Anti-platelet + Pembro for H&N Tumors

NCT03245489 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 102727
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if anti-platelet therapy combined with anti-PD-1 immunotherapy can cause a more favorable immunologic response thatn with immunotherapy alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Effect of Pembro + antiplatelet on major cellular parameters

  Immunologic response profile will be measured by changes in major cellular parameters in peripheral blood mononuclear cells pheotyped by flow cytometry for MDSCs, T and B cell activation markers and polyclonal IFNy-production by CD4 and CD8 response after P/I stimulation) in pembrolizumab alone and pembrolizumab + antiplatelet therapy. Markers will be measured at baseline, end of the first regimen and end of the second regimen. Changes in cellular parameters from the previous timepoint will be evaluated using a repeated measures ANOVA model. Cellular parameters will be evaluated in aggregate to report the immunologic response.

  12 weeks

Secondary Outcomes (3)

• Effect of Pembro + antiplatelets on immunologic markers

  12 weeks

• Frequency of adverse events reported

  12 weeks

• Tumor response rate

  12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will be treated with Regimen A, followed by Regimen B. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks. Regimen B is pembrolizumab alone for 6 weeks.

Drug: Pembrolizumab; Drug: Clopidogrel; Drug: acetylsalicylic acid

Group 2

EXPERIMENTAL

Group 2 will be treated with Regimen B, followed by Regimen A. Regimen B is pembrolizumab alone for 6 weeks. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks.

Drug: Pembrolizumab; Drug: Clopidogrel; Drug: acetylsalicylic acid

Interventions

Pembrolizumab DRUG

200mg intravenous (IV) over 30 minutes

Also known as: Keytruda

Group 1; Group 2

Clopidogrel DRUG

75mg/day oral

Also known as: Plavix

Group 1; Group 2

acetylsalicylic acid DRUG

81mg/day oral

Also known as: ASA, aspirin

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has pathologic confirmation of recurrent or metastatic HNSCC, regardless of HPV status.
• Subject has tumor that expresses PD-L1 (Combined Positive Score \[CPS\] \> 1) as determined by an FDA-approved test or subject has experienced disease progression on or after platinum-containing chemotherapy.
• Subject's scans have been reviewed at head and neck tumor board to assess tumor involvement.
• Subject is 18 years of age or older.
• Subject has measurable disease according to RECIST 1.1. Tumor lesions situated in previously irradiated areas are considered measurable if progression has been demonstrated in such lesions.
• Subject has an ECOG performance status of 0 to 2
• Subject has estimated life expectancy of at least 3 months.
• Subject has adequate hematologic function, defined as:
• ANC \>1000 K/CUMM
• Hemoglobin \>8.0 Grams/dL
• Platelets \>75,000 K/CUMM
• INR \< 1.7
• Subject has adequate renal function, defined as estimated creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula.
• Subject has adequate hepatic function, defined as:
• Total bilirubin ≤ 1.5 x ULN

You may not qualify if:

• Subject is receiving concomitant immunosuppressive therapy, defined as:
• Immunosuppressants, including: tacrolimus, sirolimus, everolimus, cyclosporine, azathioprine, mycophenolate mofetil, antithymocyte globulin, basiliximab, belatacept
• Systemic corticosteroids (except for short term treatment of allergic reactions or for treatment of irAE). Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
• Chemotherapy
• Immunotherapy
• Monoclonal antibodies
• Concurrent anticancer treatment within 14 days before the start of trial treatment.
• Subject has had major surgery within the last 28 days.
• Subject has an underlying bleeding disorder.
• Subjects requiring re-irradiation to head and neck.
• Subject is receiving anticoagulation (see section 7.2 for medication examples). Subjects must have a washout period of 7 days from registration.
• Subject has HNSCC with abutment or encasement of the internal carotid artery, external carotid artery or common carotid artery or any of the arterial branches.
• Subject has a draining fistula or wound in the head/neck.
• Subject with known aneurysm or pseudoaneurysm of the head/neck related to surgery.
• Subject has uncontrolled CNS metastases. Subjects with previously treated brain metastases will be allowed if the brain metastases have been stable without CNS-directed therapy (such as radiation or surgery) or steroid treatment for for at least 4 weeks prior to registration.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

pembrolizumab; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• John Kaczmar, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: August 10, 2017
• Study Start: March 6, 2018
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)