NCT04554524

Chemotherapy Combined With Pembrolizumab in Treating Patients With Thymoma and Thymic Carcinoma

Single-Arm Study to Carbo-paclitaxel/ Nab-paclitaxel Combined With Pembrolizumab as the First Line Therapy in Treating Patients With Locally Advanced or Metastatic Invasive Thymoma and Thymic Carcinoma That Cannot Be Removed by Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigational, single arm study.

Detailed description

Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use chemotherapy combined with pembrolizumab to treat thymoma or Thymic carcinoma. Subjects will be evaluated for eligibility during a 28-day screening period. Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Up to 40 participants will be enrolled in this study.

Conditions

• Thymoma and Thymic Carcinoma

Interventions

Type	Name	Description
DRUG	Chemotherapy+Pembrolizumab.	Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). After 4 cycles treatment, complete response subjects continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, some of partial disease and stable disease subjects can receive surgical treatment. And then continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, other partial disease and stable disease subjects cannot be removed by surgery will continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab for 4 cycles and then pembrolizumab or Normal Saline up to disease progression.

Timeline

• Start date: 2020-08-27
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2020-09-18
• Last updated: 2020-10-28

Locations

1 site across 1 country: China