A Phase 3 interventional study of Ipilimumab and Tilsotolimod with Ipilimumab in Metastatic Melanoma, sponsored by Idera Pharmaceuticals, Inc.. Terminated at 80 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Idera Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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Among 156 studies testing ipilimumab in Melanoma — 22 open to participants now, 43 under way, 5 of them phase 3. Ipilimumab · Melanoma.
Among the 156 studies testing ipilimumab in Melanoma, this one is the 9th largest by enrollment of the 153 interventional ones that give a count, is one of 6 that started in 2018, is one of 13 in phase 3, and was the 109th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →22 of the 156 studies testing ipilimumab in Melanoma are open now, in 9 countries. Recruiting first, the newest first:
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
Ages 18+ · Healthy volunteers
Swiss Cancer Institute · Sites in Switzerland
Ages 18+
Melanoma and Skin Cancer Trials Limited · Sites in Australia
Ages 18+
Radboud University Medical Center · Sites in Netherlands
Ages 18+
UNC Lineberger Comprehensive Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Ipilimumab: first FDA approval 2011 (YERVOY), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, ipilimumab is given beside the treatment under test here, not tested itself. Read study by study →
156 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 104 · Phase 3 14 · Phase 4 2
First in 2001; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 481 is above the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 30 across the 153 interventional studies. Of the 102 that completed or were terminated, 56 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 156 have an industry lead sponsor. The 10 most frequent:
Idera Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Idera Pharmaceuticals, Inc. has 3 studies filed under Melanoma — fewer than ten, so there is no comparison to draw.
8 of the studies testing ipilimumab in Melanoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06712927Stanford UniversityTrial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases | 2026-11 |
| NCT07155317Emory UniversityTime-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial | 2026-12-31 |
| NCT05289193Memorial Sloan Kettering Cancer CenterCD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma | 2027-03-11 |
| NCT07422779Institute of Oncology LjubljanaImmunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia | 2027-03-31 |
| NCT03122522Memorial Sloan Kettering Cancer CenterA Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy | 2027-04 |
Add all 8 to your calendar (.ics) → With an account.
Among the 156 studies testing ipilimumab in Melanoma, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have confirmed progression during or after treatment with a inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab. Confirmed progression is defined as:
In addition, all the following must hold:
Patients must meet the following laboratory criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ipilimumab 3 mg/kg intravenous
Drug: Ipilimumab
IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous
Drug: Tilsotolimod with Ipilimumab
Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
Also known as: Yervoy®
Drug pages: Tilsotolimod · 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
Also known as: IMO-2125 with Yervoy
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.
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).
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.
Time frame: OS is measured from the date of randomization to the date of death from any cause (up to 36 months).
The global Phase 3 study was conducted at academic cancer centers across 11 countries. Participating countries included United States, Australia, Canada, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom.
| Milestone | Arm A: Ipilimumab | Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab |
|---|---|---|
| Started | 243 | 238 |
| Completed | 115 | 45 |
| Not completed | 128 | 193 |
| Withdrew: Progressive disease | 48 | 81 |
| Withdrew: Adverse event | 60 | 64 |
| Withdrew: Death | 9 | 19 |
| Withdrew: Miscellaneous | 0 | 16 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Physician decision | 1 | 3 |
| Withdrew: Sponsor decision | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Never received any study treatment | 7 | 4 |
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.
| Participants | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab |
|---|---|---|
| Complete Response | 1 | 1 |
| Partial Response | 20 | 20 |
| Stable Disease | 45 | 61 |
| Progressive Disease | 110 | 89 |
| Not Evaluable | 67 | 67 |
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.
