NCT06279130

Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 133 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.

Detailed description

The NEOASIS study is an adaptive, pan-cancer, single-center, open-label, basket study assessing the efficacy of botensilimab and balstilimab in patients with resectable dMMR and pMMR solid tumors of various origins. Patients will be included in baskets according to tumor type and mismatch repair (MMR) status and will receive 2 cycles of immunotherapy followed by surgery. The trial will commence with two safety run-in cohorts: one for patients with dMMR tumors and one for patients with pMMR tumors that will run in parallel. These safety run-in cohort will be used to assess safety and feasibility of pre-operative botensilimab + balstilimab. Data from the safety run-in cohorts will be used to determine the dosing and scheduling to be used in the MMR-specific cohorts of the main study. Safety will be assessed according to dose limiting toxicities. In the run-in cohorts, the first five patients will receive botensilimab 25mg intravenously (IV) on Day1 plus balstilimab 450mg IV on Day1 and Day22. Patients 6-10 will receive botensilimab 50mg IV on Day1 plus balstilimab 450mg IV on Day1 and Day22 followed by surgery 8 weeks after registration. After full accrual of the run-in cohorts, MMR-specific baskets including a "other cancers" basket will start accrual with the optimal dose and schedule as determined in the safety run-in followed by surgery 8 weeks after registration. The MMR-specific baskets are designed with a Simon's 2 stage design in which first 8 patients will be included, if in the first 8 patients \>2 Major pathological responses are reported (defined as ≤10% residual viable tumor) accrual of 10 more patients will continue for a total of 18 patients per basket. This study was amended (approved in December 2025) to add cohort 10 and cohort 11. In cohort 10, patients with pMMR GEA tumors will receive Botensilimab and Balstilimab in combination with FLOT. In cohort 11, patients with dMMR rectum tumors will receive Botensilimab and Balstilimab. We aim for organ preservation in this cohort. See "Arms and Interventions" for more.

Conditions

• Resectable MMR-deficient Solid Tumors
• Resectable MMR-proficient Solid Tumors

Interventions

Type	Name	Description
DRUG	botensilimab	Anti cytotoxic T-lymphocyte associated protein-4 (anti-CTLA4)
DRUG	balstilimab	Anti programmed cell death protein-1 (anti-PD1)
DRUG	FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)	5-Fluorouracil (2400mg/m2), leucovorin (200mg/m2), oxaliplatin (85mg/m2), docetaxel (50mg/m2).

Timeline

• Start date: 2024-01-29
• Primary completion: 2029-01-29
• Completion: 2034-01-29
• First posted: 2024-02-26
• Last updated: 2026-03-05

Locations

1 site across 1 country: Netherlands