CompletedPhase 2

Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial

France129 participantsStarted 2015-06

Plain-language summary

This is a multicenter study assessing the efficacy of different therapeutic strategy in patients with advanced sarcomas.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histology : Leiomyosarcoma, or UPS, or other sarcoma, or GIST or osteosarcoma, or soft-tissue sarcoma with presence of tertiary lymphoid structures (stratum 6) histologically confirmed by central review.
✓. Advanced non resectable / metastatic disease for strata 1 to 6. For stratum 7: locally advanced or metastatic disease with at least one injectable lesion.
✓. Documented progression according to RECIST criteria. Progression on the last line of treatment should be confirmed by central review with two radiological assessments identical obtained at less than 6 months interval within the 12 months before inclusion.
✓. For stratum 5, documented disease progression according to RECIST criteria after the first line imatinib and second line sunitinib.
✓. Have provided tissue of a tumor lesion from an archival tissue sample obtained on metastasis or on locally advanced disease, or newly obtained core or excisional biopsy. For strata 6 and 7, tissue \< 3 months old and with no subsequent treatment since or from a newly obtained biopsy.
✓. For strata 1, 2, 3 and 6: no more of four previous lines of systemic therapy for metastatic disease and no more than 2 previous line for stratum 7.
✓. Age ≥ 18 years.
✓. ECOG performance status ≤ 1.

✕. Previous treatment with MK3475 or CP or G100.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
✕. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases.
✕. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days.
✕. Previous enrolment in the present study.
✕. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons.
✕. Known hypersensitivity to any involved study drug or of its formulation components.

Percentage of Participants in Objective Response at 6 Months

Timeframe: 6 months from treatment initiation

Percentage of Particpants in Non-progression at 6 Months

Timeframe: 6 months from treatment initiation

NCT IDNCT02406781

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-24

Results submitted2025-09-11

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histology : Leiomyosarcoma, or UPS, or other sarcoma, or GIST or osteosarcoma, or soft-tissue sarcoma with presence of tertiary lymphoid structures (stratum 6) histologically confirmed by central review.
✓. Advanced non resectable / metastatic disease for strata 1 to 6. For stratum 7: locally advanced or metastatic disease with at least one injectable lesion.
✓. Documented progression according to RECIST criteria. Progression on the last line of treatment should be confirmed by central review with two radiological assessments identical obtained at less than 6 months interval within the 12 months before inclusion.
✓. For stratum 5, documented disease progression according to RECIST criteria after the first line imatinib and second line sunitinib.
✓. Have provided tissue of a tumor lesion from an archival tissue sample obtained on metastasis or on locally advanced disease, or newly obtained core or excisional biopsy. For strata 6 and 7, tissue \< 3 months old and with no subsequent treatment since or from a newly obtained biopsy.
✓. For strata 1, 2, 3 and 6: no more of four previous lines of systemic therapy for metastatic disease and no more than 2 previous line for stratum 7.
✓. Age ≥ 18 years.
✓. ECOG performance status ≤ 1.

✕. Previous treatment with MK3475 or CP or G100.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
✕. Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases.
✕. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
✕. Participation to a study involving a medical or therapeutic intervention in the last 30 days.
✕. Previous enrolment in the present study.
✕. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons.
✕. Known hypersensitivity to any involved study drug or of its formulation components.