KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03915405|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: KHK2455 Drug: Avelumab||Phase 1|
This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis). Subjects will be screened for entry into this study after signing informed consent. Subjects must meet inclusion/exclusion criteria to participate in this study.
- Part 1 (dose-escalation phase) has has a 3+3 design that will evaluate the safety and tolerability and identify the MTD or highest protocol-defined dose, in the absence of exceeding the MTD.
- Part 2 (cohort-expansion phase) will further explore the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity for the combination regimen at the MTD or highest dose level tested.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma|
|Actual Study Start Date :||September 26, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||February 25, 2022|
|Experimental: KHK2455 in Combination with Avelumab||
orally, once daily.
- Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 [ Time Frame: up to 24 months ]To characterize the safety and tolerability of KHK2455 administered in combination with avelumab in subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).
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): NCT03915405
|Contact: Kyowa Kirin Pharmaceutical Development, Inc.||1-609-919-1100||KKD.firstname.lastname@example.org|
|United States, Arizona|
|Kyowa Research Site USA004||Recruiting|
|Gilbert, Arizona, United States, 85234|
|United States, Florida|
|Kyowa Research Site USA001||Recruiting|
|Saint Petersburg, Florida, United States, 33709|
|United States, Iowa|
|Kyowa Research Site USA005||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Kyowa Research Site ESP002||Recruiting|
|Barcelona, Spain, 08003|
|Kyowa Research Site ESP003||Recruiting|
|Barcelona, Spain, 08035|
|Kyowa Research Site ESP004||Recruiting|
|Madrid, Spain, 28040|
|Kyowa Research Site ESP001||Recruiting|
|Madrid, Spain, 28050|