← Back to Search

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):
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 3 years)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
My recent tests show my bone marrow and organs are functioning well.
Select...
My blood clotting tests are within normal limits, or if on blood thinners, within the therapeutic range.
Select...
I will use a condom during treatment and for 3 months after, and my partner will use contraception if she can have children.
Select...
My cancer is a type of head and neck cancer that has returned or spread.
Select...
My disease cannot be cured or I am not eligible for local treatments.
Select...
My throat cancer is known to express p16.
Select...
My cancer can be measured by scans or physical exam.
Select...
I am postmenopausal or not pregnant.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My hemoglobin level is at least 10.0 g/dL without recent blood transfusions or erythropoietin.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 3 years) for reporting.

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 iRECIST
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Overall survival (OS)
+1 more

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
~2140
Pembrolizumab
2017
Completed Phase 2
~1950
Carboplatin
2014
Completed Phase 3
~6670
Peripheral blood draw
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,058 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,670 Total Patients Enrolled
Joseph Sanchez FoundationUNKNOWN

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04643379 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Olaparib + Pembrolizumab + Carboplatin AUC
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04643379 — Phase 2
Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04643379 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What disease does Olaparib typically help manage?

"Olaparib is most often used to treat cancer, but it can also be given to patients with other conditions like unresectable melanoma or microsatellite instability high."

Answered by AI

Are there any patients who have not yet been enrolled in this research project?

"The information available on clinicaltrials.gov suggests that this trial is still recruiting patients. This research project was initially advertised on August 7th, 2021 and has since been updated October 18th, 2022. They are looking for 30 individuals to participate at 1 site."

Answered by AI

How many individuals are being monitored in this clinical trial?

"That is correct, the trial information available on clinicaltrials.gov shows that this study is still open for enrollment. This particular trial was first posted on 8/7/2021 and was last edited on 10/18/2022. The goal is to have 30 patients enrolled from 1 site."

Answered by AI

What is the extent of research on Olaparib's effects?

"At this time, there are a total of 1755 clinical trials underway for Olaparib. Of these active studies, 333 have reached Phase 3 testing. The largest number of trial locations for Olaparib are in Shanghai, but there are 78412 sites running trials globally."

Answered by AI

What are the potential risks associated with Olaparib use?

"At the moment, Olaparib has only been proven safe in Phase 2 trials. Therefore, it receives a score of 2."

Answered by AI
~12 spots leftby Nov 2025