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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSecondary outcome measures
Objective Response
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is a sample of your tumor available for research purposes.I have had cancer spread to the lining of my brain and spinal cord.I am allergic to certain medication ingredients, including those from Chinese hamster ovary cells.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I don't have any health issues that prevent me from taking new medications.My ovarian cancer is resistant to platinum-based treatments, or I have MSI-H cancer after PD1/PDL1 therapy.You have a history of HIV infection or tested positive for HIV.I have not had a severe infection in the last 4 weeks.I haven't taken any immune-weakening drugs in the last 2 weeks.I have not received a live vaccine in the last 4 weeks.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I had anti-CTLA4 therapy but it's been 6 months or more since my last treatment.You have a disease that can be measured according to specific guidelines.I am HIV positive, on stable treatment, have a CD4 count ≥ 200/μL, and an undetectable viral load.I have active tuberculosis.I frequently need procedures to remove excess fluid from my chest or abdomen.I have not had another type of cancer besides my current one in the last 3 years.My cancer is confirmed and has not responded to standard treatments.I have a history of Hepatitis B or active Hepatitis C.I have previously received treatments targeting the immune system.I have not taken any strong antibiotics in the last 2 weeks.My blood and organs are functioning well.I have pain from my cancer that isn't relieved by medication.I agree to not have unprotected sex or donate sperm.You are expected to live for at least 6 more months.I have not had major surgery in the last 4 weeks.I haven't had major heart problems in the last 3 months.I have high calcium levels in my blood that are causing symptoms.You have an ongoing or past autoimmune disease or immune deficiency.I am fully active or can carry out light work.My cancer has not responded to or has worsened after standard treatments.You have had serious allergic reactions to certain types of medications in the past.I have had a previous transplant of stem cells or an organ.I have previously received anti-PD1 or PDL1 therapy.If you are not taking blood thinners, your blood clotting tests should not be more than 1.5 times the normal range.Your blood albumin level is at least 25 grams per liter (2.5 grams per deciliter).
Research Study Groups:
This trial has the following groups:- Group 1: E7777 + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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