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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus amurubicin (AMR).
Open, uncontrolled, multi-center, phase II study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab plus amurubicin | Experimental | Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab plus amurubicin | Drug | Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate will be assessed using RECIST ver1.1 by investigators | Imaging will be performed every 6 weeks through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Akamatsu, M.D. | Third Department of Internal Medicine, Wakayama Medical University | Principal Investigator |
| Nobuyuki Katakami, M.D., Ph.D. | Division of Integrated Oncology, Institute of Biomedical Research and Innovation | Principal Investigator |
| Kazuhiko Nakagawa, M.D., Ph.D. | Department of Medical Oncology, Kinki University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wakayama Medical University | Wakayama | 641-8509 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34590034 | Derived | Akamatsu H, Teraoka S, Hayashi H, Fujimoto D, Hayata A, Haratani K, Ozawa Y, Yoshida T, Iwasa T, Shimokawa T, Tomii K, Nakagawa K, Yamamoto N. Pembrolizumab Plus Amrubicin in Patients With Relapsed SCLC: Multi-Institutional, Single-Arm Phase 2 Study. JTO Clin Res Rep. 2021 May 18;2(7):100184. doi: 10.1016/j.jtocrr.2021.100184. eCollection 2021 Jul. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 2, 2021 | |
| Reset | Sep 30, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 2, 2021 | Sep 30, 2021 |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C055866 | amrubicin |
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