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Pembrolizumab + Chemotherapy + MK-4830 for Ovarian Cancer
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer.
Is a candidate for interval debulking surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 40 weeks
Awards & highlights
Study Summary
This trial is testing whether a new combination therapy can more effectively reduce circulating tumor DNA than a standard treatment in women with high-grade serous ovarian cancer.
Who is the study for?
This trial is for individuals with advanced ovarian cancer who can undergo chemotherapy and surgery, have adequate organ function, and can provide a tumor biopsy. It's not for those who've had certain recent treatments or vaccines, active infections including HIV or hepatitis B/C, other cancers within 3 years, prior ovarian cancer treatment, uncontrolled blood pressure, severe allergies to study drugs or their ingredients.Check my eligibility
What is being tested?
The trial tests if adding MK-4830 to pembrolizumab (an immunotherapy drug) plus standard chemo works better than just pembrolizumab with chemo in reducing tumor DNA in the blood after three cycles of treatment in patients with high-grade serous ovarian cancer.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, immune system-related inflammation affecting various organs (like lungs), fatigue from chemotherapy agents like paclitaxel and carboplatin as well as potential bleeding risks associated with Avastin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced ovarian, peritoneal, or fallopian tube cancer.
Select...
I am eligible for surgery to remove as much cancer as possible.
Select...
I can provide a sample of my tumor for testing.
Select...
I am eligible for carboplatin and paclitaxel chemotherapy before and after surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 40 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
Secondary outcome measures
Change from Baseline in Neoadjuvant ctDNA
Chemotherapy Response Score (CRS)
Number of Participants Who Discontinued Study Treatment Due to an AE
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Standard of Care (SOC) + MK-4830Experimental Treatment6 Interventions
Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2, carboplatin Area Under the Curve (AUC) 5 to 6, (or docetaxel 75 mg/m^2), and MK-4830 800 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2, carboplatin AUC 5 to 6, (or docetaxel 75 mg/m^2), MK-4830 800 mg, and avastin (or biosimilar) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Group II: Pembrolizumab + SOCActive Control5 Interventions
Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2, carboplatin AUC 5 to 6 and (or docetaxel 75 mg/m^2) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m^2, carboplatin AUC 5 to 6, (or docetaxel 75 mg/m^2) and avastin (or biosimilar) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Docetaxel
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,411 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,320 Total Patients Enrolled
14 Trials studying Ovarian Cancer
3,692 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to my brain or spinal cord.I am receiving or will receive chemotherapy directly into my abdomen as my first treatment.I have not received a live vaccine in the last 30 days.I had surgery less than 6 months ago for early-stage ovarian or fallopian tube cancer.I have not had major surgery in the last 3 weeks or am fully recovered from any major surgery.You have a severe allergy to pembrolizumab, carboplatin, paclitaxel, or Avastin.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am eligible for surgery to remove as much cancer as possible.I have had bleeding issues within the last 6 months.My cancer is advanced ovarian, peritoneal, or fallopian tube cancer.I am currently being treated for an infection.I have or had lung inflammation that needed steroids.I have been diagnosed with HIV.I have not taken colony-stimulating factors in the last 4 weeks.I am currently experiencing a significant blockage in my intestines.My high blood pressure is not under control.I can provide a sample of my tumor for testing.I have a history of hepatitis B or active hepatitis C.I am eligible for carboplatin and paclitaxel chemotherapy before and after surgery.I have received an organ or tissue transplant from another person.My ovarian cancer is not high-grade serous.My organs are functioning well.I have another cancer that is getting worse or was treated in the last 3 years.I have received treatment for ovarian cancer before.I have been treated for an autoimmune disease in the last 2 years.I have been treated with specific immune system targeting drugs before.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + SOC
- Group 2: Pembrolizumab + Standard of Care (SOC) + MK-4830
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 patients currently being enrolled in this clinical trial?
"The most recent information available on clinicaltrials.gov suggests that this trial is still enrolling patients. The initial posting date was July 25th, 2020 and the last edit was made November 15th of the same year. This study requires 160 participants total, to be recruited from 8 different medical facilities."
Answered by AI
What are the possible side effects of MK-4830?
"Based on our observations, we believe that MK-4830 ranks a 2 in terms of safety. There is data affirming its safety but none backing up its efficacy claims."
Answered by AI
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