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Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

NCT04643379 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Olaparib

Supplied by Merck \& Co.

DRUG

Pembrolizumab

Supplied by Merck \& Co.

DRUG

Carboplatin

Commercially available

PROCEDURE

Peripheral blood draw

Baseline (cycle 1 day 1), cycle 2 day 1, and at disease progression

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Joseph Sanchez Foundation

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Douglas Adkins, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-07
Primary Completion
2025-10-16
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643379 on ClinicalTrials.gov