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Monoclonal Antibodies
Botensilimab for Skin Cancer
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
No Placebo-Only Group
Summary
This trial is testing botensilimab alone and with balstilimab in adults with advanced skin cancer who haven't responded to other treatments. The drugs aim to help the immune system better recognize and attack cancer cells. The study will see if these treatments are safe and effective.
Eligible Conditions
- Skin Cancer
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate
Secondary study objectives
Duration Of Response
Overall Survival Time
Progression-free Survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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).
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Who is running the clinical trial?
Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,596 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,885 Previous Clinical Trials
8,088,552 Total Patients Enrolled
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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.
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