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Résztvevőt keres itt: Hollandia2. fázis

Pan-tumor neoadjuvant basket study of immune check-point inhibition and novel IO combinations (NEOASIS)

A legfontosabb adatok

Ki végzi
Netherlands Cancer Institute
Hol
Amsterdam (Hollandia)A helyszín megnézése
Állapot
Toboroz
Fázis
2. fázis
Résztvevők
153 fő, tervezett
Kezdés
2024. jan. 26.
Várható befejezés
2030. jan. 31.
A vizsgálat típusa
Beavatkozással járó, 11 csoport
A regiszteradat frissítve
2026. október 21.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek áttétet nem adó daganatuk van, akár mismatch repair hiányos (dMMR), akár nem (pMMR), és műtét előtt immunterápiát kaphatnak.

Életkor
18 éves vagy idősebb
Nem
Mindkét nem
A betegség stádiuma
Áttétet nem adó dMMR vagy pMMR daganat, például vastagbél-, nyelőcső-, gyomor-, méhtest-, mell-, prosztatarák vagy szarkóma.
Korábbi kezelés
Nem kaphatott korábban immun-ellenőrzőpont-gátlót (például CTLA-4, PD-1 vagy PD-L1 elleni szert), nem kaphatott kemoterápiát semmilyen daganatra, és nem kaphatott sugárkezelést az e betegség miatti műtét előtt.
Biomarker vagy leletérték
A daganat dMMR vagy pMMR kell legyen. A pMMR gyomor-, nyelőcső-gyomor átmenet és nyelőcső csoportba nem vehető fel HER-pozitív adenokarcinómás vagy ismert DPD-hiányos beteg.

A részvétel fő kizáró okai

  • Távoli áttét
  • Aktív autoimmun betegség vagy szteroid-/immunszuppresszív kezelés (a felsorolt kivételektől eltekintve)
  • B- vagy C-hepatitis fertőzés, vagy HIV
  • Jelenlegi terhesség vagy szoptatás
  • Klinikai elzáródás vagy átfúródás gyanúja

A regiszter feltételei, szó szerint

Mind a 30 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Specific for pMMR GEA cohort: Known DPD deficiency; refer local clinical guidance, for DPD status recommendation prior to starting 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
  • 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 severe hypersensitivity reaction to any monoclonal antibody
  • 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
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Clinical symptoms or radiological suspicion of perforation
  • History of allergy to study drug components
  • Signs of distant metastases on imaging and physical examination
  • Current pregnancy or breastfeeding
  • Specific for pMMR GEA cohort: no HER-positive adenocarcinoma
  • Clinical obstruction

Helyszínek itt: Hollandia

  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, HollandiaRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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. Efficacy outcome used here is major pathologic response rate, defined as ≤ 10% viable tumor remaining in surgical resection of tumor bed following neoadjuvant therapy.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 11 csoportja

  • Cohort 2: pMMR Safety run-in 1 - closed (accrual reached)A vizsgált kezelés

    5 Patients will be included and will be treated with 2 cycles of neoadjuvant immunotherapy consisting of 450mg balstilimab and 25mg botensilimab in Cycle 1 and 450mg balstilimab in Cycle 2 followed by surgery Accrual was reached in June 2024, cohort is closed.

    Kezelés: botensilimab és balstilimab

  • Cohort 4: pMMR Safety run-in 2 - closed (accrual reached)A vizsgált kezelés

    5 Patients will be included and will be treated with 2 cycles of neoadjuvant immunotherapy consisting of 450mg balstilimab and 50mg botensilimab in Cycle 1 and 450mg balstilimab in Cycle 2 followed by surgery Accrual was reached in August 2024, cohort is closed.

    Kezelés: botensilimab és balstilimab

  • Cohort 1: dMMR Safety run-in 1 - closed (accrual reached)A vizsgált kezelés

    5 Patients will be included and will be treated with 2 cycles of neoadjuvant immunotherapy consisting of 450mg balstilimab and 25mg botensilimab in Cycle 1 and 450mg balstilimab in Cycle 2 followed by surgery Accrual was reached in June 2025, cohort is closed.

    Kezelés: botensilimab és balstilimab

  • Cohort 3: dMMR Safety run-in 2 - closed (accrual reached)A vizsgált kezelés

    5 Patients will be included and will be treated with 2 cycles of neoadjuvant immunotherapy consisting of 450mg balstilimab and 50mg botensilimab in Cycle 1 and 450mg balstilimab in Cycle 2 followed by surgery Acrrual was reached in August 2024, cohort is closed.

