ACTIVE_NOT_RECRUITING

Pembrolizumab Plus Olaparib in LA-HNSCC

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Conditions

Squamous Cell Carcinoma of Head and Neckhead and necksquamous cell carcinomaHPV negativepembrolizumabolaparibPARP inhibitoranti-PD1 inhibitorintensity modulation radiation therapyProton therapycisplatin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to evaluate the effectiveness of using a combination of pembrolizumab and olaparib when given before and after standard chemoradiation therapy in treating locally advanced head and neck squamous cell carcinoma. Pembrolizumab and olaparib are drugs that are approved for head and neck cancer treatment. However, FDA has not approved the use of these two drugs together in treating head and neck cancer.

Official Title

A Phase II Trial of Induction and Maintenance Pembrolizumab and Olaparib in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2022-09-02
Study Completion:2030-11-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05366166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>18 years on the day of signing the consent
  2. 2. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  3. 3. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee. The subject must be willing to consent to a mandatory pre-study biopsy unless sufficient archival tissue is available.
  4. 4. Biopsy confirmed American Joint Committee on Cancer 8th Edition35 stage III-IV B oral cavity squamous cell carcinoma (SCC), p16-negative oropharyngeal SCC, stage III-IVB hypopharyngeal SCC, stage III-IVB laryngeal SCC -OR- HPV-associated oropharyngeal SCC (p16 positive or HPV-associated) T4 or N3 , T1-3 N2 or T3N0-1 with \>10 pack-year tobacco history
  5. 5. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by imaging (CT/ PET) and is suitable for repeated assessment.
  6. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  7. 7. No prior curative attempts for this cancer (i.e., surgery, radiation, systemic therapy) and not currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of the study intervention. No evidence of metastatic disease (M0)
  8. 1. Subjects with prior and concurrent malignancies of different tumor types whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drug are eligible with the following exception: Subjects with prior history of HNSCC treated \< 3 years to the date of consent.
  9. 2. Cisplatin-ineligible as defined in the protocol.
  10. 3. Severe, active medical comorbidity. Subjects are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan or any psychiatric disorder that prohibits obtaining informed consent.
  11. 4. Subjects unable to swallow orally administered medication prior to initiation of study treatment.
  12. 5. Systemic glucocorticoids for any purpose other than to modulate symptoms from an event of clinical interest of suspected immunologic etiology
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Siddharth Sheth, DO MPH
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
University of Louisville, Brown Cancer Center
Louisville, Kentucky, 40202
United States
UNC Lineberger
Chapel Hill, North Carolina, 27514
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Siddharth Sheth, DO MPH, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-02
Study Completion Date2030-11-21

Study Record Updates

Study Start Date2022-09-02
Study Completion Date2030-11-21

Terms related to this study

Keywords Provided by Researchers

  • head and neck
  • squamous cell carcinoma
  • HPV negative
  • pembrolizumab
  • olaparib
  • PARP inhibitor
  • anti-PD1 inhibitor
  • intensity modulation radiation therapy
  • Proton therapy
  • cisplatin

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma of Head and Neck