Olaparib + Pembrolizumab + Carboplatin for Head and Neck Cancer

Palo Alto (17 mi)

Overseen byDouglas R. Adkins

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?In this study, patients with recurrent or metastatic head and neck squamous cell carcinoma will receive first line treatment with olaparib, pembrolizumab, and carboplatin. The primary hypothesis is that olaparib, pembrolizumab and carboplatin will result in an overall response rate (ORR) higher than the historical ORR observed with pembrolizumab, platinum and 5-FU.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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

My throat cancer is known to express p16.

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

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

I am 18 years old or older.

Exclusion Criteria

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

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

I have had an organ or stem cell transplant.

I have been treated with drugs targeting immune checkpoints.

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

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

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

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

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

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

I have an active tuberculosis infection.

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

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

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

I have or had lung inflammation that needed steroids.

My cancer has spread to my brain or spinal cord.

Treatment Details

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.

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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: