Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.
Eligibility criteria
Qualifiers
Signed written informed consent
Patients at least 18 years of age
Non-metastatic, newly diagnosed dMMR and pMMR cancers either fitting within a specific basket or in the "other" cohort (e.g. sarcoma, head and neck cancers, anal cancer, esophageal SCC)
In case of pMMR tumors: no indication for neoadjuvant therapy according to standard of care, unless adjuvant treatment is considered a standard of care alternative;
Disqualifiers
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 but not limited to anti-CTLA4 or anti-PD1
Trial design
Treatments tested in this trial
- botensilimab
- balstilimab
- FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)
Treatment groups
133 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Agenus Inc.
Collaborator
Source ClinicalTrials.gov