NCT05855811 (PREDOSTAR) is a Phase 2 clinical trial of Dostarlimab in Recurrent Cancer, sponsored by Centre Leon Berard.

Who is sponsoring NCT05855811?

NCT05855811 is sponsored by Centre Leon Berard.

What drugs are being tested in NCT05855811?

Interventions in NCT05855811: Dostarlimab.

What condition does NCT05855811 study?

NCT05855811 studies Recurrent Cancer, Primary Cancer, Second Cancer.

Is NCT05855811 still recruiting?

NCT05855811 is currently recruiting now. Last updated 15 July 2024.

Last reviewed 2024-07-15 · How we verify

NCT05855811: PREDOSTAR

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

PREventing Second Cancers With DOSTARlimab

Recruiting now Phase 2 Last updated 15 July 2024

What this trial tests

Phase 2 trial testing Dostarlimab in Recurrent Cancer in 400 participants. Currently enrolling.

Timeline

26 July 2023

Primary endpoint
26 July 2028

26 March 2029

Quick facts

Lead sponsor	Centre Leon Berard
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	400
Start date	26 July 2023
Primary completion	26 July 2028
Estimated completion	26 March 2029
Sites	5 locations across France

Drugs / interventions tested

Dostarlimab (DOSTARLIMAB) — full drug profile →

Conditions studied

Recurrent Cancer — all drugs for Recurrent Cancer →
Primary Cancer — all drugs for Primary Cancer →
Second Cancer — all drugs for Second Cancer →

Sponsor

Centre Leon Berard — full company profile →

Who can join

18 and older, any sex, with Recurrent Cancer or Primary Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PredoSTAR is a multicenter, randomized, open-label phase II study proposed to patients at high risk of SPC and in whom the treatment of the FPC does not include immunotherapy. Dostarlimab treatment will be started within 6 months after the completion of treatment for localized FPC (i.e. after the end of last CT, RT cure or surgery with a wash-out period of 4 weeks before to start Dostarlimab). Eligible patients will be randomized (1:1) to receive: * Arm Dostarlimab : 4 intravenous (IV) injections of dostarlimab, Q3W or * Arm No treatment

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Impact of Immune Checkpoint Inhibitors on Second Primary Cancer Risk in Patients With Metastatic Lung Cancer Using Real-World Data From the TriNetX Network: Retrospective Cohort Study.
Heudel P, Hernandez G, Denquin O, Crochet H, et al · · 2025 · PMID 41118671 · DOI 10.2196/64900

Verify or expand the search:

Other trials of Dostarlimab

Trials testing the same drug.

NCT07408063 — A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Res · Phase 2 · not yet recruiting
NCT07381777 — XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Lo · Phase 2 · not yet recruiting
NCT06405230 — Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Or · Phase 1, PHASE2 · recruiting
NCT07336147 — Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine · Phase 2 · recruiting
NCT07108270 — A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recur · Phase 2 · recruiting

Other recruiting trials for Recurrent Cancer

Currently open trials in the same condition.

NCT06644846 — Spatially Fractionated Radiation Treatment for Gynaecological Cancers · NA · recruiting
NCT05189054 — Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors · recruiting
NCT05043922 — A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma · Phase 2 · active not recruiting
NCT04204850 — Cabozantinib to Treat Recurrent Liver Cancer Post Transplant · Phase 2 · recruiting
NCT04421560 — Pembrolizumab, Ibrutinib and Rituximab in PCNSL · Phase 1, PHASE2 · 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 NCT05855811 (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: 15 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/NCT05855811.

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