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Platinum-based Chemotherapy

Chemo-Immunotherapy for Recurrent Ovarian Cancer

Phase 1 & 2
Recruiting
Led By Robert Edwards, MD
Research Sponsored by Robert Edwards
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be at least 18 years of age on the day of signing informed consent.
Patients must have first or second peritoneal recurrence of epithelial adenocarcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin with histologic documentation of the original primary tumor.
Must not have
Patients with severe hypersensitivity to pembrolizumab and/or any of its excipients, or known allergy to cisplatin chemotherapy.
Patients who have received prior radiotherapy within 2 weeks of start of study treatment or previous pelvic radiation therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new combination of drugs to treat ovarian cancer. The drugs will be given through IV and intraperitoneal (IP) infusion. The trial will evaluate the effectiveness and safety of the new combination.

Who is the study for?
This trial is for adults over 18 with recurrent platinum-sensitive ovarian cancer, who can undergo laparoscopy and have no major abdominal issues or severe allergies to the drugs used. They must not be pregnant, breastfeeding, or planning pregnancy soon. Participants should be in good physical condition (ECOG 0-1) and agree to follow-up monitoring.
What is being tested?
The study tests a combination of intraperitoneal cisplatin and rintatolimod with IV pembrolizumab on patients with first or second recurrence of ovarian cancer. It aims to assess safety and effectiveness in those who responded well previously to platinum-based therapy.
What are the potential side effects?
Possible side effects include allergic reactions to medications, kidney problems from cisplatin, immune-related issues due to pembrolizumab like inflammation in organs, fatigue, digestive disturbances, blood disorders, increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My cancer has returned in the abdomen for the 1st or 2nd time and originated from the ovary, fallopian tube, or peritoneum.
Select...
My cancer in the abdomen can be measured by scans.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic to pembrolizumab or cisplatin.
Select...
I have not had radiation therapy in the last 2 weeks or any previous pelvic radiation.
Select...
My tumor is not highly aggressive, and I don't have cancer spread in my abdomen, except for ovarian pseudomyxomas.
Select...
I have an autoimmune disease treated in the last 2 years or had serious lung inflammation.
Select...
I do not have an active infection or a history of HIV, Hepatitis B/C, or TB that could affect the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Change in number of CD3+ cells
Change in number of CD8+ cells
Progression-Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: cisplatin + rintatolimod + pembrolizumabExperimental Treatment3 Interventions
Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Pembrolizumab
2017
Completed Phase 3
~3130
Rintatolimod
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

AIM ImmunoTech Inc.Industry Sponsor
14 Previous Clinical Trials
663 Total Patients Enrolled
1 Trials studying Ovarian Cancer
25 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,755 Total Patients Enrolled
43 Trials studying Ovarian Cancer
6,584 Patients Enrolled for Ovarian Cancer
Robert EdwardsLead Sponsor
Robert Edwards, MDPrincipal Investigator - UPMC Hillman Cancer Center
Magee-Women's Hospital of UPMC, Robert G Edwards MD PC, UPMC Presbyterian
University Of Pittsburgh School Of Medicine (Medical School)
Mercy Hosp-Pittsburgh (Residency)
2 Previous Clinical Trials
221 Total Patients Enrolled
1 Trials studying Ovarian Cancer
50 Patients Enrolled for Ovarian Cancer

Media Library

Cisplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03734692 — Phase 1 & 2
Ovarian Cancer Research Study Groups: cisplatin + rintatolimod + pembrolizumab
Ovarian Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03734692 — Phase 1 & 2
Cisplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03734692 — Phase 1 & 2
~11 spots leftby Dec 2026
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