Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06279130

Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations

Led by The Netherlands Cancer Institute · Updated on 2026-03-05

133

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

T

The Netherlands Cancer Institute

Lead Sponsor

A

Agenus Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.

CONDITIONS

Official Title

Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • At least 18 years of age
  • Non-metastatic, newly diagnosed dMMR or pMMR cancers fitting specific baskets or "other" cohort
  • For pMMR tumors: no standard indication for neoadjuvant therapy unless adjuvant treatment is standard
  • Eligible for study biopsy
  • WHO performance status of 0 or 1
  • Screening labs within 7 days prior to registration meeting specified blood counts and organ function levels
  • Women of childbearing potential must use effective contraception during and for 20 weeks after treatment
  • Women of childbearing potential must have a negative pregnancy test within 24 hours before treatment
  • Sexually active men with women of childbearing potential must use highly effective contraception during and for 28 weeks after treatment
  • For pMMR gastroesophageal adenocarcinoma cohort: no known dihydropyrimidine dehydrogenase (DPD) deficiency
Not Eligible

You will not qualify if you...

  • Signs of distant metastases on imaging or physical exam
  • Clinical bowel obstruction
  • Symptoms or suspicion of perforation
  • Prior treatment with immune checkpoint inhibitors including anti-CTLA4 or anti-PD1
  • Previous chemotherapy for any cancer
  • Radiotherapy before or planned after surgery for the study disease
  • Active malignancies other than study disease within 3 years except low recurrence risk cancers
  • Allergy to study drug components or severe reaction to monoclonal antibodies
  • Intercurrent illnesses like infections or unstable angina
  • Medical conditions making study drug administration unsafe or affecting toxicity evaluation
  • Positive tests for hepatitis B surface antigen or hepatitis C RNA
  • History of HIV or AIDS
  • Active or history of autoimmune disease requiring systemic steroids or immunosuppressants except specified conditions
  • Use of systemic corticosteroids >10 mg prednisone equivalent or immunosuppressants within 14 days before study drug
  • Live vaccines within 4 weeks before inclusion
  • Psychological, family, social, or geographic issues affecting study compliance
  • Current pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands, 1066 CX

Actively Recruiting

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Research Team

M

Marieke van de Belt, MsC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

11

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