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

NCT03915405 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 2455-0022018-003796-35
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 9

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).

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 24 months

Study Arms (1)

KHK2455 in Combination with Avelumab

EXPERIMENTAL

Drug: KHK2455; Drug: Avelumab

Interventions

KHK2455 DRUG

orally, once daily.

KHK2455 in Combination with Avelumab

Avelumab DRUG

IV Administration

Also known as: Bavencio

KHK2455 in Combination with Avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (9)

Kyowa Research Site USA001

St. Petersburg, Florida, 33709, United States

Location

Kyowa Research Site USA005

Iowa City, Iowa, 52242, United States

Location

Kyowa Research Site USA006

Santa Fe, New Mexico, 87505, United States

Location

Kyowa Research Site USA 009

Houston, Texas, 77030, United States

Location

Kyowa Research Site USA007

Milwaukee, Wisconsin, 53226, United States

Location

Kyowa Research Site ESP002

Barcelona, 08003, Spain

Location

Kyowa Research Site ESP003

Barcelona, 08035, Spain

Location

Kyowa Research Site ESP004

Madrid, 28040, Spain

Location

Kyowa Research Site ESP001

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

avelumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 16, 2019
• Study Start: September 26, 2019
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (5); ES (4)