A Phase 1/2 interventional study of MCS110 and Dabrafenib in Melanoma, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Dana-Farber Cancer Institute · Phase 1/2, Interventional, and Treatment
This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation.
The interventions involved in this study are:
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved MSC110 as a treatment for any disease.
The FDA has approved dabrafenib and trametinib as treatment options for this disease.
Dabrafenib and trametinib attack different proteins that promote the growth of cancerous cells. These two treatments work in cancers with a mutation in the BRAF gene which alters a protein signaling pathway in cancer cells. The BRAF mutation status will be confirmed during this trial by review or procedure in order to make sure this clinical trial is right for the participant. Dabrafenib is a BRAF inhibitor that works by preventing altered BRAF proteins from stimulating the growth of the melanoma cancer cells. Trametinib works by blocking a protein related to BRAF called MEK that has been known to stimulate cells that also promote melanoma growth. In order to participate in the study, the participant disease needs to be tested positive for a mutation (a permanent change in the DNA sequence of a gene) of the BRAF gene that belongs to a class of genes known as oncogenes. When mutated, oncogenes have the potential to cause normal cells to become cancerous. Once the BRAF gene is mutated, the normal functioning of the BRAF protein may be changed. It is normal for patients with a BRAF mutation to receive these types of inhibitor therapies at some point in their treatment.
MCS110 is a colony-stimulating factor-1 (CSF-1) inhibitor. It is a human monoclonal antibody which binds CSF-1. A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. MCS110 is being developed as a treatment for patients with advanced cancer.
In this research study, the investigators are adding MCS110 to the treatment with dabrafenib and trametinib at the time when the participant's disease is growing despite these medications. The hope is that MCS110 will enhance how the cancer will respond to dabrafenib and trametinib and overcome any resistance to these medications that has developed. In previous laboratory studies performed by treating melanoma cancer cells with a CSF-1R (CSF-1 Receptor which interacts with the CSF-1 protien) inhibitor and a BRAF inhibitor, it was found that the CSF-1R inhibitor was successful in increasing efficacy.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Participants must have normal organ and marrow function as defined below:
The effects of MCS110, trametinib and dabrafenib on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of and men must agree to use adequate (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months after the last dose of MCS110. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MCS110 administration. Highly Effective contraception methods include:
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.
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 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 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.
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).
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.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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 US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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.
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.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
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.
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.
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.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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.
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.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* MCS110 2.5mg/kg will be administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
Drug: MCS110 · Drug: Dabrafenib · Drug: Trametinib
* MCS110 will be administered intravenously every 3 weeks. The Dosage will be determined by the DLT of Phase 1 * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
Drug: MCS110 · Drug: Dabrafenib · Drug: Trametinib
* MCS110 1.25 mg/kg was administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
Drug: MCS110 · Drug: Dabrafenib · Drug: Trametinib
* MCS110 5mg/kg was administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
Drug: MCS110 · Drug: Dabrafenib · Drug: Trametinib
* MCS110 10mg/kg was administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
Drug: MCS110 · Drug: Dabrafenib · Drug: Trametinib
MCS110 is a colony-stimulating factor-1 (CSF-1) inhibitor. It is a human monoclonal antibody which binds CSF-1.
Dabrafenib attack different proteins that promote the growth of cancerous cells
Also known as: Tafinlar
Trametinib attack different proteins that promote the growth of cancerous cells
Also known as: Mekinist
Number of Participants With Dose Limiting Toxicities (DLT) [Phase I]
A DLT was defined as an adverse event that (a) was possibly, probably, or definitely related to the study medication regimen and (b) experienced during the first cycle of treatment, and (c) met any of the following criteria: ≥ Grade 3 non-hematological toxicity; grade 3 thrombocytopenia with clinically significant bleeding; grade 4 thrombocytopenia; ≥ grade 3 febrile neutropenia; grade 4 anemia; holding of any study medication due to toxicity for a period of greater than 8 consecutive days or two separate periods of any duration during the first cycle, any other significant toxicity deemed by the principal investigator to be dose limiting.
Time frame: Participants were followed up to 21 days.
Maximum Tolerated Dose of MCS110 [Phase I]
The trial used 3+3 design to determine maximum tolerated dose (MTD), escalating on 0/3 or 1/6 DLTs, and de-escalating if two DLTs were encountered. See subsequent primary outcome measure for the DLT definition. MTD was the highest dose level at which 0/3 or 1/6 subjects experienced a DLT.
Time frame: Participants were followed up to 21 days.
Overall Response Rate (ORR) [Phase I]
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time frame: Participants were followed up to 30 months.
Median Progression Free Survival [Phase I]
PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Time frame: Participants were followed up to 30 months.
