Your session is about to expire
← Back to Search
Other
Combination Therapies for Bladder Cancer (Optimus Trial)
Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage T2-T3b, N0, M0 muscle invasive urothelial carcinoma by CT (or MRI) (Stage II-IIIA per AJCC 2018).
Eligible for radical cystectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Optimus Trial Summary
This trial is testing different combinations of neoadjuvant treatments for people with bladder cancer who can't or won't have cisplatin therapy.
Who is the study for?
This trial is for adults with muscle-invasive bladder cancer who can't have or don't want cisplatin therapy and are set for radical cystectomy. They should be mostly healthy (ECOG 0-1), not have had cancer treatments, or other recent medical interventions, and agree to contraception.Check my eligibility
What is being tested?
The study tests different neoadjuvant treatment combinations including INCAGN02390, retifanlimab, INCAGN02385, epacadostat before surgery in patients refusing or ineligible for cisplatin. It's a Phase 2 trial where participants are randomly assigned to various treatment groups.See study design
What are the potential side effects?
Potential side effects may include immune system reactions that could affect organs, infusion-related responses like fever or chills, fatigue, digestive issues such as nausea or diarrhea, increased risk of infections due to lowered immunity.
Optimus Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is at a stage where it's grown into the muscle but hasn't spread to lymph nodes or other parts of my body.
Select...
I am a candidate for major bladder surgery.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My biopsy sample is large enough and has enough cancer cells for testing.
Optimus Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunologic intratumoral changes
Secondary outcome measures
Major pathological response
Number of Treatment Emergent Adverse Events (TEAE)
pathological complete response
Optimus Trial Design
5Treatment groups
Experimental Treatment
Group I: Treatment Group EExperimental Treatment3 Interventions
retifanlimab will be administered in combination with INCAGN02385 and INCAGN02390.
Group II: Treatment Group DExperimental Treatment2 Interventions
retifanlimab will be administered in combination with INCAGN02385.
Group III: Treatment Group CExperimental Treatment1 Intervention
epacadostat will be administered as monotherapy.
Group IV: Treatment Group BExperimental Treatment1 Intervention
retifanlimab will be administered as monotherapy.
Group V: Treatment Group AExperimental Treatment2 Interventions
epacadostat will be administered in combination with retifanlimab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCAGN02390
2018
Completed Phase 1
~40
retifanlimab
2018
Completed Phase 1
~30
INCAGN02385
2018
Completed Phase 1
~30
epacadostat
2018
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,135 Total Patients Enrolled
Diane Hershock, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread and can be measured.I take more than 10 mg/day of prednisone or equivalent for an autoimmune disease.You have experienced serotonin syndrome after taking medications that affect serotonin in the past.I have active hepatitis B, hepatitis C, or HIV.I am not taking medications that are sensitive to certain liver enzymes.I have had cancer other than miUBC that is not getting worse or needing treatment, or I had another cancer but it was over 2 years ago.My biopsy sample is large enough and has enough cancer cells for testing.I still experience significant side effects from my past treatments or surgeries.I have heart problems that affect my daily activities.I am not on any other cancer treatments.I have not had major surgery in the last 4 weeks.I have an autoimmune disease and have been on high-dose steroids or immunosuppressants within the last 2 years.I haven't needed antibiotics for an infection in the last 2 weeks.I am not taking any medications that are not allowed in this study.I have had a transplant of tissue or an organ from another person.I have a lung condition not caused by an infection.I am taking or need to take drugs that are UGT1A9 inhibitors.I am a candidate for major bladder surgery.I am fully active or restricted in physically strenuous activity but can do light work.I have cancer cells in the fluid around my brain and spinal cord.I currently have or might have an active COVID-19 infection.My bladder cancer is mostly transitional cell type.I cannot or choose not to receive cisplatin therapy.My bladder cancer is at a stage where it's grown into the muscle but hasn't spread to lymph nodes or other parts of my body.I have experienced significant side effects from previous immunotherapy.I have a gut condition that could affect how I absorb pills.I have had treatment for bladder cancer or received immunotherapy.I have not received a live vaccine in the last 30 days.I have not taken probiotics in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group A
- Group 2: Treatment Group C
- Group 3: Treatment Group B
- Group 4: Treatment Group E
- Group 5: Treatment Group D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has retifanlimab been tested in previous medical studies?
"Currently, 35 retifanlimab trials are ongoing. Five of these have progressed to the third stage of clinical research and many more sites than just Istanbul and California are hosting such studies - 1045 in total, to be precise."
Answered by AI
How many volunteers are engaged in this research?
"Affirmative, the clinicaltrials.gov website indicates that this medical trial is still in its recruitment phase. First posted on January 14th 2022 and updated as recently as November 15th 2022, 45 patients are required to be enrolled at 3 different centres."
Answered by AI
Is the recruitment phase of this research still open?
"Affirmative. Information available on clinicaltrials.gov confirms that this medical experiment, initially announced on January 14th 2022, is actively enrolling participants. 45 patients will be recruited from 3 different sites for the study."
Answered by AI
Has retifanlimab been granted regulatory authorization by the FDA?
"While there is evidence of safety, the lack of efficacy data for retifanlimab resulted in a score of 2."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger