Metastatic Melanoma Clinical Trial
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)
Verified date | October 2022 |
Source | Idera Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Status | Terminated |
Enrollment | 481 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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)-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. |
Country | Name | City | State |
---|---|---|---|
Australia | University Hospital Geelong | Geelong | Victoria |
Australia | Greenslopes Private Hospital | Greenslopes | Queensland |
Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
Australia | Icon Cancer Center | South Brisbane | Queensland |
Australia | Gold Coast University Hospital | Southport | Queensland |
Australia | Queen Elizabeth Hospital | Woodville South | South Australia |
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Alberta Health Services Cross Cancer Institute | Edmonton | Alberta |
Canada | Princess Margaret Hopsital | Toronto | Ontario |
Czechia | Fakultni nemocnice Olomouc - Oncology clinic | Olomouc | |
Czechia | Dermatovenerologika Klinika | Praha | |
Czechia | Vseobecna fakultni nemocnice v Praze | Praha | |
France | CHU Amiens Picardie - Hopital Sud | Amiens | |
France | CHU - Clermont Ferrand | Clermont-Ferrand | Cedex |
France | CHU Dijon - Hôpital Mitterrand | Dijon | |
France | CHU de Grenoble | La Tronche | |
France | CHRU de Lille - Hôpital Claude Huriez | Lille | |
France | Centre Leon Berard | Lyon Cedex 08 | |
France | CHU de Marseille - Hopital de la Timone | Marseille | |
France | Hopital Saint Louis | Paris | |
France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
France | CHRU Besançon - Jean Minjoz | Rouen | Cedex |
France | CHU Hopitaux de Rouen | Rouen | |
France | Institut Gustave Roussy | Villejuif | |
Germany | Klinikum Augsburg | Augsburg | |
Germany | Charite Universitaetsmedizin Berlin | Berlin | |
Germany | Elbe Kliniken | Buxtehude | |
Germany | Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie | Hannöver | |
Germany | Universitaetsklinikum Heidelberg Universitaets-Hautklinik | Heidelberg | |
Germany | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | |
Germany | Universitatsklinikum Regensburg | Regensburg | |
Germany | Universität Tübingen | Tübingen | |
Germany | Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg | Würzburg | |
Italy | Azienda Ospedale Policlinico di Bari | Bari | |
Italy | Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari | Bari | |
Italy | ASST degli Spedali Civili di Brescia | Brescia | |
Italy | IRCCS Azienda Ospedaliera Universitaria San Martino IST | Genova | |
Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | |
Italy | Istituto Europeo di Oncologia | Milano | |
Italy | Azienda Ospedaliero-Universitaria di Modena | Modena | |
Italy | Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale" | Napoli | |
Italy | Istituto Oncologico Veneto-I.R.C.C.S. | Padova | |
Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
Italy | Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | |
Italy | Azienda Ospedaliero Universitaria Senese | Siena | |
Italy | Universita di Torino | Torino | |
Netherlands | Leids Universitair Medisch Centrum | Leiden | |
Netherlands | Universitair Medisch Centrum Utrecht | Utrecht | |
Spain | Hospital Universitario A Coruna | A Coruña | |
Spain | Hospital Germans Trias i Pujol | Badalona | |
Spain | Hospital Clinic Barcelona | Barcelona | |
Spain | Hospital Universitari Quiron Dexeus Barcelona | Barcelona | |
Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
Spain | Onkologikoa | Donostia | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Universitario Ramon y Cajal | Madrid | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Spain | Consorci Hospital General Universitari de Valencia | Valencia | |
Sweden | Skånes Universitetssjukhus i Lund | Lund | |
Sweden | Karolinska Universitetssjukhuset | Solna | |
Sweden | Centrallasarettet i Växjö | Växjö | |
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
United Kingdom | Guy's Hospital | London | |
United Kingdom | Royal Marsden Foundation Trust | London | |
United States | University of Alabama at Birmingham (UAB) | Birmingham | Alabama |
United States | University of Cincinnati Health | Cincinnati | Ohio |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) | Columbus | Ohio |
United States | Inova Health Care Services | Falls Church | Virginia |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of California, Los Angeles (UCLA) | Los Angeles | California |
United States | University of Southern California | Los Angeles | California |
United States | Mount Sinai Medical Center of Florida, Inc. | Miami Beach | Florida |
United States | University of Florida Health Cancer Center - Orlando Health | Orlando | Florida |
United States | The Valley Hospital | Ridgewood | New Jersey |
United States | Sutter Health Sacramento | Sacramento | California |
United States | University of California, San Diego (UCSD) - Moores Cancer Center | San Diego | California |
United States | Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center | Scottsdale | Arizona |
United States | Stanford Cancer Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Idera Pharmaceuticals, Inc. | Bristol-Myers Squibb |
United States, Australia, Canada, Czechia, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months). | |
Primary | 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. | OS is measured from the date of randomization to the date of death from any cause (up to 36 months). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02224781 -
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
Recruiting |
NCT05388877 -
E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
|
Phase 1 | |
Active, not recruiting |
NCT05103891 -
Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations
|
Phase 1 | |
Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
Completed |
NCT01621490 -
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
|
Phase 1 | |
Recruiting |
NCT05779423 -
Cryoablation+Ipilimumab+Nivolumab in Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT02278887 -
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT02360579 -
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
|
Phase 2 | |
Terminated |
NCT02521870 -
A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT02177110 -
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
|
||
Withdrawn |
NCT01340729 -
Open-Label Study of TPI 287 for Patients With Metastatic Melanoma
|
Phase 1/Phase 2 | |
Withdrawn |
NCT01416844 -
Study of Immune Responses in Patients With Metastatic Melanoma
|
Phase 2 | |
Terminated |
NCT01468818 -
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00984464 -
Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00631618 -
Clinical Trial of Sutent to Treat Metastatic Melanoma
|
Phase 2 | |
Terminated |
NCT00571116 -
Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy
|
Phase 1 | |
Recruiting |
NCT00226473 -
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
|
Phase 4 |