Actively Recruiting
T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors
Led by Alexander B Olawaiye, MD · Updated on 2024-12-05
70
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
A
Alexander B Olawaiye, MD
Lead Sponsor
D
Dr. Reddys Laboratories, SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to follow study protocol as judged by investigator
- Confirmed solid tumors including melanoma, non-small cell lung cancer, renal cell carcinoma, endometrial cancer, ovarian cancer, MSI-H tumors refractory or progressed after standard therapies
- For dose escalation: advanced metastatic or recurrent solid tumors where pembrolizumab is approved or appropriate
- Prior anti-PD1 or PD-L1 therapy allowed in dose escalation
- Prior anti-CTLA4 therapy allowed if at least 6 months since last dose
- At least one prior line of therapy for dose escalation
- For dose expansion cohorts: platinum-resistant recurrent ovarian cancer or post-PD1/PDL1 MSI-H cancers
- 1 to 5 prior lines of therapy for dose expansion
- Prior anti-PD1/PDL1 therapy allowed in MSI-H cohort but not ovarian cohort
- No prior anti-CTLA4 therapy in dose expansion
- Measurable disease per RECIST v1.1
- Availability of tumor specimen for biomarker research
- ECOG performance status 0-1
- Life expectancy at least 6 months
- Adequate blood counts and organ function within 14 days prior to treatment
- Stable HIV infection on therapy with CD4 count ≥ 200 and undetectable viral load
- No known Hepatitis infection
- Women of childbearing potential must agree to use reliable contraception or remain abstinent during treatment and 5 months after
- Men must agree to use condoms or remain abstinent during treatment and 5 months after
You will not qualify if you...
- History of leptomeningeal disease; brain metastases allowed if treated and stable for 6 months without steroids
- Uncontrolled tumor-related pain or symptomatic lesions needing treatment
- Uncontrolled fluid buildup requiring frequent drainage
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune disease or immune deficiency except well-controlled hypothyroidism, type 1 diabetes on insulin, or mild dermatologic conditions with strict criteria
- History or evidence of active pneumonitis or certain lung diseases
- Active tuberculosis
- Significant cardiovascular disease within 3 months
- Major surgery within 4 weeks or planned during study
- Second primary malignancy within 3 years except low-risk cancers
- Severe infection or hospitalization for infection within 4 weeks
- Therapeutic antibiotics within 2 weeks prior to treatment
- Prior allogeneic stem cell or organ transplant
- Any condition or lab abnormality increasing risk or affecting study results
- Live vaccine within 4 weeks prior or planned during treatment or 5 months after
- Known HIV infection except stable on therapy with viral load confirmation
- Known active Hepatitis B or C unless on stable antiviral therapy with low viral load
- Investigational therapy within 28 days prior
- Prior CD137 agonists or immune checkpoint therapies except allowed in criteria
- Immunostimulatory agents within 4 weeks or 5 half-lives prior
- Systemic immunosuppressive meds within 2 weeks prior except low-dose or specific exceptions
- Severe allergic reactions to similar antibodies or fusion proteins
- Known allergies to components of pembrolizumab or E7777
- Pregnancy, breastfeeding, or intent to become pregnant during treatment or 6 months after; negative pregnancy test required for women of childbearing potential
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
K
Kelsey Mitch, RN
CONTACT
L
Lucia Borasso, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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