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New treatment option for Resectable MMR-deficient Solid Tumors
Official title Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
ClinicalTrials.gov ID: NCT06279130
What this study is testing
What is botensilimab?
botensilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for resectable mmr-deficient solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- In case of pMMR tumors: no indication for neoadjuvant therapy according to standard of care, unless adjuvant treatment is considered a standard of...
- Eligible for study biopsy
You likely can't join if
- 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
- Prior chemotherapy for any cancer
- Radiotherapy prior to or planned post-surgery radiotherapy for disease under study
See the full eligibility criteria
- 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;
- Eligible for study biopsy
- World health organization (WHO) performance status of 0 or 1
- 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) \>...
- 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...
- Postmenopausal: ≥ 50 years of age and has not had menses for greater than 1 year.
- 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.
- Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.
- 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
- 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)...
- 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
- Prior chemotherapy for any cancer
- Radiotherapy prior to or planned post-surgery radiotherapy for disease under study
- 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)
- Allergies and Adverse Drug Reaction:
- History of allergy to study drug components
- History of severe hypersensitivity reaction to any monoclonal antibody
- Intercurrent illnesses, including but not limited to infections, unstable angina pectoris
- 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
- Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
- History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Active autoimmune disease or a documented history of autoimmune disease, or other medical conditions requiring systemic steroid or immunosuppressive medications, except for people with vitiligo, diabetes mellitus type...
- 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...
- Live vaccines in the 4 weeks prior to inclusion
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Current pregnancy or breastfeeding Specific for pMMR GEA cohort: Known DPD deficiency; refer local clinical guidance, for DPD status recommendation prior to starting treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.