A Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)

Study Description

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Brief Summary:

This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.

Condition or disease	Intervention/treatment	Phase
Refractory Solid Tumors; Melanoma	Drug: IMO-2125	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	62 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 1b Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)
Actual Study Start Date :	June 9, 2017
Estimated Primary Completion Date :	April 2019
Estimated Study Completion Date :	April 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: IMO-2125 at escalating dose levels; IMO-2125 at escalating dose levels by intratumoral injection	Drug: IMO-2125; IMO-2125 will be administered by intratumoral injection on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle.

Outcome Measures

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Primary Outcome Measures :

1. Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Number of patients with treatment-related adverse events as assessed by CTCAE to determine the recommended Phase 2 dose (RP2D). [ Time Frame: 51 weeks of treatment ]
2. Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Objective response rate [ Time Frame: Assessed every 6 weeks for duration of study participation, which is estimated to be 51 weeks ]
3. Melanoma Expansion Cohort: Objective response rate [ Time Frame: Assessed every 9 weeks for duration of study participation, which is estimated to be 51 weeks ]
4. Melanoma Expansion Cohort: Number of patients with treatment-related adverse events as assessed by CTCAE [ Time Frame: 51 weeks of treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.

2. Patients who have a diagnosis for which a PD-(L)-1 inhibitor has been approved must have previously received treatment with one of these therapies.

   a. Melanoma Dose Expansion: Patients must have histologically confirmed metastatic melanoma (ocular melanoma not included) which has progressed on or after treatment with a PD-(L)1 inhibitor.

3. a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy.

   b) Melanoma Expansion Cohort: Patients must have at least one target lesion by Response Evaluation Criteria for Solid Tumors (RECIST v1.1), with at least one lesion accessible for intratumoral injection. Tumor biopsies are not required in the expansion cohort.

4. Patients must be 18 years of age or older.
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 109/L (≥1500/mm3)
   2. Platelet count ≥75 x 109/L (≥75,000/mm3)
   3. Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)
   4. Serum creatinine ≤1.5 x ULN or calculated 24-hour creatinine clearance ≥60 mL/minute
   5. Aspartate aminotransferase (AST) ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement
   6. Total bilirubin ≤1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 μmol/L)
7. Women of childbearing potential and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 4 weeks after the last dose of study drug.
8. Patients must be willing and able to provide signed informed consent and comply with the study protocol.

Exclusion Criteria:

1. Patients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility.

   Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).

2. Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
3. Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis; e.g. steroids.
4. Patients with active autoimmune disease requiring disease-modifying therapy.
5. Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).
6. Patients with another primary malignancy that has not been in remission for at least 3 years, unless approved by the Idera Medical Monitor. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
7. Patients with active infections requiring systemic treatment.
8. Patients who are known to be hepatitis B surface antigen positive.
9. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
10. Women who are pregnant or breastfeeding.
11. Patients with known central nervous system, meningeal, or epidural disease. Patients with stable brain metastases following definitive local treatment are eligible if steroid requirement is <10 mg/day of prednisone (or equivalent).

12. Patients with impaired cardiac function or clinically significant cardiac disease:

    1. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy
    2. Unstable angina pectoris ≤6 months prior to study participation
    3. Acute myocardial infarction ≤6 months prior to study participation
    4. Other clinically significant heart disease (i.e., Grade ≥3 hypertension, history of labile hypertension, or poor compliance with an anti-hypertensive regimen)
13. Have not recovered (to baseline or Grade ≤1) from toxicity associated with prior treatment.

Contacts and Locations

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Contacts

Contact: Idera Study Monitor	877-888-6550 ext 2	patientinfo@iderapharma.com

Locations

United States, Arizona
Scottsdale Healthcare Hospitals DBA Honor Health	Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, RN 480-323-1339 clinicaltrials@honorhealth.com
The University of Arizona Cancer Center	Recruiting
Tucson, Arizona, United States, 85724
Contact: Hani Babiker, MD
United States, California
University of California San Francisco (UCSF)	Recruiting
San Francisco, California, United States, 94143
Contact: Joy Cannon
Principal Investigator: Alain Algazi, MD
United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263
Contact: AskRPCI 800-275-7724
United States, Ohio
The Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter Anderson, PhD, MD 216-308-2706 andersp@ccf.org
United States, Pennsylvania
St. Luke's Hospital	Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Jillian Timer, RN, BSN 484-503-4156 Jillian.Timer@SLUHN.org
UPMC Hillman Cancer Center	Completed
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Abha Adat AAdat@mdanderson.org
Israel
Rambam Medical Center	Recruiting
Haifa, Israel, 3109601
Contact: Alona Michlin
Principal Investigator: Gil Bar-Sela, MD
Hadassah Medical Center	Recruiting
Jerusalem, Israel, 9112001
Contact: Hanna Steinberg
Principal Investigator: Michal Lotem, MD
Rabin Medical Center Beilinson Campus	Recruiting
Petah tikva, Israel, 49100
Contact: Simona Segal
Principal Investigator: Daniel Hendler, MD
The Ella Lemelbaum Institute for Immuno-Oncology	Recruiting
Ramat Gan, Israel, 5265601
Contact: Jacob Schachter, MD
Principal Investigator: Jacob Schachter, MD

Sponsors and Collaborators

Idera Pharmaceuticals, Inc.

Investigators

Study Director:	Idera Medical Director	Idera Pharmaceuticals, Inc.

More Information

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Responsible Party:	Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT03052205 History of Changes
Other Study ID Numbers:	2125-RST-101
First Posted:	February 14, 2017
Last Update Posted:	October 22, 2018
Last Verified:	October 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Idera Pharmaceuticals, Inc.:

ILLUMINATE-101; melanoma

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas