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Checkpoint Inhibitor

KHK2455 for Bladder Cancer

Phase 1
Waitlist Available
Research Sponsored by Kyowa Kirin, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new combination therapy for bladder cancer.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Investigations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Gastrointestinal disorders
6%
Nervous system disorders
6%
Cardiac disorders
6%
Infections and infestations
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: KHK2455 in Combination with AvelumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KHK2455
2016
Completed Phase 1
~40
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

Kyowa Kirin, Inc.Lead Sponsor
47 Previous Clinical Trials
5,705 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for participants in this trial?

"At this time, no further recruitment is needed for the trial initially posted on September 26th 2019. However, there are 2520 studies seeking patients with carcinoma and 111 trials actively recruiting for KHK2455."

Answered by AI

What sort of unfavorable repercussions have been observed as a result of KHK2455?

"The risk associated with KHK2455 has been assessed as 1 due to its Phase 1 trial status, meaning there is preliminary evidence of efficacy and safety."

Answered by AI

Are there any other research projects that have utilized the KHK2455 compound?

"Back in 2014, KHK2455 was trialled at Port Macquarie Base Hospital. To date, a total of 49 completed trials have taken place with 111 studies actively recruiting patients, the majority being located in Saint Petersburg, Florida."

Answered by AI

How many medical facilities are involved in the implementation of this experiment?

"Patients are being enrolled for this trial at Kyowa Research Site USA001 in Saint Petersburg, Florida; Kyowa Research Site USA006 in Santa Fe, New mexico; and Kyowa Research Site USA005 in Iowa City, Iowa. Additionally, there are 6 more sites associated with the study."

Answered by AI

Is enrollment currently open for this trial?

"Unfortunately, no more participants are being recruited for this particular clinical trial - it was initially announced on September 26th 2019 and last updated June 9th 2022. If you're looking to join other trials, there are currently 2520 open studies available for carcinoma patients and 111 opportunities related to KHK2455."

Answered by AI

Has this experiment been conducted previously or is it a pioneering endeavor?

"The development of KHK2455 has been a global effort. Since its inception in 2014, EMD Serono Research & Development Institute Inc., have supervised 111 active trials across 1024 cities and 52 countries; the original trial included 204 patients and concluded with Phase 2 drug approval. 49 additional trials were conducted since then."

Answered by AI
~3 spots leftby Apr 2025