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PARP Inhibitor
Pembrolizumab + Olaparib for Bile Duct Cancer
Phase 2
Waitlist Available
Led By Aiwu R He
Research Sponsored by Georgetown University
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 1 year
Awards & highlights
Summary
This trial tests a combination of two drugs, olaparib and pembrolizumab, in patients with advanced bile duct cancer who haven't responded to standard treatment. Olaparib makes it harder for cancer cells to repair themselves, while pembrolizumab helps the immune system attack the cancer. The goal is to see if this combination can improve treatment response rates and extend patient survival.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
efficacy in terms of response rate
Secondary study objectives
Safety and tolerability
efficacy in terms of duration of response
efficacy in terms of overall survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment2 Interventions
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle)
Olaparib bid, Oral tablet continuously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Olaparib
FDA approved
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
137,197 Total Patients Enrolled
Aiwu R HePrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
14 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have mild neuropathy that is classified as Grade 2 or below, you may still be eligible for the study.You have a mental health condition or struggle with addiction that might make it difficult to participate in the trial.You are currently receiving or have received an experimental treatment or device in a research study within the last four weeks.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin or cervical cancer that have been treated successfully.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
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.
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