Special Combination of OBP-301 and Pembrolizumab
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|ClinicalTrials.gov Identifier: NCT03172819|
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Biological: OBP-301 Drug: Pembrolizumab||Phase 1|
Phase 1a part:
To evaluate safety and tolerability in combination of OBP-301 and Pembrolizumab in patient with advanced or metastatic solid tumor and to determine recommended dose in phase 1b part.
Phase 1b part:
To evaluate safety and potential efficacy in combination of OBP-301 and Pembrolizumab in patients in expanded arm.
|Study Type :||Interventional|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 With Pembrolizumab in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||January 2021|
Intratumoral injection directly into the dose target region of a tumor at Day 1, Day 15, and Day 29.
Additional administration of OBP-301 After the recommended dose of OBP-301 has been established, additional administration of OBP-301 is allowed. After completion of administration of OBP-301 on Day 1 - Day 29(+/- 4 days), if the target region has not disappeared, additional administration of OBP-301 is allowed after Day 43 or later.
The patients in Phase 1a, Pembrolizumab administration has continued, are included.
The recommended dose determined in the Phase 1a part will be administered 3 times biweekly (+/- 4 days); max 4 cycles.
200 mg Pembrolizumab is infused intravenously at Day 8. Thereafter infusion will continue every 3 weeks until discontinuation.
- Dose limiting toxicity (DLT) [ Time Frame: 4weeks ]Dose limiting toxicity
- Response rate (RR) [ Time Frame: 3 years ]Response rate by RECIST ver. 1.1
- Progression free survival (PFS) [ Time Frame: 3 years ]Progression free survival
- Rate of adverse event [ Time Frame: 3 years ]Rate of adverse event
- Biomarkers:Efficacy evaluations according to immune status [ Time Frame: 3 years ]Immune status will be analyzed using biopsy and blood samples by flow cytometry, RNA seq, whole exome sequencing, and immunohistochemistry, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172819
|Contact: Takashi Kojima, Dr||+81-4-7133-1111 ext 91266||OBPem_core@east.ncc.go.jp|
|National Cancer Center Hospital East||Recruiting|
|Kashiwa, Chiba, Japan|
|Contact: Takashi Kojima, Dr +81-4-7133-1111 ext 91266 OBPem_core@east.ncc.go.jp|
|Study Chair:||Toshihiko Doi, Dr||National Cancer Center Hospital East|