A Phase 2 interventional study of IMO-2125 and Ipilimumab in Metastatic Melanoma, sponsored by Idera Pharmaceuticals, Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Idera Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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Among 2,048 studies in Melanoma with a site in United States — 243 open to participants now, 439 under way, 32 of them phase 3. Melanoma · United States.
Among the 2,048 studies in Melanoma with a site in United States, this one is the 674th largest by enrollment of the 1,748 interventional ones that give a count, is one of 108 that started in 2015, is one of 612 in phase 2, and was the 1,157th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →243 of the 2,048 studies in Melanoma with a site in United States are open now. Recruiting first, the newest first:
Children's Oncology Group · Sites in United States
Ages up to 25
John Kirkwood · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18+
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
Ages 18+ · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 55+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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.
2,048 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 1 934 · Phase 2 907 · Phase 3 115 · Phase 4 11
First in 1991; this study’s year is marked. 108 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 53 is above the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 37 across the 1,748 interventional studies, 156 across the 212 observational. Of the 1,481 that completed or were terminated, 598 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
799 of 2,048 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.
141 of the studies in Melanoma with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT05987332Phase 3IDEAYA BiosciencesIDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma | 2027-01-15 |
| NCT06246916Phase 3Regeneron PharmaceuticalsA Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | 2027-03-22 |
| NCT01223248Phase 3Memorial Sloan Kettering Cancer CenterRandomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy | 2027-10 |
| NCT06112314Phase 3Immunocore LtdIMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) | 2027-10-16 |
Add all 141 to your calendar (.ics) → With an account.
Among the 2,048 studies in Melanoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when administered in combination with ipilimumab or pembrolizumab.
The open-label single-arm Phase 2 study was designed to assess the recommended dose for safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of 8 mg IMO-2125 (tilsotolimod) when administered in combination with ipilimumab.
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 symptomatic or radiographic progression during or after treatment with a PD-(L)1 inhibitor administered either as monotherapy or in combination.
Prior BRAF or MEK inhibitor treatment is not required. However, for patients with known BRAF status:
Previous treatment with either a inhibitor (for patients enrolling on the IMO-2125 + pembrolizumab combination) or CTLA-4 inhibitor (for patients enrolling on the IMO-2125 + ipilimumab combination if applicable) should not have been accompanied by DLT for which permanent discontinuation is recommended (per USPI).
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.
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.
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.
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.
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.
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
IMO-2125 intratumoral injection plus ipilimumab
Drug: IMO-2125 · Drug: Ipilimumab
Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.
Also known as: tilsotolimod (tilso)
4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Also known as: Yervoy®
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population (N=44) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) The ORR for 49 evaluable (4 non-evaluable) participants who received the recommended Phase 2 dose (RP2D) of 8 mg Tilso/Ipi 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. Overall Response = CR or PR
Time frame: 33 weeks (29 weeks of treatment, 4 weeks follow up)
Phase 2: Progression-free Survival
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Progression-free survival was defined as the number of months from the initiation of treatment to confirmed disease progression using RECIST v1.1 or death from any cause.
Time frame: 33 weeks (29 weeks of treatment, 4 weeks follow up)
Phase 2: Overall Survival - 6 Months
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=44 (40 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Overall survival was defined as the number of months from initiation of treatment to death from any cause.
Time frame: 6 months
Phase 2: Overall Survival - 12 Months
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Overall survival was defined as the number of months from initiation of treatment to death from any cause.
Time frame: 12 months
The Phase 2 study was conducted at nine (9) academic cancer centers.
| Milestone | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Started | 53 |
| Completed | 18 |
| Not completed | 35 |
| Withdrew: Death | 26 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Progressive disease | 1 |
| Withdrew: Study terminated by sponsor | 4 |
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population (N=44) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) The ORR for 49 evaluable (4 non-evaluable) participants who received the recommended Phase 2 dose (RP2D) of 8 mg Tilso/Ipi 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. Overall Response = CR or PR
| Participants | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Complete Response | 2 |
| Partial Response | 9 |
| Stable Disease | 24 |
| Progressive Disease | 14 |
| Non-evaluable | 4 |
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Progression-free survival was defined as the number of months from the initiation of treatment to confirmed disease progression using RECIST v1.1 or death from any cause.
| Participants | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Participants with disease progression or death | 41 |
| Participants who did not progress or die | 8 |
| Non-evaluable | 4 |
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=44 (40 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Overall survival was defined as the number of months from initiation of treatment to death from any cause.
| Participants | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Participants who died at or before 6 months | 6 |
| Participants who did not die at or before 6 months | 43 |
| Non-evaluable | 4 |
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Overall survival was defined as the number of months from initiation of treatment to death from any cause.
| Participants | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Participants who died at or before 12 months | 19 |
| Participants who did not die at or before 12 months | 30 |
| Non-evaluable | 4 |
Collected over From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 2, 8 mg Tilso/Ipi | 26/53 (49.1%) | 15/53 (28.3%) | 52/53 (98.1%) |
| Event | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Urinary tract infectionInfections and infestations | 2/53 |
| HyponatraemiaMetabolism and nutrition disorders | 1/53 |
| PneumoniaInfections and infestations | 1/53 |
| AnaemiaBlood and lymphatic system disorders | 1/53 |
| Anaphylactic reactionImmune system disorders | 1/53 |
| AstheniaGeneral disorders | 1/53 |
| Autoimmune colitisGastrointestinal disorders | 1/53 |
| DehydrationMetabolism and nutrition disorders | 1/53 |
| Depressed level of consciousnessNervous system disorders | 1/53 |
| DiarrhoeaGastrointestinal disorders | 1/53 |
| Event | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| FatigueGeneral disorders | 30/53 |
| NauseaGastrointestinal disorders | 22/53 |
| DiarrhoeaGastrointestinal disorders | 22/53 |
| AnaemiaBlood and lymphatic system disorders | 19/53 |
| PyrexiaGeneral disorders | 18/53 |
| Alanine aminotransferase increasedInvestigations | 16/53 |
| HeadacheNervous system disorders | 16/53 |
| ChillsGeneral disorders | 15/53 |
| VomitingGastrointestinal disorders | 15/53 |
| RashSkin and subcutaneous tissue disorders | 15/53 |
Includes all participants who received at least 1 dose of study treatment.
| Age, Continuous(years) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Mean | 64.6 ± 11.3 |
| Sex: Female, Male(Participants) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Female | 20 |
| Male | 33 |
| Ethnicity (NIH/OMB)(Participants) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 45 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 47 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(participants) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| United States | 53 |
| Body Mass Index(kg/m^2) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Mean | 28.9 ± 6.4 |
| Baseline Melanoma Characteristics(Participants) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| Primary Histology - Cutaneous | 42 |
| Primary Histology - Mucosal | 5 |
| Primary Histology - Other | 6 |
| Baseline Melanoma Stage(Participants) | Phase 2, 8 mg Tilso/Ipi |
|---|---|
| IIIA | 2 |
| IIIB | 2 |
| IIIC | 13 |
| IVM1A | 7 |
| IVM1B | 6 |
| IVM1C | 22 |
| Other: IV | 1 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2015 to primary completion in Feb 2020, 50 months.
Results were first posted in Aug 2022, 2 years 6 months after primary completion.
Of 106 industry-sponsored phase 2 interventional studies under Melanoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 60. This study's 50 months is above that.
Counting every sponsor, half of 384 studies reached it within 53 months; a quarter within 32 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tilsotolimod
Idera Pharmaceuticals, Inc.