NCT02406781 (PEMBROSARC) is a Phase 2 clinical trial of Combination of MK3475 with Metronomic CP in Sarcoma, sponsored by Institut Bergonié.

Who is sponsoring NCT02406781?

NCT02406781 is sponsored by Institut Bergonié.

What drugs are being tested in NCT02406781?

Interventions in NCT02406781: Combination of MK3475 with Metronomic CP, Combination of MK3475 with Metronomic CP and G100.

Is NCT02406781 still recruiting?

NCT02406781 is currently completed. Last updated 24 November 2025.

Are results published for NCT02406781?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-11-24 · How we verify

NCT02406781: PEMBROSARC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 24 November 2025

What this trial tests

Phase 2 trial testing Combination of MK3475 with Metronomic CP in Sarcoma in 129 participants. Completed in 15 January 2023.

Timeline

1 June 2015

Primary endpoint
24 November 2020

15 January 2023

Quick facts

Lead sponsor	Institut Bergonié
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	129
Start date	1 June 2015
Primary completion	24 November 2020
Estimated completion	15 January 2023
Sites	8 locations across France

Drugs / interventions tested

Combination of MK3475 with Metronomic CP — full drug profile →
Combination of MK3475 with Metronomic CP and G100 — full drug profile →

Conditions studied

Sarcoma — all drugs for Sarcoma →

Sponsor

Institut Bergonié — full company profile →

Who can join

18 and older, any sex, with Sarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants in Objective Response at 6 Months
Time frame: 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
Percentage of Particpants in Non-progression at 6 Months
Time frame: 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 increas

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Mature tertiary lymphoid structures predict immune checkpoint inhibitor efficacy in solid tumors independently of PD-L1 expression.
Vanhersecke L, Brunet M, Guégan JP, Rey C, et al · · 2021 · cited 458× · PMID 35118423 · DOI 10.1038/s43018-021-00232-6
Use of PD-1 Targeting, Macrophage Infiltration, and IDO Pathway Activation in Sarcomas: A Phase 2 Clinical Trial.
Toulmonde M, Penel N, Adam J, Chevreau C, et al · · 2018 · cited 322× · PMID 28662235 · DOI 10.1001/jamaoncol.2017.1617
Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort.
Italiano A, Bessede A, Pulido M, Bompas E, et al · · 2022 · cited 229× · PMID 35618839 · DOI 10.1038/s41591-022-01821-3
Trial watch: Immunogenic cell death induction by anticancer chemotherapeutics.
Garg AD, More S, Rufo N, Mece O, et al · · 2017 · cited 206× · PMID 29209573 · DOI 10.1080/2162402x.2017.1386829
Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
B cells and cancer: To B or not to B?
Fridman WH, Petitprez F, Meylan M, Chen TW, et al · · 2021 · cited 149× · PMID 33601413 · DOI 10.1084/jem.20200851
Advances on immunotherapy for osteosarcoma.
Yu S, Yao X. · · 2024 · cited 146× · PMID 39245737 · DOI 10.1186/s12943-024-02105-9
Programmed cell death 1 (PD-1) targeting in patients with advanced osteosarcomas: results from the PEMBROSARC study.
Le Cesne A, Marec-Berard P, Blay JY, Gaspar N, et al · · 2019 · cited 128× · PMID 31442817 · DOI 10.1016/j.ejca.2019.07.018

Verify or expand the search:

Other recruiting trials for Sarcoma

Currently open trials in the same condition.

NCT07402577 — Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot · recruiting
NCT07501026 — Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC) · Phase 2 · recruiting
NCT07359911 — Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patient · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting

Other Institut Bergonié trials

Trials by the same sponsor.

NCT06084689 — Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures · Phase 2 · withdrawn
NCT06700057 — Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer. · recruiting
NCT05690828 — Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer. · NA · active not recruiting
NCT05415527 — Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Mana · NA · active not recruiting
NCT04912687 — Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02406781 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut Bergonié
Last refreshed: 24 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02406781.

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