Your session is about to expire
← Back to Search
Monoclonal Antibodies
Botensilimab for Melanoma
Phase 2
Waitlist Available
Research Sponsored by Agenus 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 from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 3 months)
Awards & highlights
Study Summary
This trial is testing a new drug for people with melanoma that has stopped responding to other treatments.
Eligible Conditions
- Advanced Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 3 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Duration Of Response
Frequency of Treatment-emergent Adverse Events
Overall Survival Time
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part 2 Cohort B: Botensilimab + BalstilimabExperimental Treatment2 Interventions
Participants refractory to PD-(L)1 and CTLA-4 will receive botensilimab IV in combination with balstilimab IV.
Group II: Part 2 Cohort A: Botensilimab + BalstilimabExperimental Treatment2 Interventions
Participants refractory to PD-(L)1 will receive botensilimab IV in combination with balstilimab IV.
Group III: Part 1 Cohort B: BotensilimabExperimental Treatment1 Intervention
Participants refractory to PD-(L)1 and anti-CTLA-4 therapies will receive botensilimab IV.
Group IV: Part 1 Cohort A: BotensilimabExperimental Treatment1 Intervention
Participants refractory to PD-(L)1 therapy will receive botensilimab intravenously (IV).
Find a Location
Who is running the clinical trial?
Agenus Inc.Lead Sponsor
51 Previous Clinical Trials
4,567 Total Patients Enrolled
3 Trials studying Melanoma
350 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorAgenus Inc.
2,777 Previous Clinical Trials
8,063,264 Total Patients Enrolled
35 Trials studying Melanoma
11,084 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.You have a detectable medical condition that can be measured using a specific set of guidelines.You have already received a medication called ipilimumab or tremelimumab for your condition.You have received treatment with anti-PD-(L)1 in the past.You have another type of cancer that requires treatment or had cancer in the past 2 years.If you have received immunotherapy treatment, your last dose should not be more than 12 weeks ago for metastatic cancer or 24 weeks ago for early-stage cancer.You have received treatment with anti-PD-(L)1 before.Your latest medical scan shows that your current cancer treatment is not working anymore.You have received a specific type of immunotherapy called anti-CTLA-4 therapy (such as ipilimumab or tremelimumab) in the past.You have already received a specific type of immunotherapy called anti-CTLA-4 treatment.You are allergic to any of the study drugs or their ingredients.You rely on total parenteral nutrition for your daily nutrition.You have received anti-PD-(L)1 therapy at least 6 weeks ago and your cancer has progressed, based on 2 scans taken 4 weeks apart. If you have symptoms related to your cancer, only 1 scan is needed.You willingly give your written consent before any study-related procedures can begin.You may need to take a test to check for a specific genetic mutation called BRAF V600.You have advanced skin cancer that has spread to other parts of your body, according to a specific system used by doctors to categorize the stage of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Cohort A: Botensilimab
- Group 2: Part 1 Cohort B: Botensilimab
- Group 3: Part 2 Cohort A: Botensilimab + Balstilimab
- Group 4: Part 2 Cohort B: Botensilimab + Balstilimab
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.
Are investigators actively looking for new participants for this research project?
"The clinical trial mentioned is not looking for participants at this time, as of the most recent update on 11/2/2022. This information can be found ClinicalTrials.gov. There are 783 other trials which ARE currently recruiting patients."
Answered by AI
Has Botensilimab received regulatory approval from the FDA?
"Botensilimab is still in Phase 2 clinical trials, so there is not yet enough evidence to support its efficacy. However, there is some data indicating that it is safe, which gives it a score of 2."
Answered by AI
In how many different geographical areas is this trial being conducted?
"There are 7 clinical sites currently participating in this trial. These locations include Scottsdale Healthcare Hospitals DBA HonorHealth in Scottsdale, Virginia K. Crosson Cancer Center at St. Jude Medical Center in Fullerton, and Yale University School of Medicine - Yale Cancer Center in New Haven."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger