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KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer

Primary Purpose

Urothelial Carcinoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
KHK2455
Avelumab
Sponsored by
Kyowa Kirin, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; OR Been previously treated with platinum based adjuvant or neo-adjuvant therapy and relapsed or progressed; OR
  • Be platinum-based chemotherapy intolerant or ineligible; OR
  • Have progressed during or after treatment with approved PD-1/PD-L1 inhibitors
  • Subjects must have a tumor accessible for fresh biopsy at the baseline visit and for IDO assessment. If current circumstances prohibit the biopsy procedure (e.g., temporary hospital protocol restrictions, regulatory or local authority requirements, etc.) then archived tissue from previous biopsies (fresh frozen tissue < 9 months and formalin fixed-paraffin embedded [FFPE] block of ≤ 24 months) without intervening checkpoint inhibitors can substitute for a fresh baseline biopsy;
  • 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

Sites / Locations

  • Kyowa Research Site USA001
  • Kyowa Research Site USA005
  • Kyowa Research Site USA006
  • Kyowa Research Site USA 009
  • Kyowa Research Site USA007
  • Kyowa Research Site ESP002
  • Kyowa Research Site ESP003
  • Kyowa Research Site ESP004
  • Kyowa Research Site ESP001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KHK2455 in Combination with Avelumab

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
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).

Secondary Outcome Measures

Full Information

First Posted
March 19, 2019
Last Updated
October 2, 2023
Sponsor
Kyowa Kirin, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03915405
Brief Title
KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
Official Title
An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Termination was based on the business decision
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK2455 in Combination with Avelumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK2455
Intervention Description
orally, once daily.
Intervention Type
Drug
Intervention Name(s)
Avelumab
Other Intervention Name(s)
Bavencio
Intervention Description
IV Administration
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
Description
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).
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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; OR Been previously treated with platinum based adjuvant or neo-adjuvant therapy and relapsed or progressed; OR Be platinum-based chemotherapy intolerant or ineligible; OR Have progressed during or after treatment with approved PD-1/PD-L1 inhibitors Subjects must have a tumor accessible for fresh biopsy at the baseline visit and for IDO assessment. If current circumstances prohibit the biopsy procedure (e.g., temporary hospital protocol restrictions, regulatory or local authority requirements, etc.) then archived tissue from previous biopsies (fresh frozen tissue < 9 months and formalin fixed-paraffin embedded [FFPE] block of ≤ 24 months) without intervening checkpoint inhibitors can substitute for a fresh baseline biopsy; 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
Facility Information:
Facility Name
Kyowa Research Site USA001
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Kyowa Research Site USA005
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kyowa Research Site USA006
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Kyowa Research Site USA 009
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kyowa Research Site USA007
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Kyowa Research Site ESP002
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Kyowa Research Site ESP003
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Kyowa Research Site ESP004
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Kyowa Research Site ESP001
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

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KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer

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