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Immunomodulator

E7777 + Pembrolizumab for Ovarian Cancer

Phase 1 & 2
Recruiting
Led By Haider Mahdi, MD
Research Sponsored by Haider Mahdi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Platinum-resistant recurrent ovarian cancer or post-PD1/PDL1 MSI-H cancers
Patients with a positive HIV disease are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/μL, and have an undetectable viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new combination therapy for epithelial ovarian cancer, which is the most lethal gynecologic cancer. The new therapy targets tumor associated immunosuppressive T-regs, which may improve outcomes for patients with recurrent, platinum resistant OC.

Who is the study for?
This trial is for adults with recurrent ovarian cancer resistant to platinum-based chemotherapy or post-PD1/PDL1 MSI-H cancers. Participants must have a life expectancy of at least 6 months, manageable health status (ECOG 0-1), and adequate organ function. Those with HIV can join if stable on therapy. Women who can bear children and men must agree to use contraception.Check my eligibility
What is being tested?
The study tests E7777, aimed at depleting immunosuppressive T-cells, combined with pembrolizumab, an immune checkpoint inhibitor. It includes a dose escalation phase for various solid tumors and a dose expansion specifically for certain cancer types.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in different body parts, infusion-related reactions from the drug administration process, fatigue, possible blood disorders, increased risk of infections due to immune modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ovarian cancer is resistant to platinum-based treatments, or I have MSI-H cancer after PD1/PDL1 therapy.
Select...
I am HIV positive, on stable treatment, have a CD4 count ≥ 200/μL, and an undetectable viral load.
Select...
I had anti-CTLA4 therapy but it's been 6 months or more since my last treatment.
Select...
My cancer is confirmed and has not responded to standard treatments.
Select...
My blood and organs are functioning well.
Select...
I agree to not have unprotected sex or donate sperm.
Select...
I am fully active or can carry out light work.
Select...
My cancer has not responded to or has worsened after standard treatments.
Select...
I have previously received anti-PD1 or PDL1 therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CD8+ T cells - peripheral blood
Change in CD8+ T cells in tumor
Change in T-regulatory cells - peripheral blood
+4 more
Secondary outcome measures
Objective Response
Overall survival (OS)
Progression-free survival (PFS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: E7777 + PembrolizumabExperimental Treatment2 Interventions
Phase l: E7777: Dose Level 1, 3 µg/kg; Dose Level 2, 6 µg/kg; Dose Level 3, 9 µg/kg; Dose Level 4, 12 µg/kg Day 1-3 - given up to 8 cycles (dose-limiting toxicities assessed for first two cycles, only) Pembrolizumab: 200 mg, IV on Day 1 (21-day cycle) Phase ll: E7777: administered on Day 1-3 at Phase 2 Recommended Dose (P2RD); Day 1-3 up to 8 cycles Pembrolizumab: 200 mg, IV on Day 1 (21-day cycle)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
E7777
2016
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Haider MahdiLead Sponsor
5 Previous Clinical Trials
123 Total Patients Enrolled
4 Trials studying Ovarian Cancer
123 Patients Enrolled for Ovarian Cancer
Dr. Reddys Laboratories, SAIndustry Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Haider Mahdi, MDPrincipal InvestigatorUPMC Hillman Cancer Center
4 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Ovarian Cancer
64 Patients Enrolled for Ovarian Cancer

Media Library

E7777 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05200559 — Phase 1 & 2
Ovarian Cancer Research Study Groups: E7777 + Pembrolizumab
Ovarian Cancer Clinical Trial 2023: E7777 Highlights & Side Effects. Trial Name: NCT05200559 — Phase 1 & 2
E7777 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05200559 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this clinical trial?

"That is correct. The clinical trial was first posted on 9/30/2022 and was most recently edited on 10/4/2022. The study is searching for 70 participants between 1 locations."

Answered by AI

How many people have signed up to participate in this trial?

"That is correct, according to the information provided by clinicaltrials.gov. This study was posted on September 30th, 2020 and updated October 4th, 2020. They are seeking 70 individuals total at a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~37 spots leftby Dec 2025