New immunotherapy combo tested before surgery for various cancers
NCT ID NCT06279130
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing two immunotherapy drugs, botensilimab and balstilimab, given before surgery to people with resectable solid tumors that are either mismatch repair deficient (dMMR) or proficient (pMMR). The goal is to see if this combination can shrink tumors significantly, measured by how much viable tumor remains after surgery. About 133 adults with non-metastatic cancers will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- botensilimab and balstilimab (immunotherapy drugs)
- What this could lead to
- If successful, this could show that combining these immunotherapies before surgery helps shrink or eliminate tumors in multiple cancer types, potentially improving outcomes.
- What could go wrong
- This is a mid-stage trial with only 133 participants, and results may not apply to all cancers. Immunotherapies can cause immune-related side effects, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 133 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed written informed consent 2. Patients at least 18 years of age 3. 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) 4. 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; 5. Eligible for study biopsy 6. World health organization (WHO) performance status of 0 or 1 7. Screening laboratory tests must meet the following criteria and should be obtained within 7 days prior to randomization/registration: White blood cell count (WBC \> 2.0 x 10\^9/L, Absolute neutrophil count (ANC) \> 1.5x10\^9/L, platelets \> 100 x 10\^9/L, Hemoglobin \> 5.0mmol/L. Transfusion is allowed to obtain an adequate hemoglobin level. Liver function tests: total bilirubin \< 1.5 upper limit of normal (ULN) (except for subjects with Gilbert syndrome, who can have total bilirubin \<3.0 mg/dL); alkaline phosphatase \<1.5 ULN; transaminases (ASAT/ALAT) \<3 x ULN; Lactate dehydrogenase (LDH) \< 1.5x ULN; Creatinine clearance (Cockcroft-Gault) of \>45 ml/min, Albumin \> 3.0 g/dL 8. Women of childbearing potential (WOCBP)\* must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 20 weeks after the last dose of investigational drug, Non-childbearing potential is defined as: 1. Postmenopausal: ≥ 50 years of age and has not had menses for greater than 1 year. 2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle- stimulating hormone value in the postmenopausal range upon pre-study(screening) evaluation. 3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation. 9. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of cycle 1 day 1 10. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving the study treatment and who are sexually active with WOCBP (excluding azoospermic men) will be instructed to adhere to contraception for a period of 28 weeks after the last dose of investigational drug and are not allowed to donate sperm during that timeframe. Exclusion Criteria: 1. Signs of distant metastases on imaging and physical examination 2. Clinical obstruction 3. Clinical symptoms or radiological suspicion of perforation 4. Previous treatment with immune checkpoint inhibitors including but not limited to anti-CTLA4 or anti-PD1 5. Prior chemotherapy for any cancer 6. Radiotherapy prior to or planned post-surgery radiotherapy for disease under study 7. Active malignancies other than disease under study within 3 years prior to inclusion, except for malignancies with a negligible recurrence rate (e.g. \<10% in 5 years) 8. Allergies and Adverse Drug Reaction: 1. History of allergy to study drug components 2. History of severe hypersensitivity reaction to any monoclonal antibody 9. Intercurrent illnesses, including but not limited to infections, unstable angina pectoris 10. Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity determination of adverse events 11. Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection 12. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) 13. Active autoimmune disease or a documented history of autoimmune disease, or other medical conditions requiring systemic steroid or immunosuppressive medications, except for subjects with vitiligo, diabetes mellitus type 1, hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis or resolved childhood asthma/atopy not requiring systemic treatment 14. Conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease 15. Live vaccines in the 4 weeks prior to inclusion 16. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 17. Current pregnancy or breastfeeding Specific for pMMR GEA cohort: Known DPD deficiency; refer local clinical guidance, for DPD status recommendation prior to starting treatment.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Netherlands Cancer Institute
RECRUITINGAmsterdam, North Holland, 1066 CX, Netherlands