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Pembrolizumab for Ovarian Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ovarian CancerPembrolizumab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
TCR-transduced T cells
1
CAR.B7-H3
1
NG-350A plus Pembrolizumab

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Month 12
Recommended Phase 2 Dose (RP2D)
Up to 5 years
Change in CD8+ T cells - peripheral blood
Change in CD8+ T cells in tumor
Change in T-regulatory cells - peripheral blood
Body Weight Changes
Body Weight Changes
Change in myeloid cells in tumor
Objective Response
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
TCR-transduced T cells
1
CAR.B7-H3
1
NG-350A plus Pembrolizumab

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

E7777 + Pembrolizumab
1 of 1

Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

E7777 + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, E7777 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2240
E7777
2016
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Cancers that have spread to other parts of the body and that haven't responded to previous treatments are candidates for pembrolizumab.
Solid tumors that have been confirmed through a histology or cytology test and that fall into one of the following categories: melanoma, non-small cell lung cancer, renal cell carcinoma, endometrial cancer, ovarian cancer, and solid tumors with a deficient mismatch repair system (MSI-H) that have not responded to standard therapies for their condition.
Ovarian cancer patients who have had a recurrence within 6 months of receiving platinum-based chemotherapy, or who have post-PD1/PD-L1 cancers that are mismatch repair deficient, are eligible for this study
The ability to comply with the study protocol, as determined by the investigator.
of Chemo-I Chemo-I is a new chemotherapy drug that is currently being tested in a phase I dose escalation phase
You are allowed to have received treatment with anti-PD1 or PDL1 drugs in the past.
and had no prior exposure to ipilimumab People who have not had any exposure to the ipilimumab drug before are allowed to have anti-CTLA4 therapy as long as they have had a break of 6 months or more from the previous therapy.
is required At least one prior line of therapy is needed during the dose escalation phase.
of the study are currently enrolling A phase Ib dose expansion study is currently enrolling patients.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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