Participants were enrolled from September 2018 to July 2019.
| Milestone | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1] | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level -1] | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 2] | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 3] | MCS110 + Trametinib + Dabrafenib [Phase 2] |
|---|---|---|---|---|---|
| Started | 6 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 6 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Disease progression | 4 | 0 | 0 | 0 | 0 |
| Withdrew: On treatment | 1 | 0 | 0 | 0 | 0 |
A DLT was defined as an adverse event that (a) was possibly, probably, or definitely related to the study medication regimen and (b) experienced during the first cycle of treatment, and (c) met any of the following criteria: ≥ Grade 3 non-hematological toxicity; grade 3 thrombocytopenia with clinically significant bleeding; grade 4 thrombocytopenia; ≥ grade 3 febrile neutropenia; grade 4 anemia; holding of any study medication due to toxicity for a period of greater than 8 consecutive days or two separate periods of any duration during the first cycle, any other significant toxicity deemed by the principal investigator to be dose limiting.
| Participants | MCS110+ Trametinib + Dabrafenib |
|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) [Phase I] | 1 |
The trial used 3+3 design to determine maximum tolerated dose (MTD), escalating on 0/3 or 1/6 DLTs, and de-escalating if two DLTs were encountered. See subsequent primary outcome measure for the DLT definition. MTD was the highest dose level at which 0/3 or 1/6 subjects experienced a DLT.
| mg/kg | MCS110+ Trametinib + Dabrafenib |
|---|---|
| Maximum Tolerated Dose of MCS110 [Phase I] | 2.5 |
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| percentage of participants | MCS110+ Trametinib + Dabrafenib |
|---|---|
| Overall Response Rate (ORR) [Phase I] | 16.7 (1 to 58) |
PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
| months | MCS110+ Trametinib + Dabrafenib |
|---|---|
| Median Progression Free Survival [Phase I] | 2.3 (1.3 to NA) |
Grade 3 adverse event (AE) rate was defined as the proportion of patients who experienced grade 3 adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version 4 (see standard source vocabulary as per AE module). Descriptions of severity (grade) are dependent on AE type with a scale of 1 (least severe) to 5. Please refer to https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm Per their definitions: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
| proportion of participants | MCS110+ Trametinib + Dabrafenib |
|---|---|
| Grade 3 Adverse Events Rate | 0.83 (0.42 to 0.99) |
OS based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.
| months | MCS110+ Trametinib + Dabrafenib |
|---|---|
| Median Overall Survival (OS) | 5.3 (3.4 to NA) |
Collected over Participants were followed up to 30 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCS110+ Trametinib + Dabrafenib [Phase I Dose Level I] | 3/6 (50%) | 1/6 (16.7%) | 6/6 (100%) |
| MCS110 + Trametinib + Dabrafenib Phase 2 | — | — | — |
| Event | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level I] | MCS110 + Trametinib + Dabrafenib Phase 2 |
|---|---|---|
| Alkaline phosphatase increasedInvestigations | 1/6 | — |
| Event | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level I] | MCS110 + Trametinib + Dabrafenib Phase 2 |
|---|---|---|
| Aspartate aminotransferase increasedInvestigations | 6/6 | — |
| FeverGeneral disorders | 5/6 | — |
| CPK increasedInvestigations | 5/6 | — |
| AnemiaBlood and lymphatic system disorders | 4/6 | — |
| DiarrheaGastrointestinal disorders | 4/6 | — |
| NauseaGastrointestinal disorders | 4/6 | — |
| VomitingGastrointestinal disorders | 4/6 | — |
| ChillsGeneral disorders | 4/6 | — |
| HypophosphatemiaMetabolism and nutrition disorders | 4/6 | — |
| FatigueGeneral disorders | 3/6 | — |
Zero patients were enrolled in the Phase 2 portion of this study.
| Age, Continuous(years) | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1] | MCS110 + Trametinib + Dabrafenib [Phase 2] | Total |
|---|---|---|---|
| Mean | 53.7 ± 17.1 | — | 53.7 ± 17.1 |
| Sex: Female, Male(Participants) | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1] | MCS110 + Trametinib + Dabrafenib [Phase 2] | Total |
|---|---|---|---|
| Female | 3 | — | 3 |
| Male | 3 | — | 3 |
| Ethnicity (NIH/OMB)(Participants) | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1] | MCS110 + Trametinib + Dabrafenib [Phase 2] | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 6 | — | 6 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1] | MCS110 + Trametinib + Dabrafenib [Phase 2] | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 0 | — | 0 |
| White | 6 | — | 6 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1] | MCS110 + Trametinib + Dabrafenib [Phase 2] | Total |
|---|---|---|---|
| United States | 6 | — | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Sep 2023, 59 months.
Results were first posted in Jul 2024, 10 months after primary completion.
Of 85 non-industry phase 1/2 interventional studies under Melanoma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 47 and three quarters within 98. This study's 59 months is close to that.
Counting every sponsor, half of 220 studies reached it within 61 months; a quarter within 42 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lacnotuzumab
Dana-Farber Cancer Institute →