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Trial record 1 of 1 for:    03915405
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KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03915405
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc.

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
Official Title  ICMJE An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
Brief Summary 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).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE
  • Drug: KHK2455
    orally, once daily.
  • Drug: Avelumab
    IV Administration
Study Arms  ICMJE Experimental: KHK2455 in Combination with Avelumab
Interventions:
  • Drug: KHK2455
  • Drug: Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 25, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects may be male or female and must be ≥ 18 years of age; have an ECOG PS of 0 or 1; and a life expectancy of > 3 months in the Investigator's judgment;
  • Subjects are able to understand and willing to sign the ICF, according to institutional standards, prior to the initiation of any study related procedures
  • Subjects must have histological or cytological evidence of metastatic or advanced urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis that has predominantly transitional cell or urothelial features); and have measurable neoplastic disease according to RECIST v1.1 criteria
  • Subjects must have been previously treated with a platinum-based therapy and progressed during or within 12 months of treatment; and be checkpoint-inhibitor naive (not treated with agents targeting PD-1, PD-L1 or CTLA-4)
  • Subjects must have a tumor accessible for fresh biopsy at the baseline visit and for subsequent biopsies during the study for IDO assessment. Archived tissue from previous biopsies (formalin fixed-paraffin embedded [FFPE] block of <12 months) are permitted for PD-L1 analysis
  • Subjects must be able to swallow the solid (encapsulated) dosage form of KHK2455

Exclusion Criteria:

  • Subjects who have been previously treated with avelumab or any IDO1 inhibitor or CTLA-4, PD-1/PD-L1 checkpoint inhibitors; or any investigational immunotherapy including but not limited to anti-cancer vaccines or oncotropic viruses
  • Subjects with prior or current liver metastases;
  • Subjects with a history of organ transplant or allogeneic bone marrow transplant;
  • Subjects with pre-existing uveitis or other known clinically meaningful retinal disorders as determined by a local ophthalmologist
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyowa Kirin Pharmaceutical Development, Inc. 1-609-919-1100 KKD.clinical.info@kyowakirin.com
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915405
Other Study ID Numbers  ICMJE 2455-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Pharmaceutical Development, Inc.
Study Sponsor  ICMJE Kyowa Kirin Pharmaceutical Development, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin Pharmaceutical Development, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP