab and nivolumab. Three weekly doses of SD-101 are delivered over two cycles via HAI using the Pressure Enabled Drug Delivery (PEDD) method of administration.

Phase 2: Three weekly infusions of SD-101 will be delivered via PEDD/HAI over two cycles at the dose selected from Phase 1b in combination with systemic single- or dual-agent checkpoint blockade.

Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

A Phase 1b/2 Pressure Enabled Regional Immuno-Oncology Study of Hepatic Arterial Infusion of SD-101 With Systemic Checkpoint Blockade for Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma

As a measure of safety, adverse events will be graded according to CTCAE v5.0.

A standard 3+3 dose-escalation design will be employed to determine the MTD or optimal dose.

As a measure of activity, ORR will be assessed. ORR will be assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

As a measure of activity, iRECIST will be utilized to determine ORR.

As a measure of activity, mRECIST will be utilized to determine ORR.

As a measure of activity, RECIST 1.1 will be utilized to determine hepatic-specific response rate (HRR).

As a measure of activity, RECIST 1.1 will be utilized to determine overall progression-free survival (PFS).

As a measure of activity, RECIST 1.1 will be utilized to determine clinical benefit (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]).

As a measure of activity, RECIST 1.1 will be utilized to determine duration of response (DOR).

As a measure of activity, OS will be assessed. The events for the assessment of 12-month OS are death events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma	NCT03445533	Metastatic Mela...	Ipilimumab Tilsotolimod wi...	18 Years -	Idera Pharmaceuticals, Inc.
Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors	NCT05220722	Hepatocellular ... Intrahepatic Ch...	SD-101 Pembrolizumab Nivolumab Ipilimumab	18 Years - 99 Years	TriSalus Life Sciences, Inc.
Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors	NCT05220722	Hepatocellular ... Intrahepatic Ch...	SD-101 Pembrolizumab Nivolumab Ipilimumab	18 Years - 99 Years	TriSalus Life Sciences, Inc.

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