At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 133 target
Drug / intervention
botensilimab +2 moredrug
Likely dose
FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) 2400mg/m2from record
Key inclusion· 6
- ✓Non-metastatic, newly diagnosed dMMR and pMMR cancers
- ✓Specific tumor types including sarcoma, head and neck cancers, anal cancer, esophageal SCC
- ✓pMMR tumors with no indication for neoadjuvant therapy per standard of care
- ✓Eligible for study biopsy
Key exclusion· 20
- ✕Signs of distant metastases on imaging and physical examination
- ✕Clinical obstruction
- ✕Clinical symptoms or radiological suspicion of perforation
- ✕Previous treatment with immune checkpoint inhibitors including anti-CTLA4 or anti-PD1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
In Brief
A Phase 3 clinical trial evaluating botensilimab, balstilimab, and 1 other intervention for Resectable MMR-deficient Solid Tumors and Resectable MMR-proficient Solid Tumors. Currently recruiting, targeting 133 participants across 1 site.
Detailed Summary
In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
CollaboratorsAgenus Inc.
Timeline
Phase 3Recruiting
20242025202620272028202920302031203220332034
Enrollment StartJan 2024
First PostedFeb 2024
TodayJul 2026
Primary CompletionJan 2029
Study CompletionJan 2034
First PostedFeb 26, 2024
Enrollment StartJan 29, 2024
Primary CompletionJan 29, 2029
Study CompletionJan 29, 2034
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 2.4 years agoPrimary completion in 2.6 years
Interventions
botensilimabdrug
Anti cytotoxic T-lymphocyte associated protein-4 (anti-CTLA4)
balstilimabdrug
Anti programmed cell death protein-1 (anti-PD1)
FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)drug
5-Fluorouracil (2400mg/m2), leucovorin (200mg/m2), oxaliplatin (85mg/m2), docetaxel (50mg/m2).