OncoMatch/Clinical Trials/NCT05200559
T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors
Is NCT05200559 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Pembrolizumab and E7777 for epithelial ovarian cancer.
Treatment: Pembrolizumab · E7777 — Epithelial ovarian cancer (OC) is the most lethal gynecologic cancer: nearly 22,000 women are diagnosed with OC in the US annually and 63% are expected to die from their disease. The 5-year overall survival rate is unacceptably low at 20-30%, with \> 50% of patients experiencing recurrence of their disease. Recurrent, platinum-resistant OC is characterized by a low response to chemotherapy (\<10-15%) and poor prognosis, with overall survival estimated to be \<12 months. Thus, there is an urgent need to identify novel therapies to improve outcomes for patients with recurrent, platinum resistant OC. The primary focus in this trial is targeting tumor associated immunosuppressive T-regs with E7777 combined with PD-1 inhibitor, pembrolizumab. This trial will enroll patients with solid tumors in the dose escalation portion and specified cohorts in the dose expansion portion. In the Phase I portion, 18-30 patients will be enrolled. In the dose expansion portion, approximately 40 patients (20 in each cohort) will be enrolled. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Allowed: MSH2 deficient mismatch repair system
MSI-H solid tumors (deficient mismatch repair system)
Allowed: MSH6 deficient mismatch repair system
MSI-H solid tumors (deficient mismatch repair system)
Allowed: MLH1 deficient mismatch repair system
MSI-H solid tumors (deficient mismatch repair system)
Allowed: PMS2 deficient mismatch repair system
MSI-H solid tumors (deficient mismatch repair system)
Disease stage
Required: Stage IV
Metastatic disease required
Advanced metastatic or recurrent solid tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — disease-specific standard of care
progressed on or refractory to standard of care therapies for their disease
Must have received: bevacizumab (bevacizumab) — ovarian cancer cohort
Patients in the ovarian cancer cohort must have received chemotherapy plus bevacizumab unless bevacizumab is contra-indicated or considered risky per treating physician.
Cannot have received: anti-CTLA-4 therapy
Exception: allowed in dose escalation phase if anti-CTLA4 free interval of 6 months or more; not allowed in dose expansion
Prior anti-CTLA4 therapy is allowed if had anti-CTLA4 free interval of 6 months or more (dose escalation); not allowed in dose expansion
Cannot have received: anti-PD-1/PD-L1 therapy
Exception: allowed in dose escalation and in MSI-H expansion cohort; not allowed in ovarian cancer expansion cohort
Prior anti-PD1 or PDL1 therapy is allowed (dose escalation); allowed in MSI-H expansion cohort but not in ovarian cohort
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1500/L) without G-CSF support; Platelet count ≥ 100 × 10^9/L (100,000/L) without transfusion; Hemoglobin ≥ 90 g/L (9 g/dL), may be transfused to meet criterion
Kidney function
Serum creatinine ≤1.5 × ULN
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤2.5 × ULN; with liver metastases: AST and ALT ≤ 5 × ULN; with liver or bone metastases: ALP ≤ 5 × ULN; serum bilirubin ≤1.5 × ULN (≤3 × ULN if Gilbert disease)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
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