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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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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.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Change in number of CD3+ cells
Change in number of CD8+ cells
Progression-Free Survival (PFS)
Other outcome measures
CD4 Tbet
Grandzyme B
NK Cells
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
~1940
Pembrolizumab
2017
Completed Phase 2
~2010
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
3,888 Previous Clinical Trials
5,059,890 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
Robert EdwardsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to pembrolizumab or cisplatin.I am 18 years old or older.I have not had radiation therapy in the last 2 weeks or any previous pelvic radiation.I've completed platinum-based therapy over 6 months ago and my cancer didn't worsen during that time.My brain metastases are stable and not causing symptoms.My tumor is not highly aggressive, and I don't have cancer spread in my abdomen, except for ovarian pseudomyxomas.I have an autoimmune disease treated in the last 2 years or had serious lung inflammation.My cancer has returned in the abdomen for the 1st or 2nd time and originated from the ovary, fallopian tube, or peritoneum.My organs are functioning well, as confirmed by recent tests.I haven't taken any cancer treatment or investigational drugs in the last 4 weeks.I do not have an active infection or a history of HIV, Hepatitis B/C, or TB that could affect the study.I am a good candidate for laparoscopy and have no history of serious abdominal issues.I haven't had cancer in the last 3 years, except for certain types allowed.My cancer in the abdomen can be measured by scans.I am fully active or restricted in physically strenuous activity but can do light work.I have not taken steroids or immunosuppressants in the last 7 days.I have not received a live vaccine in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: cisplatin + rintatolimod + 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.
Is this experiment currently accepting participants?
"As stated by clinicaltrials.gov, this medical trial is enrolling patients and has been active since the 28th of January 2019 with its last edit on March 3rd 2022."
Answered by AI
Are there any additional experiments involving the use of Pembrolizumab?
"Presently, 355 Phase 3 trials involving Pembrolizumab are being conducted with 1557 studies overall. Although Buffalo, New york has a large concentration of these clinical tests, there are 69992 other sites around the world running similar experiments."
Answered by AI
What is the upper bound for participant enrollment in this experiment?
"Affirmative. The clinicaltrials.gov website corroborates that this medical trial is in its recruitment phase, with the initial post date being 1/28/2019 and latest edit taking place on 3/3/2022. 45 subjects are required from a single site for successful completion of the project."
Answered by AI
What clinical indications is Pembrolizumab typically employed to alleviate?
"Pembrolizumab is a viable treatment option for malignant neoplasms, cases of unresectable melanoma, and those with high microsatellite instability."
Answered by AI
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