    Kezelés: botensilimab és balstilimab

  • Cohort 6: dMMR Colorectal basket - closed (accrual reached)A vizsgált kezelés

    Patients with resectable colon and rectal cancer will be treated with the regimen assesses as safe and feasible in the dMMR safety run-in. Treatment will be administered at day 1 and day 22 followed by surgery 8 weeks after registration. Accrual will be temporarily halted after accrual of the first 8 patients. If \>2 major pathological responses are observed accrual will continue to a total of 18 patients. Accrual was reached in July 2025, cohort is closed.

    Kezelés: botensilimab és balstilimab

  • Cohort 5: dMMR Upper gastro-intestinal cancer basketA vizsgált kezelés

    Patients with resectable oesophageal (adenocarcinoma), gastro-oesophageal junction, gastric and small bowel cancer will be treated with the regimen assessed as safe and feasible in the dMMR safety run-in. Treatment will be administered at day 1 and day 22 followed by surgery 8 weeks after registration. Accrual will be temporarily halted after accrual of the first 8 patients. If \>2 major pathological responses are observed accrual will continue to a total of 18 patients.

    Kezelés: botensilimab és balstilimab

  • Cohort 7: dMMR "other cancers" basketA vizsgált kezelés

    Patients with resectable solid tumors of various origins such as but not limited to breast-, prostate-, bladder cancer, Head\&Neck SCC, oesophageal SCC and sarcoma will be treated with the regimen assessed as safe and feasible in the dMMR safety run-in. Treatment will be administered at day 1 and day 22 followed by surgery 8 weeks after registration. Accrual will be temporarily halted after accrual of the first 8 patients. If \>2 major pathological responses are observed accrual will continue to a total of 18 patients.

    Kezelés: botensilimab és balstilimab

  • Cohort 8: pMMR TNBC cohortA vizsgált kezelés

    Patients with resectable Triple Negative Breast Cancer will be treated with the regimen assessed as safe and feasible in the pMMR safety run-in. Treatment will be administered at day 1 and day 22 followed by surgery 8 weeks after registration. Accrual will be temporarily halted after accrual of the first 8 patients. If \>2 major pathological responses are observed accrual will continue to a total of 18 patients.

    Kezelés: botensilimab és balstilimab

  • Cohort 9: pMMR "other cancers" - cohort closedA vizsgált kezelés

    Patients with resectable pMMR tumors of various origins will be treated with the regimen assessed as safe and feasible in the pMMR safety run-in. Treatment will be administered at day 1 and day 22 followed by surgery 8 weeks after registration. Accrual will be temporarily halted after accrual of the first 8 patients. If \>2 major pathological responses are observed accrual will continue to a total of 18 patients. Accrual was halted after 8 patients in July 2025, not more then 2 major pathological responses were observed, cohort remains closed.

    Kezelés: botensilimab és balstilimab

  • Cohort 10: pMMR GEA basketA vizsgált kezelés

    Patients with pMMR gastro-, esophageal or GE-junction tumors will receive study treatment that consists of cycle 1) botensilimab 50mg plus balstilimab 240mg 2) FLOT + bal 240mg 3) FLOT plus bot 50mg/bal 240mg 4-5) FLOT + bal 240mg. Surgery will take place a maximum of 6 weeks after start last treatment cycle. Patients will receive 8mg dexamethasone as premedication for docetaxel on the first day of infusion, and no additional doses of dexamethasone are allowed in the following days as an anti-emetic. Post-surgery, patients may receive 4 additional cycles of FLOT according to the standard of care. Evaluation will be performed after the first 3 patients are treated; if the proposed treatment is deemed feasible and all patients received the intended chemotherapy regimen, accrual may continue with the next 3 patients. If the first three patients undergo surgery according to plan without delays that are considered immune-related, accrual may continue beyond six patients (max 21).

    Kezelés: botensilimab, balstilimab és FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)

  • Cohort 11: dMMR Rectal Organ Preservation basketA vizsgált kezelés

    Patients with stage I-III dMMR rectal adenocarcinoma who prefer organ preservation are eligible. The study treatment will consist of 1 cycle of combination therapy on day 1: botensilimab 50mg plus balstilimab 450mg, followed by 2 cycles of balstilimab 450mg monotherapy on day 22 and day 43. If at the 1st response evaluation at 10 weeks a limited response, no response or progressive disease is observed, treatment according to standard of care, which may consist of direct surgery or additional neoadjuvant therapy may be considered after discussion in the MDT and with the study team.

    Kezelés: botensilimab és balstilimab

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 9.
A regiszteradat frissítve
2026. október 21.