A Phase 2 interventional study of Combination of MK3475 with Metronomic CP and Combination of MK3475 with Metronomic CP and G100 in Sarcoma, sponsored by Institut Bergonié. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Institut Bergonié · Phase 2, Interventional, and Treatment
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Among 22 studies in Sarcoma by Institut Bergonié — 6 open to participants now, 9 under way, 1 of them phase 3. Sarcoma · Institut Bergonié.
Among the 22 studies in Sarcoma by Institut Bergonié, this one is the 6th largest by enrollment of the 18 interventional ones that give a count, is one of 3 that started in 2015, is one of 8 in phase 2, and was the 1st registered.
1,607 studies on the registry are indexed under Sarcoma; 365 are open to participants now.
Browse Sarcoma studies →6 of the 22 studies in Sarcoma by Institut Bergonié are open now, in 1 country. Recruiting first, the newest first:
Institut Bergonié · Sites in France
Ages 15–49
Institut Bergonié · Sites in France
Ages 18+
Institut Bergonié · Sites in France
Ages 18+
Institut Bergonié · Sites in France
Ages 18+
Institut Bergonié · Sites in France
Ages 18+
By country, each count listing its studies:
Of the 301 Sarcoma studies recruiting now, 191 (63%) set no upper age limit and 83 (28%) stop at 75 or younger; 92 take children under 18; 12 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.
22 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 5 · Phase 2 11 · Phase 3 1
First in 1990; this study’s year is marked. 3 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 129 is above the median of 41 across 1,254 interventional studies indexed under Sarcoma.
Median enrollment 69 across the 18 interventional studies, 1,256 across the 4 observational. Of the 11 that completed or were terminated, 7 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
4 of the studies in Sarcoma by Institut Bergonié that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03805022Phase 3Institut BergoniéBenefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas | 2026-12 |
| NCT02789384Institut BergoniéCINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. | 2026-12 |
| NCT05182164Institut BergoniéCombination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas | 2026-12 |
| NCT04874311Institut BergoniéBintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma | 2027-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 22 studies in Sarcoma by Institut Bergonié, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a multicenter study assessing the efficacy of different therapeutic strategy in patients with advanced sarcomas.
This is a phase 2 trial with 7 strata :
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.
Adequate hematological, renal, metabolic and hepatic function:
Exclusion Criteria:
For strata 6 to 7:
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 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 line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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 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 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.
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 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 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.
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.
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.
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.
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.
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 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.
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.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced leiomyosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally.
Drug: Combination of MK3475 with Metronomic CP
Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced undifferentiated sarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally.
Drug: Combination of MK3475 with Metronomic CP
Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced other sarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally.
Drug: Combination of MK3475 with Metronomic CP
Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced osteosarcoma. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally.
Drug: Combination of MK3475 with Metronomic CP
Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced GIST. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally.
Drug: Combination of MK3475 with Metronomic CP
Treatment strategy A: Combination of MK3475 with Metronomic CP administered to patients with advanced soft-tissue sarcomas with immune signature. MK3475 will be administered intraveinously. Metronomic CP (Cyclophosphamide) will be adminstered orally.
Drug: Combination of MK3475 with Metronomic CP
Treatment strategy B: Combination of MK3475 with Metronomic CP and G100 adminitrered to patients with metastatic soft-tissue sarcoma. MK3475 will be administered intravenously. Metronomic CP (Cyclophosphamide) will be administered orally. G100 will be administered by intra-tumoral injection.
Drug: Combination of MK3475 with Metronomic CP and G100
Combination of MK3475 with Metronomic CP. Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Also known as: Pembrolizumab, Endoxan
Combination of MK3475 with Metronomic CP and G100. Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule. MK3475 will be administered intravenously (200 mg), and given every 3 weeks on day 8. G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase). A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
Also known as: Pembrolizumab, Endoxan, GLA-SE (glucopyranosyl lipid adjuvant-stable emulsion).
