NCT04216953 (COTESARC) is a Phase 1, PHASE2 clinical trial of Cobimetinib in Sarcoma,Soft Tissue, sponsored by Centre Leon Berard.

Who is sponsoring NCT04216953?

NCT04216953 is sponsored by Centre Leon Berard.

What drugs are being tested in NCT04216953?

Interventions in NCT04216953: Cobimetinib, Atezolizumab.

What condition does NCT04216953 study?

NCT04216953 studies Sarcoma,Soft Tissue.

Is NCT04216953 still recruiting?

NCT04216953 is currently active, enrolled. Last updated 8 July 2024.

Last reviewed 2024-07-08 · How we verify

NCT04216953: COTESARC

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

MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma

Active, enrolled Phase 1, PHASE2 Last updated 8 July 2024

What this trial tests

Phase 1, PHASE2 trial testing Cobimetinib in Sarcoma,Soft Tissue in 320 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 February 2020

Primary endpoint
1 February 2026

1 February 2027

Quick facts

Lead sponsor	Centre Leon Berard
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	320
Start date	12 February 2020
Primary completion	1 February 2026
Estimated completion	1 February 2027
Sites	6 locations across France

Drugs / interventions tested

Cobimetinib (cobimetinib) — full drug profile →
Atezolizumab (atezolizumab) — full drug profile →

Conditions studied

Sarcoma,Soft Tissue — all drugs for Sarcoma,Soft Tissue →

Sponsor

Centre Leon Berard — full company profile →

Who can join

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

Sponsor's own description

The proposed study conducted in adult and pediatric patients aims to evaluate the safety and clinical activity of atezolizumab + cobimetinib in advanced/metastatic soft tissue sarcomas (up to 80 patients).

Publications & conference data

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

Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
Targeting MHC-I inhibitory pathways for cancer immunotherapy.
Wang J, Lu Q, Chen X, Aifantis I. · · 2024 · cited 46× · PMID 38433029 · DOI 10.1016/j.it.2024.01.009
Soft Tissue Sarcoma: An Insight on Biomarkers at Molecular, Metabolic and Cellular Level.
Pillozzi S, Bernini A, Palchetti I, Crociani O, et al · · 2021 · cited 29× · PMID 34207243 · DOI 10.3390/cancers13123044
Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
Is immunotherapy in the future of therapeutic management of sarcomas?
Clemente O, Ottaiano A, Di Lorenzo G, Bracigliano A, et al · · 2021 · cited 24× · PMID 33902630 · DOI 10.1186/s12967-021-02829-y
Neurofibromatosis in the Era of Precision Medicine: Development of MEK Inhibitors and Recent Successes with Selumetinib.
Galvin R, Galvin R, Watson AL, Largaespada DA, et al · · 2021 · cited 19× · PMID 33721151 · DOI 10.1007/s11912-021-01032-y
Molecular Targeting of the BRAF Proto-Oncogene/Mitogen-Activated Protein Kinase (MAPK) Pathway across Cancers.
Shan KS, Rehman TU, Ivanov S, Domingo G, et al · · 2024 · cited 18× · PMID 38203795 · DOI 10.3390/ijms25010624
Targeting tumor microenvironment and metastasis in children with solid tumors.
Wessel KM, Kaplan RN. · · 2022 · cited 11× · PMID 34812775 · DOI 10.1097/mop.0000000000001082

Verify or expand the search:

Other trials of Cobimetinib

Trials testing the same drug.

NCT06813079 — Using Tumor Models to Determine Treatments · Phase 2 · not yet recruiting
NCT06440850 — Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E · Phase 2 · recruiting
NCT05691504 — Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers · Phase 1 · active not recruiting
NCT05238831 — SMMART Adaptive Clinical Treatment (ACT) Trial · EARLY_PHASE1 · withdrawn
NCT05441514 — Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · active not recruiting

Other recruiting trials for Sarcoma,Soft Tissue

Currently open trials in the same condition.

NCT06835049 — Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue · Phase 2 · recruiting
NCT07066982 — Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas · Phase 1, PHASE2 · recruiting
NCT06660810 — Neoadjuvant Intralesional Injection of Talimogene Laherparepvec · Phase 2 · active not recruiting
NCT06637007 — Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma · Phase 2 · recruiting
NCT05813327 — Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma · Phase 1 · active not recruiting

Other Centre Leon Berard trials

Trials by the same sponsor.

NCT07499921 — Clinical and BIOgical Analyses of RECtal Tumors · NA · not yet recruiting
NCT07515274 — Evaluation of the Effects of Equicoaching on Social Reintegration Among Young Adults Who Have Been Treated for Cancer · NA · not yet recruiting
NCT07243483 — Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute My · NA · recruiting
NCT07334990 — Impact of a Hypnotic Recording on Artifacts in 4D CT in the Context of Stereotactic Body Radiation Therapy for Lung Canc · NA · not yet recruiting
NCT07414719 — Impact of an HPV Primary Prevention Intervention on HPV Vaccination Rates Among Adolescents in the AuRA Region. · NA · recruiting

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 NCT04216953 (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 Centre Leon Berard
Last refreshed: 8 July 2024

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/NCT04216953.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing