Actively Recruiting
Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-08-02
25
Participants Needed
8
Research Sites
417 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
To investigate the effects of the combination of two chemotherapies followed by immunostimulants on the interferon gamma expression and infiltration of cytotoxic T cells in the tumour microenvironment in patients with previously untreated metastatic or locally advanced esophagogastric cancer.
CONDITIONS
Official Title
Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Age 18 years or older
- Histologically confirmed metastatic or irresectable HER2 negative adenocarcinoma of the stomach or gastroesophageal junction (Siewert II and III); HER2 positive patients eligible if trastuzumab is contraindicated
- No prior chemotherapy or radiotherapy for metastatic or irresectable disease
- Measurable disease according to RECIST 1.1
- dMMR confirmed by immunohistochemistry of mismatch repair proteins MLH1, PMS2, MSH2, and MSH6
- Accessible primary tumor or metastasis for fresh biopsies
- ECOG performance status 0-2
- Adequate bone marrow and organ function based on lab values
- Negative pregnancy test for women of child-bearing potential and agreement to use contraception
- No conditions hindering compliance with study protocol and follow-up
You will not qualify if you...
- Severe renal impairment (creatinine clearance ≤ 30 ml/min)
- Clinically significant disorders negatively impacting risk-benefit balance
- Prior anti-cancer chemotherapy, biologic, or investigational therapy for metastatic or irresectable stomach or esophageal cancer
- Disease progression within 6 months after completing (neo)adjuvant chemotherapy containing fluoropyrimidine and/or platinum compounds (except specific allowed neoadjuvant chemoradiation)
- All target lesions in a radiation field without documented progression
- Known brain metastases unless well-controlled for at least 3 months
- Past or current malignancy other than entry diagnosis affecting prognosis
- Known hypersensitivity or contraindications to study drugs
- Complete dihydropyrimidine dehydrogenase deficiency
- Active, uncontrolled infections requiring systemic therapy
- Known HIV, hepatitis B or C infection
- Signs of interstitial lung disease
- Active or suspected autoimmune disease, except certain controlled conditions
- Other severe or uncontrolled medical conditions contraindicating participation
- Use of other investigational drugs within 30 days
- Enrollment in other clinical trials interfering with study endpoints
- Unwillingness or inability to comply with study requirements
- Pregnancy, breastfeeding, or unwillingness to use reliable contraception
- Recent treatment with DPD inhibitors
- Pre-existing motor or sensory neurotoxicity grade >1
- History of organ transplant
- Use of probiotics at first dose of study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Academic Medical Center, Medical Oncology
Amsterdam, Netherlands, 1100 DD
Actively Recruiting
2
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
Actively Recruiting
3
Catharina ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
4
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Not Yet Recruiting
5
LUMC
Leiden, Netherlands
Not Yet Recruiting
6
Radboud UMC
Nijmegen, Netherlands
Actively Recruiting
7
Erasmus MC
Rotterdam, Netherlands
Not Yet Recruiting
8
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
J
Joris Bos, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here