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Percentage of Participants in Objective Response at 6 Months
Objective response is defined according to RECIST v1.1 as either complete response (disappearance of all target lesions, with any pathological lymph nodes reduced in short axis to \<10 mm) or partial response (≥30% decrease in the sum of diameters of target lesions compared with baseline). This primary endpoint is part of a dual endpoint encompassing both non-progression and objective response at 6 months (non-progression is presented as a separate primary outcome). ORR at 6 months will be evaluated only in the following strata: Stratum 1: Advanced leiomyosarcoma ; Stratum 2: Advanced undifferentiated sarcoma ; Stratum 3: Advanced other sarcoma ; Stratum 4: Advanced osteosarcoma
Time frame: 6 months from treatment initiation
Percentage of Particpants in Non-progression at 6 Months
Non-progression is defined as the absence of progressive disease according to RECIST v1.1. Progressive disease defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). This outcome will be assessed as a stand-alone primary endpoint in the following strata: Stratum 5: Advanced gastrointestinal stromal tumor (GIST) ; Stratum 6: Advanced soft tissue sarcomas with immune signature ; Stratum 7: Metastatic soft tissue sarcoma (STS) In strata 1 to 4, non-progression is considered as part of the dual primary endpoint together with objective response at 6 months.
Time frame: 6 months from treatment initiation
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1.
Best overall response is defined as the best response across all time points (RECIST v1.1). The best overall response is determined once all the data for the participant is known. Each patient has been assigned one of the following categories (RECIST 1.1): complete response (disappearance of all target lesions); partial response (\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); progression (20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and stable disease (nor CR, PR or progression).
Time frame: 6 months from treatment initiation
Median Progression-free Survival
Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. Progressive disease defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1. Progression-free survival is estimated as a function of time using Kaplan-Meier method.
Time frame: From start of treatment, and during treatment until progression or death for any cause, whichever occurs first, for up to 12 months.
Median Overall Survival
Overall survival (OS) defined as the time from randomization to death (due to any cause). Patients alive were censored at the date of last follow-up or last patient contact. Overall survival was estimated as a function of time using Kaplan-Meier method.
Time frame: From start of treatment, and during treatment until death for any cause for up to 30 months
8 centers: * Institut Bergonié, Pr Italiano * Centre Léon Bérard, Pr Blay * Institut Gustave Roussy, Dr Le Cesne * Centre Oscar Lambret, Dr Penel * Institut Curie, Dr Piperno-Neumann * Institut Paoli Calmette, Pr Bertucci * Institut Claudius Regaud, Dr Chevreau * Institut de Cancérologie de l'Ouest - Site René Gauducheau, Dr Bompas Planned enrollment period : 72 months Treatment duration : 2-years maximum Follow-up : 12 months Duration of study : 7 years
| Milestone | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| Started | 15 | 16 | 16 | 17 | 10 | 35 | 20 |
| Completed | 13 | 14 | 14 | 15 | 9 | 30 | 17 |
| Not completed | 2 | 2 | 2 | 2 | 1 | 5 | 3 |
| Withdrew: Protocol violation | 2 | 2 | 2 | 2 | 1 | 5 | 3 |
Objective response is defined according to RECIST v1.1 as either complete response (disappearance of all target lesions, with any pathological lymph nodes reduced in short axis to \<10 mm) or partial response (≥30% decrease in the sum of diameters of target lesions compared with baseline). This primary endpoint is part of a dual endpoint encompassing both non-progression and objective response at 6 months (non-progression is presented as a separate primary outcome). ORR at 6 months will be evaluated only in the following strata: Stratum 1: Advanced leiomyosarcoma ; Stratum 2: Advanced undifferentiated sarcoma ; Stratum 3: Advanced other sarcoma ; Stratum 4: Advanced osteosarcoma
| percentage of participants | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced Osteosarcoma |
|---|---|---|---|---|
| Percentage of Participants in Objective Response at 6 Months | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) | 6.7 (0.2 to 32.0) |
Non-progression is defined as the absence of progressive disease according to RECIST v1.1. Progressive disease defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). This outcome will be assessed as a stand-alone primary endpoint in the following strata: Stratum 5: Advanced gastrointestinal stromal tumor (GIST) ; Stratum 6: Advanced soft tissue sarcomas with immune signature ; Stratum 7: Metastatic soft tissue sarcoma (STS) In strata 1 to 4, non-progression is considered as part of the dual primary endpoint together with objective response at 6 months.
