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Pan-tumor neoadjuvant basket study of immune check-point inhibition and novel IO combinations (NEOASIS)
EU CTIS ID: 2023-505756-21-00
What this study is testing
Primary objective for pMMR GEA cohort/basket: to determine the efficacy of priming with botensilimab + balstilimab followed by a combination of FLOT chemotherapy with balstilimab/ botensilimab. Efficacy outcome used here is major pathologic response rate, defined as ≤ 10% viable tumor remaining in surgical resection of tumor bed following neoadjuvant therapy. Primary objective for dMMR rectal cancer OP cohort/basket: to determine the efficacy of botensilimab + balstilimab in dMMR RC. Efficacy outcome used is near-cCR and cCR rate at the second response evaluation. Primary objective for dMMR cohorts/baskets: To determine efficacy of botensilimab + balstilimab in dMMR tumors, as determined per basket. Efficacy outcome used here is major pathologic response rate, defined as ≤ 10% viable tumor remaining in surgical resection of tumor bed following neoadjuvant therapy Primary objective for pMMR cohorts/baskets: to determine efficacy of botensilimab + balstilimab in pMMR tumors, as determined per basket. . Efficacy outcome used here is major pathologic response rate, defined as ≤ 10% viable tumor remaining in surgical resection of tumor bed following neoadjuvant therapy Primary Objective Safety run-in cohort #1: dMMR tumors (n=10): To determine the safety and feasibility of pre-operative bot + bal in dMMR tumors of any origin. Primary Objective Safety run-in cohort #2: pMMR tumors (n=10): To determine the safety and feasibility of pre-operative bot + bal in pMMR tumors of any origin.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent
- 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
- Patients at least 18 years of age
- Non-metastatic dMMR and pMMR cancers either fitting within a specific basket or in the “other” cohort (e.g. sarcoma, cervical cancer, head and neck cancers, anal cancer, esophageal SCC)
- Eligible for study biopsy
- WHO performance status of 0 or 1
You likely can't join if
- Signs of distant metastases on imaging and physical examination
- Current pregnancy or breastfeeding
- Clinical obstruction
- Clinical symptoms or radiological suspicion of perforation
- Previous treatment with immune checkpoint inhibitors targeting including but not limited to CTLA-4, PD-1 or PD-L1
- Prior chemotherapy for any cancer
See the full eligibility criteria
- Signed written informed consent
- 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
- Patients at least 18 years of age
- Non-metastatic dMMR and pMMR cancers either fitting within a specific basket or in the “other” cohort (e.g. sarcoma, cervical cancer, head and neck cancers, anal cancer, esophageal SCC)
- Eligible for study biopsy
- 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: WBC > 2.0 x 10^9/L, 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 <1.5ULN; transaminases (ASAT/ALAT) <3 x ULN; LDH < 1.5x ULN; Creatinine clearance (Cockcroft-Gault) of >45 ml/min, Albumin > 3.0 g/dL
- 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: a. Postmenopausal: ≥ 50 years of age and has not had menses for greater than 1 year. b. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and afollicle-stimulating hormone value in the postmenopausal range upon prestudy( screening) evaluation. c. 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 7 days prior to registration
- 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.
- Signs of distant metastases on imaging and physical examination
- Current pregnancy or breastfeeding
- Clinical obstruction
- Clinical symptoms or radiological suspicion of perforation
- Previous treatment with immune checkpoint inhibitors targeting including but not limited to CTLA-4, PD-1 or PD-L1
- Prior chemotherapy for any cancer
- Radiotherapy prior to surgery 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);
- History of allergy to study drug components
- History of severe hypersensitivity reaction to any monoclonal antibody
- Specific for pMMR GEA cohort: Known DPD deficiency; refer local clinical guidance, for DPD status recommendation prior to starting treatment
- No 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 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
- 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
- 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
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.