T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Sol… (NCT05200559) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors
United States25 participantsStarted 2022-09-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to comply with the study protocol, in the investigator's judgment
* Histologically or cytologically confirmed solid tumors (cutaneous melanoma, non-small cell lung cancer, renal cell carcinoma, endometrial cancer, ovarian cancer, MSI-H solid tumors (deficient mismatch repair system or other solid tumors) that have progressed on or refractory to standard of care therapies for their disease
* Phase I dose escalation phase
* Advanced metastatic or recurrent solid tumors (where pembrolizumab is approved and/or have shown efficacy) that have progressed on or refractory to standard of care therapies for their disease
* Prior anti-PD1 or PDL1 therapy is allowed
* Prior anti-CTLA4 therapy is allowed if had anti-CTLA4 free interval of 6 months or more
* At least one prior line of therapy in the dose escalation phase
* Phase Ib dose expansion cohorts
* Platinum-resistant recurrent ovarian cancer (recurred within 6 months or less of prior platinum therapy) or post-PD1/PDL1 MSI-H cancers (mismatch repair deficient tumors). Patients in the ovarian cancer cohort must have received chemotherapy plus bevacizumab unless bevacizumab is contra-indicated or considered risky per treating physician.
* Prior 1-5 lines of therapy for dose expansion
* Prior anti-PD1/PDL1 therapy is allowed in the MSI-H cohort but not in the ovarian cohort
* Prior anti-CTLA4 therapy is not allowed.
* Primary platinum- refractory cancers are excluded in the dose expans…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines E7777 with pembrolizumab specifically to deplete T-regulatory cells — can you explain what that means for my immune system, and what unique risks that approach might carry compared to immunotherapy alone?
2Since this is a Phase 1/2 trial and one of the main goals is still figuring out the right dose of E7777, how does that uncertainty about dosing affect what's currently known about safety for someone with epithelial ovarian cancer like me?
3The trial is active but no longer enrolling new patients — does that mean there's any chance of getting access to this combination through a different pathway, like compassionate use or a follow-on study?
4The trial is measuring changes in immune cells both in the tumor and in the blood — would I need repeated biopsies or frequent blood draws, and how might that schedule fit with my current treatment and daily life?
5Given that this trial focuses on recurrent or metastatic disease, would you recommend I consider standard second-line options first, or is there a reason this experimental combination might be worth discussing as a next step for my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.