| percentage of participants | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| Percentage of Particpants in Non-progression at 6 Months | 0.0 (0.0 to 0.0) | 7.1 (0.2 to 33.9) | 14.3 (1.8 to 42.8) | 13.3 (1.7 to 40.5) | 11.1 (2.8 to 48.3) | 40 (22.7 to 59.4) | 11.8 (1.5 to 36.4) |
Best overall response is defined as the best response across all time points (RECIST v1.1). The best overall response is determined once all the data for the participant is known. Each patient has been assigned one of the following categories (RECIST 1.1): complete response (disappearance of all target lesions); partial response (\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); progression (20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and stable disease (nor CR, PR or progression).
| percentage of participants | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| Complete response (CR) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Partial response (PR) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 6.7 (0.2 to 32.0) | 0 (0 to 0) | 26.7 (12.3 to 45.9) | 5.9 (0.2 to 28.7) |
| Stable disease (SD) | 23.1 (5.0 to 53.8) | 35.7 (12.8 to 64.9) | 35.7 (12.8 to 64.9) | 33.3 (11.8 to 61.6) | 33.3 (7.5 to 70.1) | 36.7 (19.9 to 56.1) | 23.5 (6.8 to 49.9) |
| Progression (PD) | 76.9 (46.2 to 95.0) | 50.0 (23.0 to 77.0) | 57.1 (28.9 to 82.3) | 53.3 (26.6 to 78.7) | 66.7 (29.9 to 92.5) | 33.3 (17.3 to 52.8) | 70.6 (44.0 to 89.7) |
| Not evaluable for response (NE) | 0 (0 to 0) | 14.3 (1.8 to 42.8) | 7.1 (0.2 to 33.9) | 6.7 (0.2 to 32.0) | 0 (0 to 0) | 3.3 (0.1 to 17.2) | 0 (0 to 0) |
Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. Progressive disease defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1. Progression-free survival is estimated as a function of time using Kaplan-Meier method.
| months | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| Median Progression-free Survival | 1.4 (1.2 to 1.4) | 1.3 (1.1 to 2.9) | 1.4 (0.9 to 4.0) | 1.4 (1.0 to 1.4) | 1.4 (0.9 to 5.3) | 4.1 (1.4 to 12.5) | 1.8 (1.5 to 4.1) |
Overall survival (OS) defined as the time from randomization to death (due to any cause). Patients alive were censored at the date of last follow-up or last patient contact. Overall survival was estimated as a function of time using Kaplan-Meier method.
| months | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| Median Overall Survival | 15.1 (4.4 to 17.9) | 6.7 (3.2 to 20.0) | 7.1 (2.0 to 16.3) | 5.6 (2.1 to 12.1) | NA (NA to NA) | 18.3 (8.5 to NA) | 25.2 (8.5 to NA) |
Collected over Adverse events (serious and non-serious) and deaths were reported for 90 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first, up to 30 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stratum 1: Advanced Leiomyosarcoma | 13/15 (86.7%) | 5/15 (33.3%) | 15/15 (100%) |
| Stratum 2: Advanced Undifferentiated Sarcoma | 14/16 (87.5%) | 10/16 (62.5%) | 16/16 (100%) |
| Stratum 3: Advanced Other Sarcoma | 7/16 (43.8%) | 9/16 (56.3%) | 16/16 (100%) |
| Stratum 4: Advanced GIST | 12/16 (75%) | 12/16 (75%) | 16/16 (100%) |
| Stratum 5: Advanced Soft-tissue Sarcomas | 3/10 (30%) | 9/10 (90%) | 10/10 (100%) |
| Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | 15/35 (42.9%) | 14/35 (40%) | 35/35 (100%) |
| Stratum 7: Metastatic Soft-tissue Sarcoma. | 9/19 (47.4%) | 8/19 (42.1%) | 19/19 (100%) |
| Event | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 0/15 | 2/16 | 2/16 | 2/16 | 2/10 | 1/35 | 0/19 |
| SpesisInfections and infestations | 1/15 | 0/16 | 0/16 | 0/16 | 2/10 | 1/35 | 0/19 |
