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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
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc.

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).

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: KHK2455 Drug: Avelumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: KHK2455 in Combination with Avelumab Drug: KHK2455
orally, once daily.

Drug: Avelumab
IV Administration




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kyowa Kirin Pharmaceutical Development, Inc. 1-609-919-1100 KKD.clinical.info@kyowakirin.com

Locations
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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
Spain
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
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
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Responsible Party: Kyowa Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier: NCT03915405    
Other Study ID Numbers: 2455-002
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms