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“A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic CArcinoma PaTIents. PECATI”.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508001-25-00
Acronym
MedOPP341
Enrollment
43
Registered
2024-01-08
Start date
2021-03-15
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Metastatic Thymic Carcinoma & B3-thymoma.

Brief summary

Progression free survival (PFS) rate at 5 months, defined as the percentage of patients with B3-Thymoma and TC without disease progression at 5 months after starting the treatment combination.

Detailed description

Response rate (RR) with the treatment combination, Maximum tumor shrinkage with the treatment combination, Disease control rate (DCR) with the treatment combination, Duration of response (DoR) with the treatment combination, Overall survival (OS), Safety and toxicity profile of the combination according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v.5.0).

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGLenvatinib

Sponsors

Medica Scientia Innovation Research S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS) rate at 5 months, defined as the percentage of patients with B3-Thymoma and TC without disease progression at 5 months after starting the treatment combination.

Secondary

MeasureTime frame
Response rate (RR) with the treatment combination, Maximum tumor shrinkage with the treatment combination, Disease control rate (DCR) with the treatment combination, Duration of response (DoR) with the treatment combination, Overall survival (OS), Safety and toxicity profile of the combination according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v.5.0).

Countries

France, Italy, Spain

Outcome results

None listed

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