| DehydrationMetabolism and nutrition disorders | 0/15 | 0/16 | 0/16 | 0/16 | 2/10 | 0/35 | 0/19 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/15 | 3/16 | 1/16 | 2/16 | 0/10 | 1/35 | 0/19 |
| General disorders and administration site conditionsGeneral disorders | 2/15 | 1/16 | 2/16 | 1/16 | 1/10 | 1/35 | 0/19 |
| Tumor painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/15 | 0/16 | 1/16 | 1/16 | 0/10 | 0/35 | 2/19 |
| Infections and infestations - Other, specifyInfections and infestations | 0/15 | 0/16 | 0/16 | 2/16 | 0/10 | 0/35 | 0/19 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/15 | 1/16 | 2/16 | 1/16 | 0/10 | 1/35 | 0/19 |
| FeverGeneral disorders | 0/15 | 0/16 | 0/16 | 0/16 | 0/10 | 4/35 | 0/19 |
| Gastric perforationGastrointestinal disorders | 0/15 | 0/16 | 0/16 | 0/16 | 1/10 | 0/35 | 0/19 |
| Event | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. |
|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders | 11/15 | 7/16 | 11/16 | 8/16 | 9/10 | 23/35 | 10/19 |
| AnemiaBlood and lymphatic system disorders | 3/15 | 4/16 | 9/16 | 4/16 | 2/10 | 8/35 | 5/19 |
| Tumor painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/15 | 1/16 | 3/16 | 2/16 | 0/10 | 6/35 | 10/19 |
| NauseaGastrointestinal disorders | 2/15 | 2/16 | 3/16 | 4/16 | 2/10 | 13/35 | 9/19 |
| Lymphocyte count decreasedInvestigations | 2/15 | 2/16 | 1/16 | 1/16 | 0/10 | 16/35 | 7/19 |
| Abdominal painGastrointestinal disorders | 1/15 | 2/16 | 1/16 | 1/16 | 4/10 | 7/35 | 3/19 |
| GGT increasedInvestigations | 0/15 | 1/16 | 2/16 | 1/16 | 4/10 | 3/35 | 0/19 |
| AnorexiaMetabolism and nutrition disorders | 1/15 | 3/16 | 6/16 | 4/16 | 4/10 | 3/35 | 0/19 |
| PainGeneral disorders | 1/15 | 1/16 | 0/16 | 6/16 | 2/10 | 0/35 | 1/19 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/15 | 1/16 | 1/16 | 2/16 | 1/10 | 2/35 | 2/19 |
* Eligible population: All patients included without major violation of eligibility criteria. * Population eligible and assessable for the primary endpoint : eligible patients who received at least one administration of PEMBROLIZUMAB and one administration of Metronomic CP * Safety population: All patients with at least one treatment (any) administration.
| Age, Continuous(years) | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 63.7 (56.8 to 72.2) | 59.1 (55.9 to 64.4) | 55.5 (45.4 to 60.1) | 42.2 (22.3 to 52.0) | 57.9 (44.3 to 69.9) | 62.2 (45.2 to 77.1) | 62.7 (57.0 to 69.0) | 63 (57 to 70) |
| Sex: Female, Male(Participants) | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 8 | 5 | 6 | 7 | 5 | 16 | 10 | 57 |
| Male | 7 | 11 | 10 | 10 | 5 | 19 | 10 | 72 |
| Race and Ethnicity Not Collected(Participants) | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. | Total |
|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Stratum 1: Advanced Leiomyosarcoma | Stratum 2: Advanced Undifferentiated Sarcoma | Stratum 3: Advanced Other Sarcoma | Stratum 4: Advanced GIST | Stratum 5: Advanced Soft-tissue Sarcomas | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | Stratum 7: Metastatic Soft-tissue Sarcoma. | Total |
|---|---|---|---|---|---|---|---|---|
| France | 15 | 16 | 16 | 17 | 10 | 35 | 20 | 129 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2015 to primary completion in Nov 2020, 65 months.
Results were first posted in Dec 2025, 5 years after primary completion.
Of 198 non-industry phase 2 interventional studies under Sarcoma, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 46 and three quarters within 91. This study's 65 months is close to that.
Counting every sponsor, half of 227 studies reached it within 66 months; a quarter within 43 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab