PREDOSTAR - PREventing second cancers with DOSTARlimab - A multicenter, open-label, randomized phase II study aiming to assess the clinical impact of dostarlimab on occurrence of second primary cancer in patients with cured primary cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501316-34-00

Acronym

PREDOSTAR/ET22-215

Enrollment

400

Registered

2023-03-21

Start date

2023-11-27

Completion date

Unknown

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient cured from a primary cancer and at risk of 2nd cancer

Brief summary

Incidence of SPC in patients who have completed curative treatment for a FPC., Second primary invasive cancer must be histologically confirmed and classified according to International Classification of Diseases for Oncology (https://www.who.int/classifications/icd/adaptations/oncology/en/) and IARC rules (REF).

Detailed description

 Rate of SPC at 3 years  Time to SPC  Event Free survival  Overall Survival since randomisation and since SPC  Recurrence of FPC,  AE/SAE according to NCI-CTCAE V5.0

Interventions

DRUGJEMPERLI 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of SPC in patients who have completed curative treatment for a FPC., Second primary invasive cancer must be histologically confirmed and classified according to International Classification of Diseases for Oncology (https://www.who.int/classifications/icd/adaptations/oncology/en/) and IARC rules (REF).	—

Secondary

Measure	Time frame
 Rate of SPC at 3 years  Time to SPC  Event Free survival  Overall Survival since randomisation and since SPC  Recurrence of FPC,  AE/SAE according to NCI-CTCAE V5.0	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026