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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.

Must not have

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

Has had an allogenic tissue/solid tumor organ transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My cancer has harmful mutations in specific genes related to DNA repair.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I have received an organ or tissue transplant from another person.

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I have not had major surgery in the last 2 weeks or am fully recovered from any major surgery.

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My cancer has spread to my brain or spinal cord.

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I have been treated with immunotherapy targeting specific cancer growth pathways.

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I have an autoimmune disease treated with medication in the last 2 years.

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I am currently being treated for an infection.

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I am not taking strong or moderate inhibitors of CYP3A4 that can't be stopped for the study.

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I have been diagnosed with HIV.

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I have had a bone marrow or cord blood transplant.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I have active hepatitis B or C.

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I cannot take pills by mouth or have a condition that affects how my body absorbs medication.

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I do not have any uncontrolled heart conditions.

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I am not taking strong or moderate drugs that affect drug metabolism and can't stop them for the study.

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I have been treated with olaparib or another PARP inhibitor before.

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I have been diagnosed with MDS, AML, or conditions that suggest I might have them.

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I have active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

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

Thrombocytopenia

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2190

Pembrolizumab

2017

Completed Phase 3

~2810