| Participants | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab |
|---|---|---|
| Died | 166 | 165 |
| Alive (Censored) | 77 | 73 |
Collected over Adverse events were collected from the signing of informed consent, through the duration of active study treatment (10 weeks active study for participants assigned to Arm A OR 24 weeks active study for participants assigned to Arm B) and then for 90 days after the last dose of study treatment. All-Cause Mortality was assessed for up to 36 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Ipilimumab | 166/243 (68.3%) | 108/243 (44.4%) | 218/243 (89.7%) |
| Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab | 165/238 (69.3%) | 119/238 (50%) | 226/238 (95%) |
| Event | Arm A: Ipilimumab | Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab |
|---|---|---|
| ColitisGastrointestinal disorders | 13/243 | 10/238 |
| PyrexiaGeneral disorders | 8/243 | 12/238 |
| Immune-mediated EnterocolitisGastrointestinal disorders | 11/243 | 11/238 |
| DiarrhoeaGastrointestinal disorders | 9/243 | 3/238 |
| General Physical Health DeteriorationGeneral disorders | 5/243 | 6/238 |
| Immune-mediated HepatitisHepatobiliary disorders | 5/243 | 6/238 |
| HypophysitisEndocrine disorders | 6/243 | 3/238 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/243 | 5/238 |
| ErysipelasInfections and infestations | 5/243 | 2/238 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 5/243 | 0/238 |
| Event | Arm A: Ipilimumab | Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab |
|---|---|---|
| PyrexiaGeneral disorders | 28/243 | 102/238 |
| AstheniaGeneral disorders | 52/243 | 79/238 |
| ChillsGeneral disorders | 7/243 | 75/238 |
| DiarrhoeaGastrointestinal disorders | 61/243 | 70/238 |
| PruritusSkin and subcutaneous tissue disorders | 60/243 | 57/238 |
| NauseaGastrointestinal disorders | 48/243 | 54/238 |
| FatigueGeneral disorders | 35/243 | 48/238 |
| Decreased AppetiteMetabolism and nutrition disorders | 42/243 | 45/238 |
| HeadacheNervous system disorders | 15/243 | 43/238 |
| AnaemiaBlood and lymphatic system disorders | 31/243 | 37/238 |
| Age, Continuous(years) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| Mean | 64.3 ± 13.73 | 64.3 ± 13.28 | 64.3 ± 13.49 |
| Sex: Female, Male(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| Female | 116 | 105 | 221 |
| Male | 127 | 133 | 260 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 11 |
| Not Hispanic or Latino | 211 | 187 | 398 |
| Unknown or Not Reported | 27 | 45 | 72 |
| Race (NIH/OMB)(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 6 | 1 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 2 | 2 | 4 |
| White | 207 | 187 | 394 |
| More than one race | 0 | 3 | 3 |
| Unknown or Not Reported | 27 | 44 | 71 |
| Region of Enrollment(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| Canada | 9 | 11 | 20 |
| Netherlands | 9 | 2 | 11 |
| Sweden | 2 | 3 | 5 |
| United States | 23 | 23 | 46 |
| Czechia | 11 | 19 | 30 |
| Italy | 53 | 40 | 93 |
| United Kingdom | 2 | 3 | 5 |
| Australia | 10 | 4 | 14 |
| France | 71 | 97 | 168 |
| Germany | 24 | 14 | 38 |
| Spain | 29 | 22 | 51 |
| Baseline Melanoma Characteristics(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| Primary Histology - Cutaneous | 210 | 203 | 413 |
| Primary Histology - Mucosal | 14 | 12 | 26 |
| Primary Histology - Other | 18 | 23 | 41 |
| Primary Histology - Missing | 1 | 0 | 1 |
| Baseline Melanoma Staging(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| IIIA | 0 | 1 | 1 |
| IIIB | 0 | 2 | 2 |
| IIIC | 20 | 35 | 55 |
| IVM1A | 36 | 24 | 60 |
| IVM1B | 46 | 24 | 70 |
| IVM1C | 137 | 147 | 284 |
| Other | 4 | 5 | 9 |
| Baseline Elevated LDH (lactate dehydrogenase)(Participants) | Arm A: Ipilimumab | Arm B: IMO-2125 Plus Ipilimumab | Total |
|---|---|---|---|
| Yes | 124 | 126 | 250 |
| No | 112 | 106 | 218 |
| Unknown | 7 | 6 | 13 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Jun 2021, 36 months.
Results were first posted in Nov 2022, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tilsotolimod · Ipilimumab
Idera Pharmaceuticals, Inc.