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

Primary Purpose

Metastatic Melanoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Tilsotolimod with Ipilimumab
Sponsored by
Idera Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Melanoma, PD1, PD-1, refractory, metastatic, IMO-2125, illuminate 301, TLR9 agonist, advanced melanoma, CTLA4, CTLA-4, immunotherapy, skin cancer, ILLUMINATE-301

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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)-α 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.

Sites / Locations

  • University of Alabama at Birmingham (UAB)
  • Banner MD Anderson Cancer Center
  • Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center
  • University of Southern California
  • University of California, Los Angeles (UCLA)
  • Sutter Health Sacramento
  • University of California, San Diego (UCSD) - Moores Cancer Center
  • Stanford Cancer Center
  • Mount Sinai Medical Center of Florida, Inc.
  • University of Florida Health Cancer Center - Orlando Health
  • The Valley Hospital
  • University of Cincinnati Health
  • The Cleveland Clinic Foundation
  • The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
  • MD Anderson Cancer Center
  • Inova Health Care Services
  • Greenslopes Private Hospital
  • Icon Cancer Center
  • Gold Coast University Hospital
  • Queen Elizabeth Hospital
  • University Hospital Geelong
  • Fiona Stanley Hospital
  • Tom Baker Cancer Centre
  • Alberta Health Services Cross Cancer Institute
  • Princess Margaret Hopsital
  • Fakultni nemocnice Olomouc - Oncology clinic
  • Dermatovenerologika Klinika
  • Vseobecna fakultni nemocnice v Praze
  • CHU - Clermont Ferrand
  • CHRU Besançon - Jean Minjoz
  • CHU Amiens Picardie - Hopital Sud
  • CHU Dijon - Hôpital Mitterrand
  • CHU de Grenoble
  • CHRU de Lille - Hôpital Claude Huriez
  • Centre Leon Berard
  • CHU de Marseille - Hopital de la Timone
  • Hopital Saint Louis
  • Centre Hospitalier Lyon Sud
  • CHU Hopitaux de Rouen
  • Institut Gustave Roussy
  • Klinikum Augsburg
  • Charite Universitaetsmedizin Berlin
  • Elbe Kliniken
  • Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie
  • Universitaetsklinikum Heidelberg Universitaets-Hautklinik
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Universitatsklinikum Regensburg
  • Universität Tübingen
  • Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg
  • Azienda Ospedale Policlinico di Bari
  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
  • ASST degli Spedali Civili di Brescia
  • IRCCS Azienda Ospedaliera Universitaria San Martino IST
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Istituto Europeo di Oncologia
  • Azienda Ospedaliero-Universitaria di Modena
  • Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale"
  • Istituto Oncologico Veneto-I.R.C.C.S.
  • Azienda Ospedaliero Universitaria Pisana
  • Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
  • Azienda Ospedaliero Universitaria Senese
  • Universita di Torino
  • Leids Universitair Medisch Centrum
  • Universitair Medisch Centrum Utrecht
  • Hospital Universitario A Coruna
  • Hospital Germans Trias i Pujol
  • Hospital Universitari Quiron Dexeus Barcelona
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic Barcelona
  • Onkologikoa
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Virgen Macarena
  • Consorci Hospital General Universitari de Valencia
  • Skånes Universitetssjukhus i Lund
  • Karolinska Universitetssjukhuset
  • Centrallasarettet i Växjö
  • Bristol Haematology and Oncology Centre
  • Guy's Hospital
  • Royal Marsden Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: ipilimumab

Arm B: IMO-2125 plus ipilimumab

Arm Description

ipilimumab 3 mg/kg intravenous

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 13, 2018
Last Updated
October 17, 2022
Sponsor
Idera Pharmaceuticals, Inc.
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03445533
Brief Title
A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
Official Title
A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of Efficacy
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, PD1, PD-1, refractory, metastatic, IMO-2125, illuminate 301, TLR9 agonist, advanced melanoma, CTLA4, CTLA-4, immunotherapy, skin cancer, ILLUMINATE-301

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
481 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: ipilimumab
Arm Type
Experimental
Arm Description
ipilimumab 3 mg/kg intravenous
Arm Title
Arm B: IMO-2125 plus ipilimumab
Arm Type
Experimental
Arm Description
IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy®
Intervention Description
Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
Intervention Type
Drug
Intervention Name(s)
Tilsotolimod with Ipilimumab
Other Intervention Name(s)
IMO-2125 with Yervoy
Intervention Description
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
Primary Outcome Measure Information:
Title
Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1
Description
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.
Time Frame
Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).
Title
Summary of Overall Survival
Description
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.
Time Frame
OS is measured from the date of randomization to the date of death from any cause (up to 36 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must be willing and able to sign the informed consent and comply with the study protocol. Subjects must be ≥18 years of age. 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. 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: 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). 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. If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method. 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. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. Patients must meet the following laboratory criteria: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/mm3) Platelet count ≥ 75 x 10^9/L (75,000/mm3) Hemoglobin ≥ 8.0 g/dL (4.96 mmol/L) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/minute Aspartate aminotransferase (AST) ≤ 2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; AST/ALT < 5 x ULN if liver involvement Serum bilirubin ≤ 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL 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. WOCBP must have a negative pregnancy test (serum or urine). Exclusion Criteria: Ocular melanoma. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents. Prior ipilimumab treatment with the exception of adjuvant treatment completed ≥6 months prior to enrollment Systemic treatment with interferon (IFN)-α within the previous 6 months. Known hypersensitivity to any oligodeoxynucleotide. Active autoimmune disease requiring disease-modifying therapy at the time of Screening. Subjects requiring systemic steroid therapy receiving >10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study. 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). Active systemic infections requiring antibiotics Active hepatitis A, B, or C infection. Known diagnosis of human immunodeficiency virus (HIV) infection. Women who are pregnant or breastfeeding. Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures. 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 Impaired cardiac function or clinically significant cardiac disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idera Medical Director
Organizational Affiliation
Idera Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sutter Health Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California, San Diego (UCSD) - Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Mount Sinai Medical Center of Florida, Inc.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Florida Health Cancer Center - Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
University of Cincinnati Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Health Care Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Icon Cancer Center
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Alberta Health Services Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Hopsital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Fakultni nemocnice Olomouc - Oncology clinic
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Dermatovenerologika Klinika
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha
ZIP/Postal Code
10034
Country
Czechia
Facility Name
CHU - Clermont Ferrand
City
Clermont-Ferrand
State/Province
Cedex
ZIP/Postal Code
63003
Country
France
Facility Name
CHRU Besançon - Jean Minjoz
City
Rouen
State/Province
Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Amiens Picardie - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Dijon - Hôpital Mitterrand
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
CHRU de Lille - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
CHU de Marseille - Hopital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Hopitaux de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Elbe Kliniken
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie
City
Hannöver
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg Universitaets-Hautklinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universität Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Azienda Ospedale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera Universitaria San Martino IST
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto-I.R.C.C.S.
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Universita di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Hospital Universitario A Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Quiron Dexeus Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Onkologikoa
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Consorci Hospital General Universitari de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Skånes Universitetssjukhus i Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Solna
ZIP/Postal Code
17164
Country
Sweden
Facility Name
Centrallasarettet i Växjö
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://ideraclinicaltrials.com/tilsotolimod-clinical-trials/illuminate-301/
Description
for more information

Learn more about this trial

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

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