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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03445533




Registration number
NCT03445533
Ethics application status
Date submitted
13/02/2018
Date registered
26/02/2018

Titles & IDs
Public title
A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
Scientific title
A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Secondary ID [1] 0 0
2125-MEL-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Tilsotolimod with Ipilimumab

Experimental: Arm A: ipilimumab - ipilimumab 3 mg/kg intravenous

Experimental: Arm B: IMO-2125 plus ipilimumab - IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous


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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1
Timepoint [1] 0 0
Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).
Primary outcome [2] 0 0
Summary of Overall Survival
Timepoint [2] 0 0
OS is measured from the date of randomization to the date of death from any cause (up to 36 months).

Eligibility
Key inclusion criteria
1. Subjects must be willing and able to sign the informed consent and comply with the study protocol.
2. Subjects must be =18 years of age.
3. Subjects must have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.
4. Patients must have confirmed progression during or after treatment with a PD-1 inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab. Confirmed progression is defined as:

* Radiological progression (confirmed at least 4 weeks after the initial scan showing PD); or
* (For progression based solely on worsening of non-target or new, non-measurable disease) confirmation by an additional scan at least 4 weeks after the initial scan unless it is accompanied by correlative symptoms.

In addition, all the following must hold:
1. No intervening anti-cancer therapy between the last course of PD-1 inhibitor treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
2. The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
3. If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.
4. Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy.
5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
6. Patients must meet the following laboratory criteria:

1. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1500/mm3)
2. Platelet count = 75 x 10^9/L (75,000/mm3)
3. Hemoglobin = 8.0 g/dL (4.96 mmol/L)
4. Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated creatinine clearance = 60 mL/minute
5. Aspartate aminotransferase (AST) = 2.5 x ULN; alanine aminotransferase (ALT) = 2.5 x ULN; AST/ALT < 5 x ULN if liver involvement
6. Serum bilirubin = 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
7. 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 either ipilimumab or IMO-2125, whichever is later.
8. WOCBP must have a negative pregnancy test (serum or urine).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ocular melanoma.
2. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.
3. Prior ipilimumab treatment with the exception of adjuvant treatment completed =6 months prior to enrollment
4. Systemic treatment with interferon (IFN)-a within the previous 6 months.
5. Known hypersensitivity to any oligodeoxynucleotide.
6. Active autoimmune disease requiring disease-modifying therapy at the time of Screening.
7. Subjects requiring systemic steroid therapy receiving >10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study.
8. Subjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of 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).
9. Active systemic infections requiring antibiotics
10. Active hepatitis A, B, or C infection.
11. Known diagnosis of human immunodeficiency virus (HIV) infection.
12. Women who are pregnant or breastfeeding.
13. Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures.
14. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for =4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone =10 mg/day or equivalent
15. Impaired cardiac function or clinically significant cardiac disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2021
Sample size
Target
Accrual to date
Final
481
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [2] 0 0
Icon Cancer Center - South Brisbane
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
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United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Czechia
State/province [11] 0 0
Olomouc
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha
Country [13] 0 0
France
State/province [13] 0 0
Cedex
Country [14] 0 0
France
State/province [14] 0 0
Amiens
Country [15] 0 0
France
State/province [15] 0 0
Dijon
Country [16] 0 0
France
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La Tronche
Country [17] 0 0
France
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Lille
Country [18] 0 0
France
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Lyon Cedex 08
Country [19] 0 0
France
State/province [19] 0 0
Marseille
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Pierre-Bénite
Country [22] 0 0
France
State/province [22] 0 0
Rouen
Country [23] 0 0
France
State/province [23] 0 0
Villejuif
Country [24] 0 0
Germany
State/province [24] 0 0
Augsburg
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
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Germany
State/province [26] 0 0
Buxtehude
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Germany
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Hannöver
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Germany
State/province [28] 0 0
Heidelberg
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Germany
State/province [29] 0 0
Mainz
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Germany
State/province [30] 0 0
Regensburg
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Germany
State/province [31] 0 0
Tübingen
Country [32] 0 0
Germany
State/province [32] 0 0
Würzburg
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Italy
State/province [33] 0 0
Bari
Country [34] 0 0
Italy
State/province [34] 0 0
Brescia
Country [35] 0 0
Italy
State/province [35] 0 0
Genova
Country [36] 0 0
Italy
State/province [36] 0 0
Meldola
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
State/province [41] 0 0
Pisa
Country [42] 0 0
Italy
State/province [42] 0 0
Rome
Country [43] 0 0
Italy
State/province [43] 0 0
Siena
Country [44] 0 0
Italy
State/province [44] 0 0
Torino
Country [45] 0 0
Netherlands
State/province [45] 0 0
Leiden
Country [46] 0 0
Netherlands
State/province [46] 0 0
Utrecht
Country [47] 0 0
Spain
State/province [47] 0 0
A Coruña
Country [48] 0 0
Spain
State/province [48] 0 0
Badalona
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Donostia
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Sweden
State/province [54] 0 0
Lund
Country [55] 0 0
Sweden
State/province [55] 0 0
Solna
Country [56] 0 0
Sweden
State/province [56] 0 0
Växjö
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Bristol
Country [58] 0 0
United Kingdom
State/province [58] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Idera Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Idera Medical Director
Address 0 0
Idera Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03445533