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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.

Who is the study for?
This trial is for adults with advanced melanoma that didn't respond to checkpoint inhibitor therapy. They must have a life expectancy of at least 3 months, good performance status, and adequate organ function. Participants need confirmed Stage III or IV cutaneous melanoma and may require BRAF V600 mutation testing. Women who can bear children and men with partners who can must use effective birth control.
What is being tested?
The study tests Botensilimab alone or combined with Balstilimab in patients whose melanoma has progressed despite treatment with anti-PD-(L)1 drugs like ipilimumab. It's an open-label Phase 2 trial assessing the effectiveness, safety, tolerability, and how the body processes these drugs.
What are the potential side effects?
Potential side effects include immune-related reactions affecting various organs, infusion-related responses (like allergic reactions during drug administration), fatigue, digestive issues such as nausea or diarrhea, skin rash, hormonal imbalances requiring medication management.

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 3 months) for reporting.

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balstilimab
2023
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,596 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,905 Previous Clinical Trials
8,091,249 Total Patients Enrolled

Media Library

Botensilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05529316 — Phase 2
Skin Cancer Research Study Groups: Part 1 Cohort A: Botensilimab, Part 1 Cohort B: Botensilimab, Part 2 Cohort A: Botensilimab + Balstilimab, Part 2 Cohort B: Botensilimab + Balstilimab
Skin Cancer Clinical Trial 2023: Botensilimab Highlights & Side Effects. Trial Name: NCT05529316 — Phase 2
Botensilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05529316 — Phase 2
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