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Anti-tumor antibiotic
Pembrolizumab for Ovarian Cancer
Phase 2
Waitlist Available
Led By Ursula Matulonis, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This study is evaluating whether a combination of chemotherapy and immunotherapy might be a better treatment for ovarian cancer.
Eligible Conditions
- Ovarian Cancer
- Peritoneal Neoplasm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate [CBR]
Secondary outcome measures
Duration of Response [DOR]
Overall Response Rate [ORR]
Overall Survival
+2 moreSide 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%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab in Combination With PLDExperimental Treatment2 Interventions
A safety lead in with 6 patients will be studied prior the start of the treatment.
If 2 out of the first 6 patients develop a dose limiting toxicity (DLT), the dose of PLD will be reduced.
If no more than 1 patient of the first 6 patients has evidence of dose limiting toxicities, the dose level will be considered the maximum tolerated dose (MTD)
Pegylated Liposomal Doxorubicin (PLD) pre-determine dosage will be administered every 4 weeks via IV
Pembrolizumab will be administered as a 30 min IV infusion every 3 weeks at a pre-determine dosage
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Doxorubicin
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,846 Total Patients Enrolled
39 Trials studying Ovarian Cancer
4,504 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,878 Previous Clinical Trials
5,053,171 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,574 Patients Enrolled for Ovarian Cancer
Ursula Matulonis, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
322 Total Patients Enrolled
3 Trials studying Ovarian Cancer
76 Patients Enrolled for Ovarian Cancer
Frequently Asked Questions
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