(VVD-133214-02 / 23236) A Phase 2, Randomized, Open-label Study of VVD-133214 in Combination with Pembrolizumab compared to Pembrolizumab Monotherapy in Participants with Advanced Colorectal Adenocarcinoma (CRC) Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (DMMR)

Condition studied

Advanced colorectal adenocarcinoma

Investigational medicinal product(s)

Every trial of VVD-133214 and Pembrolizumab across our registers →

Eligibility

Primary endpoint

Landmark progression-free survival rate at 6 months, as assessed by the Investigator, defined as the proportion of participants who are alive and free from disease progression per RECIST v1.1

Endpoint detail

Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0), Incidence, severity and frequency of adverse events, anti-tumor activity, pharmacokynetics / pharmacodynamics (PK/PD), and assessment of disease biomarkers for two doses of VVD-133214 combined with the SoC dose of pembrolizumab, PK profiles and parameters derived for VVD- 133214 including but not limited to: Cmax, Tmax, and AUC for various time intervals following single and multiple doses of VVD-133214, Objective response rate (ORR), Disease control rate (DCR), Duration of response (DOR), medial progression-free survival (mPFS) according to RECIST v1.1 as assessed by the Investigator