Study Summary
This trial is studying pembrolizumab and sunitinib malate to treat thymic cancer.
Eligible Conditions
- Thymic Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Up to 24 months
Month 24
Overall survival (OS)
Progression free survival (PFS)
Up to 24 months
PD-L1 by immunohistochemistry
Response defined by a complete response (CR) or partial response (PR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Day 30
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Treatment (pembrolizumab, sunitinib malate)
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Treatment (pembrolizumab, sunitinib malate)Experimental Group · 3 Interventions: Pembrolizumab, Sunitinib Malate, Laboratory Biomarker Analysis · Intervention Types: Biological, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Sunitinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,089 Previous Clinical Trials
41,142,240 Total Patients Enrolled
9 Trials studying Thymic Carcinoma
793 Patients Enrolled for Thymic Carcinoma
Dwight OwenLead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled
Dwight Owen, MDPrincipal Investigator - Ohio State University Comprehensive Cancer Center
OSU Harding Hospital, Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Remon, Jordi, Nicolas Girard, Silvia Novello, Javier de Castro, Laurence Bigay-Game, Reyes Bernabé, Laurent Greillier, et al.. 2022. “PECATI: A Multicentric, Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-thymoma and Thymic Carcinoma Patients”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2021.07.008.
- Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20.
- Dwight Owen 2018. "Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03463460.
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Conditions
Cancer Related
Treatments