Trials / Recruiting
RecruitingNCT06250036
Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer
A Randomised Phase II Study of Zimberelimab Anti-PD1 immunOtherapy +/- Domvanalimab Anti-TIGIT Immunotherapy in Resectable Mismatch Repair Deficient Gastric and Gastro-oesophageal Junctional AdenoCarcinoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Royal Marsden NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Detailed description
Primary objective The primary objective of the trial is to evaluate the efficacy of zimberelimab +/- domvanalimab as peri-operative treatment in resectable MMRd/MSI-H gastric/GOJ adenoca. A chemotherapy-sparing approach. The primary endpoint is pathological complete response rate at surgery, and to identify which is the most promising experimental arm (zimberelimab alone vs zimberelimab in combination with domvanalimab). Secondary objectives * To assess the safety and tolerability of zimberelimab+/- domvanalimab in this disease setting * To further assess the efficacy of zimberelimab+/- domvanalimab in terms of radiological response rate, R0 resection rate, progression free survival (PFS) and overall survival (OS) * To evaluate surgical outcomes following treatment with zimberelimab +/- domvanalimab Translational analyses on tissue and blood biomarkers aimed at identifying those who derive the most benefit from this immunotherapy combination, and those who are non/poor responders.
Conditions
- Locally Advanced Gastric Adenocarcinoma
- MSI-H/dMMR Gastric Cancer
- MSI-H/dMMR Gastroesophageal-junction Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Single agent zimberelimab | Single agent zimberelimab (PD-1 inhibitor) Q3W |
| DRUG | Combination zimberelimab + domvanalimab | Combination zimberelimab + domvanalimab (TIGIT inhibitor) Q3W |
Timeline
- Start date
- 2025-02-20
- Primary completion
- 2027-03-20
- Completion
- 2031-09-01
- First posted
- 2024-02-08
- Last updated
- 2025-08-21
Locations
9 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06250036. Inclusion in this directory is not an endorsement.