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Alkylating Agent

Olaparib + Pembrolizumab + Carboplatin for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Douglas Adkins, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine <1.5 x ULN or creatinine clearance ≥ 51 mL/min by Cockcroft-Gault or based on a 24-hour urine test

Normal bone marrow and organ function as defined below (specimens must be collected within 10 days prior to the start of study treatment):

Must not have

Has an active autoimmune disease (i.e. rheumatoid arthritis, lupus, Sjogren's syndrome) that has required IV or subcutaneous systemic treatment in the past 2 years (excluding Rituxan). Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St. John's wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new treatment for head and neck cancer that could be more effective than the standard of care.

Who is the study for?

Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who haven't had certain prior treatments, have measurable disease, good organ function, no serious allergies to study drugs, can swallow pills, and are not pregnant. Men must use contraception.

What is being tested?

The trial tests a combination of Olaparib with Pembrolizumab and Carboplatin as the first line of treatment for HNSCC. It aims to see if this combo improves response rates compared to historical data from similar treatments.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, blood-related issues like anemia or clotting problems, kidney function changes, fatigue, potential heart complications from Carboplatin and immune-related effects from Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My recent tests show my bone marrow and organs are functioning well.

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My cancer is a type of head and neck cancer that has returned or spread.

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My disease cannot be cured or I am not eligible for local treatments.

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My throat cancer is known to express p16.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My hemoglobin level is at least 10.0 g/dL without recent blood transfusions or erythropoietin.

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I am 18 years old or older.

Exclusion Criteria

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

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I haven't needed strong medication for an autoimmune disease in the last 2 years.

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I am not currently using strong or moderate drugs that affect liver enzymes.

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I have had an organ or stem cell transplant.

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I have been treated with drugs targeting immune checkpoints.

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I am not currently taking strong or moderate CYP3A inhibitors, or I can stop them for 2 weeks before starting olaparib.

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I have no allergies to olaparib, pembrolizumab, carboplatin, or similar drugs.

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I had major surgery more than 2 weeks ago and have recovered from it.

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I have a serious health condition that is not under control.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I have a history of Hepatitis B or active Hepatitis C.

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I have an active tuberculosis infection.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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My cancer worsened within 6 months after treatment meant to cure it.

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I have received treatment for cancer that came back or spread.

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I have or had lung inflammation that needed steroids.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 + Pembrolizumab + Carboplatin AUCExperimental Treatment4 Interventions

-Patients enrolled in this study will receive olaparib, pembrolizumab and carboplatin in three-week cycles for six cycles, followed by maintenance therapy with three-week cycles of olaparib and pembrolizumab. Treatment will continue until disease progression, intolerable toxicity, patient or physician decision to stop therapy, or after 35 cycles, whichever occurs first. Drug dosing for each cycle is as follows: * Olaparib 200 mg twice per day (bid) by mouth (po) Days 1-10 for the first six cycles (when given with carboplatin), followed by 400 mg bid po Days 1-21 of subsequent cycles. * Pembrolizumab 200 mg intravenous (IV) Day 1. * Carboplatin AUC 5 IV on Day 1 for up to six cycles.

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