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PARP Inhibitor
Olaparib + Pembrolizumab for Advanced Cancer
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has either centrally-confirmed known or suspected deleterious mutations in ≥1 of the specified 15 genes involved in HRR or centrally-confirmed HRD based on the Lynparza HRR-HRD assay.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of study treatment initiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~3 years
Awards & highlights
Study Summary
This trial will test whether adding olaparib to pembrolizumab will help treat patients with solid tumors that have mutations that affect the Homologous Recombination Repair process.
Who is the study for?
Adults with advanced solid tumors that have specific genetic mutations or deficiencies, who've had some response to platinum-based therapies and are not eligible for curative treatment. They must be in relatively good health, agree to contraception, and not be pregnant or breastfeeding. Exclusions include certain blood disorders, active infections or autoimmune diseases, recent treatments with other cancer drugs or vaccines, and known allergies to trial medications.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Olaparib (MK-7339), which targets cancer cells with DNA repair issues; and Pembrolizumab (MK-3475), an immunotherapy drug. The study aims to see how well these drugs work together in treating patients whose tumors have specific genetic features making them hard to treat.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, allergic reactions during infusion of the medication, lung inflammation that could cause breathing difficulties among others. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has harmful mutations in specific genes related to DNA repair.
Select...
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 ~3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~3 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) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups
Secondary outcome measures
Duration of Response (DOR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations
Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
+9 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Olaparib+PembrolizumabExperimental Treatment2 Interventions
Participants receive olaparib 300 mg via oral tablet 2 times each day PLUS pembrolizumab 200 mg via intravenous infusion on Day 1 of each 21-day cycle. Participants may receive olaparib+pembrolizumab for up to approximately 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,528 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,253 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high-dose steroids or other drugs that weaken my immune system.I have not received a live vaccine in the last 30 days.I have received an organ or tissue transplant from another person.I have not had major surgery in the last 2 weeks or am fully recovered from any major surgery.My cancer has spread to my brain or spinal cord.My last cancer treatment, which included platinum-based therapy, was effective.My cancer has harmful mutations in specific genes related to DNA repair.I have been treated with immunotherapy targeting specific cancer growth pathways.I have an autoimmune disease treated with medication in the last 2 years.I am currently being treated for an infection.I have not taken any colony-stimulating factors in the last 28 days.My cancer responded to platinum-based treatment without becoming resistant.I have been diagnosed with HIV.I have had a bone marrow or cord blood transplant.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.I have or had lung inflammation not caused by infection, treated with steroids.I have not had a blood transfusion in the last 4 months.I have active hepatitis B or C.I cannot take pills by mouth or have a condition that affects how my body absorbs medication.I have not taken any cancer treatment or experimental drugs in the last 4 weeks.I do not have any uncontrolled heart conditions.I am not taking strong or moderate drugs that affect drug metabolism and can't stop them for the study.I have recovered from side effects of past treatments, except for hair loss.I am not taking strong or moderate inhibitors of CYP3A4 that can't be stopped for the study.I have been treated with olaparib or another PARP inhibitor before.I had radiotherapy less than 2 weeks ago.My advanced cancer cannot be surgically removed, and standard treatments have failed.My organs are functioning well.I have been diagnosed with MDS, AML, or conditions that suggest I might have them.I agree to use birth control and not donate sperm for 3 months after my last olaparib dose.I have active tuberculosis.My cancer can be measured by scans according to specific criteria.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant or breastfeeding, can use birth control, and will not breastfeed during and after the study.You are allergic to the study treatments or any of the substances used in them.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib+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 research project presently recruiting participants?
"Affirmative. Information hosted on clinicaltrials.gov indicates that this experiment is presently accepting participants, having first been listed in November 2019 and last updated two years later."
Answered by AI
Are there any precedent investigations into the effects of Olaparib?
"Olaparib was initially explored in 2005 at Research Site. Since then, 314 clinical trials have concluded and 1114 are currently underway; San Francisco is the epicentre for many of these investigations."
Answered by AI
What is the size of the cohort that is being monitored for this experiment?
"Affirmative. The information published on clinicaltrials.gov suggests that this scientific experiment is currently recruiting for 300 participants across 18 sites, with the first post appearing November 18th 2019 and latest update completed November 29th 2022."
Answered by AI
Is this pioneering clinical trial a first-time endeavor?
"Since 2005, when the initial research was sponsored by AstraZeneca and included 98 patients, Olaparib has gone on to receive Phase 1 drug approval. Nowadays, there are 1114 clinical studies being conducted across 66 nations in 3058 cities."
Answered by AI
Are there numerous health care centers trialing this protocol domestically?
"Currently, 18 clinical trial sites are recruiting patients for this medical study. These locations span from San Francisco to Birmingham and Fairfax as well as several other cities. To limit the need for travel, we suggest selecting a site close by when enrolling in the trial."
Answered by AI
How detrimental is Olaparib for patients?
"Olaparib has been assessed as a 2 on the safety scale, given that Phase 2 only offers limited evidence of its security but no proof of efficacy."
Answered by AI
In what capacity is Olaparib generally employed?
"Olaparib is commonly utilized to treat inoperable melanoma, as well as high risk of recurrence cases and microsatellite instability conditions."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)
What portion of applicants met pre-screening criteria?
Met criteria
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