Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer (NCT06250036) | Clinical Trial Compass
RecruitingPhase 2
Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer
United Kingdom50 participantsStarted 2025-02-20
Plain-language summary
A phase II study of peri-operative anti-PD1 (Zimberelimab) +/- anti-TIGIT (Domvanalimab) in resectable mismatch repair deficient (MMRd)/ high micro-satellite instability (MSI-H) gastric/gastro-oesophageal junctional (GOJ) adenocarcinoma (AC)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
* Age: ā„18 years
* Histologically confirmed gastric or gastro-oesophageal junctional (GOJ) adenocarcinoma (inclusive of Siewert-stein classification type I-III (62))
* MMRd/MSI-H. There are three different methods validated for detection (63) :
* Immunohistochemistry (IHC) staining for expression of MMR proteins (MLH1, MSH2, PMS2 and MSH6), MMRd defined as loss of function or one or more of these proteins.
* Polymerase chain reaction (PCR) amplification of microsatellite sequences
* Next-generation sequencing (NGS) for detection of MSI
* Stage II-IIIB: TNM T2-T4, N0-N3, M0
* Absence of distant metastatic disease on CT scan + PET CT + staging laparoscopy prior to study entry.
* MDT determined suitable for surgery and MDT believes an R0 resection is achievable after neo-adjuvant therapy (resectable disease)
* No prior anti-cancer therapy for gastric / GOJ adenocarcinoma
* ECOG performance status 0-2
Laboratory parameters
⢠Adequate haematologic and end-organ function defined by the following laboratory test results: Haematology: Absolute neutrophil count \> 1.5 x 109/L Platelets \> 100 x 109/L Haemoglobin \> 90 x 109/L (can be post-transfusion) Biochemistry: Serum Creatinine Clearance \>50ml/min (calculated using Cockcroft-Gault formula Appendix X)
Liver function: Bilirubin within normal limits ALT/AST ā¤2.5x ULN
Coagulation profile (for patients not receiving therapeutic anticoagulation):
International Normalised Ratio (INR) \< 1.5 Activated Prā¦
What they're measuring
1
Efficacy of zimberelimab +/- domvanalimab in patients with resectable MMRd/MSI-H gastric/GOJ adenocarcinoma who proceed to surgery