Trial · NCT02406781
Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial
NCT02406781, Phase 2, Completed, Institut Bergonié; results first posted 2025-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial. Trials, record NCT02406781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02406781
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial
- NCT number
- NCT02406781
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Institut Bergonié
- Conditions
- Sarcoma
- Interventions
- Combination of MK3475 with Metronomic CP, Combination of MK3475 with Metronomic CP and G100
- First posted
- 2015-04-02
- Last updated
- 2025-12-10
- Other registries' IDs
- eudract:2014-004568-39
- Results first posted
- 2025-12-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Objective Response at 6 Months | 6 months from treatment initiation | 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 |
| Primary | Percentage of Particpants in Non-progression at 6 Months | 6 months from treatment initiation | 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. |
| Secondary | Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | 6 months from treatment initiation | 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). |
| Secondary | Median Progression-free Survival | From start of treatment, and during treatment until progression or death for any cause, whichever occurs first, for up to 12 months. | 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. |
| Secondary | Median Overall Survival | From start of treatment, and during treatment until death for any cause for up to 30 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Objective Response at 6 Months | 6 months from treatment initiation | Population eligible and assessable for the primary endpoint: eligible patients who received at least one administration of PEMBROLIZUMAB and one administration of Metronomic CP. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Particpants in Non-progression at 6 Months | 6 months from treatment initiation | Population eligible and assessable for the primary endpoint: eligible patients who received at least:~* For all strata (except for stratum 7): one administration of PEMBROLIZUMAB and one administration of Metronomic CP~* For stratum 7: one administration of PEMBROLIZUMAB and one administration of Metronomic CP and one administration of G100. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | 6 months from treatment initiation | Population eligible and assessable for the primary endpoint: eligible patients who received at least:~* For all strata (except for stratum 7): one administration of PEMBROLIZUMAB and one administration of Metronomic CP~* For stratum 7: one administration of PEMBROLIZUMAB and one administration of Metronomic CP and one administration of G100. | percentage of participants | NUMBER |
| SECONDARY | Median Progression-free Survival | From start of treatment, and during treatment until progression or death for any cause, whichever occurs first, for up to 12 months. | Population eligible and assessable for the primary endpoint: eligible patients who received at least:~* For all strata (except for stratum 7): one administration of PEMBROLIZUMAB and one administration of Metronomic CP~* For stratum 7: one administration of PEMBROLIZUMAB and one administration of Metronomic CP and one administration of G100. | months | MEDIAN |
| SECONDARY | Median Overall Survival | From start of treatment, and during treatment until death for any cause for up to 30 months | Population eligible and assessable for the primary endpoint: eligible patients who received at least:~* For all strata (except for stratum 7): one administration of PEMBROLIZUMAB and one administration of Metronomic CP~* For stratum 7: one administration of PEMBROLIZUMAB and one administration of Metronomic CP and one administration of G100. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Objective Response at 6 Months | Stratum 1: Advanced Leiomyosarcoma | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of participants | |
| Percentage of Participants in Objective Response at 6 Months | Stratum 2: Advanced Undifferentiated Sarcoma | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of participants | |
| Percentage of Participants in Objective Response at 6 Months | Stratum 3: Advanced Other Sarcoma | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of participants | |
| Percentage of Participants in Objective Response at 6 Months | Stratum 4: Advanced Osteosarcoma | 6.7 | 95% Confidence Interval 0.2 to 32.0 | percentage of participants | |
| Percentage of Particpants in Non-progression at 6 Months | Stratum 1: Advanced Leiomyosarcoma | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of participants | |
| Percentage of Particpants in Non-progression at 6 Months | Stratum 2: Advanced Undifferentiated Sarcoma | 7.1 | 95% Confidence Interval 0.2 to 33.9 | percentage of participants | |
| Percentage of Particpants in Non-progression at 6 Months | Stratum 3: Advanced Other Sarcoma | 14.3 | 95% Confidence Interval 1.8 to 42.8 | percentage of participants | |
| Percentage of Particpants in Non-progression at 6 Months | Stratum 4: Advanced GIST | 13.3 | 95% Confidence Interval 1.7 to 40.5 | percentage of participants | |
| Percentage of Particpants in Non-progression at 6 Months | Stratum 5: Advanced Soft-tissue Sarcomas | 11.1 | 95% Confidence Interval 2.8 to 48.3 | percentage of participants | |
| Percentage of Particpants in Non-progression at 6 Months | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | 40 | 95% Confidence Interval 22.7 to 59.4 | percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1: Advanced Leiomyosarcoma | 15 | |
| Overall Study | STARTED | Stratum 2: Advanced Undifferentiated Sarcoma | 16 | |
| Overall Study | STARTED | Stratum 3: Advanced Other Sarcoma | 16 | |
| Overall Study | STARTED | Stratum 4: Advanced GIST | 17 | |
| Overall Study | STARTED | Stratum 5: Advanced Soft-tissue Sarcomas | 10 | |
| Overall Study | STARTED | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | 35 | |
| Overall Study | STARTED | Stratum 7: Metastatic Soft-tissue Sarcoma. | 20 | |
| Overall Study | COMPLETED | Stratum 1: Advanced Leiomyosarcoma | 13 | |
| Overall Study | COMPLETED | Stratum 2: Advanced Undifferentiated Sarcoma | 14 | |
| Overall Study | COMPLETED | Stratum 3: Advanced Other Sarcoma | 14 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,470
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Stratum 1: Advanced Leiomyosarcoma | 3 | 15 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 2: Advanced Undifferentiated Sarcoma | 4 | 16 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 3: Advanced Other Sarcoma | 9 | 16 | 11 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 4: Advanced GIST | 4 | 16 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 5: Advanced Soft-tissue Sarcomas | 2 | 10 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | 8 | 35 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Stratum 7: Metastatic Soft-tissue Sarcoma. | 5 | 19 | 5 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Stratum 1: Advanced Leiomyosarcoma | 0 | 15 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Stratum 2: Advanced Undifferentiated Sarcoma | 1 | 16 | 1 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Stratum 3: Advanced Other Sarcoma | 0 | 16 | 0 |
1 to 10 of 1,470Source ClinicalTrials.gov
See all 1,470 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1: Advanced Leiomyosarcoma | 13 | 15 |
| Total, all-cause mortality | Stratum 2: Advanced Undifferentiated Sarcoma | 14 | 16 |
| Total, all-cause mortality | Stratum 3: Advanced Other Sarcoma | 7 | 16 |
| Total, all-cause mortality | Stratum 4: Advanced GIST | 12 | 16 |
| Total, all-cause mortality | Stratum 5: Advanced Soft-tissue Sarcomas | 3 | 10 |
| Total, all-cause mortality | Stratum 6: Advanced Soft-tissue Sarcomas With Immune Signature | 15 | 35 |
| Total, all-cause mortality | Stratum 7: Metastatic Soft-tissue Sarcoma. | 9 | 19 |
| Total, other adverse events | Stratum 1: Advanced Leiomyosarcoma | 15 | 15 |
| Total, other adverse events | Stratum 2: Advanced Undifferentiated Sarcoma | 16 | 16 |
| Total, other adverse events | Stratum 3: Advanced Other Sarcoma | 16 | 16 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02406781
GET https://conductscience.org/api/trials/v1/NCT02406781/results?page=2