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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03915405|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : June 10, 2022
|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 a modified 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 :||50 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 :||September 30, 2023|
|Estimated Study Completion Date :||February 28, 2024|
|Experimental: KHK2455 in Combination with Avelumab||
orally, once daily.
Other Name: Bavencio
- 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
|United States, Florida|
|Kyowa Research Site USA001|
|Saint Petersburg, Florida, United States, 33709|
|United States, Iowa|
|Kyowa Research Site USA005|
|Iowa City, Iowa, United States, 52242|
|United States, New Mexico|
|Kyowa Research Site USA006|
|Santa Fe, New Mexico, United States, 87505|
|United States, Texas|
|Kyowa Research Site USA 009|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Kyowa Research Site USA007|
|Milwaukee, Wisconsin, United States, 53226|
|Kyowa Research Site ESP002|
|Barcelona, Spain, 08003|
|Kyowa Research Site ESP003|
|Barcelona, Spain, 08035|
|Kyowa Research Site ESP004|
|Madrid, Spain, 28040|
|Kyowa Research Site ESP001|
|Madrid, Spain, 28050|