RECRUITING

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

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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

Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.

Official Title

An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2023-05-30

Study Completion:2026-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05814666

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 Criteria	Exclusion Criteria
1. Must have given written informed consent (signed and dated). 2. Aged ≥18 years at the time of informed consent. 3. Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. 4. Presence of measurable tumor per RECIST v1.1 criteria. 5. Detectable PD-L1 expression in tumor, defined as CPS ≥1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test. 6. Baseline fresh tumor biopsy or archival specimen. 7. ECOG performance status of 0 or 1. 8. Adequate organ function within 10 days of study treatment, 9. Oxygen saturation on room air ≥92% by pulse oximetry. 10. Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control. 11. Males must be surgically sterile or agree to adequate birth control. 12. Has an estimated life expectancy of at least 3 months. 13. Has recovered from all complications or surgery and all toxicities of prior therapy	1. Prior therapy for metastatic HNSCC. 2. Has disease suitable for local therapy with curative intent. 3. Primary tumor of the nasopharynx. 4. Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2). 5. Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment. 6. Known autoimmune disease that has required systemic treatment 7. Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of \>10 mg prednisone daily 8. Prior allogeneic tissue/solid organ transplant. 9. Has significant cardiovascular disease 10. Has received a live vaccine within 30 days 11. Active infection requiring systemic antiviral or antimicrobial therapy 12. History of (non-infectious) pneumonitis that required steroids or current pneumonitis. 13. History of other malignancies 14. Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks 15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 16. Treated or untreated parenchymal brain metastases or leptomeningeal disease. 17. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent (if known), whichever is longer. 18. Hypersensitivity to any component of danvatirsen or pembrolizumab.

Inclusion Criteria

Exclusion Criteria

1. Must have given written informed consent (signed and dated).
2. Aged ≥18 years at the time of informed consent.
3. Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
4. Presence of measurable tumor per RECIST v1.1 criteria.
5. Detectable PD-L1 expression in tumor, defined as CPS ≥1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test.
6. Baseline fresh tumor biopsy or archival specimen.
7. ECOG performance status of 0 or 1.
8. Adequate organ function within 10 days of study treatment,
9. Oxygen saturation on room air ≥92% by pulse oximetry.
10. Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control.
11. Males must be surgically sterile or agree to adequate birth control.
12. Has an estimated life expectancy of at least 3 months.
13. Has recovered from all complications or surgery and all toxicities of prior therapy

1. Prior therapy for metastatic HNSCC.
2. Has disease suitable for local therapy with curative intent.
3. Primary tumor of the nasopharynx.
4. Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).
5. Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment.
6. Known autoimmune disease that has required systemic treatment
7. Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of \>10 mg prednisone daily
8. Prior allogeneic tissue/solid organ transplant.
9. Has significant cardiovascular disease
10. Has received a live vaccine within 30 days
11. Active infection requiring systemic antiviral or antimicrobial therapy
12. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
13. History of other malignancies
14. Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks
15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
16. Treated or untreated parenchymal brain metastases or leptomeningeal disease.
17. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent (if known), whichever is longer.
18. Hypersensitivity to any component of danvatirsen or pembrolizumab.

Contacts and Locations

Study Contact

Flamingo Therapeutics

CONTACT

484 482 0007

clinical@flamingotx.com

Study Locations (Sites)

The University of Arizona Cancer Center

Tucson, Arizona, 85719

United States

University of California Irvine (UCI)

Irvine, California, 92617

United States

TMPN Hunt Cancer Care

Torrance, California, 90505

United States

University of California Los Angeles

Westwood, California, 90024

United States

University of Colorado Hospital (UCH) Anschutz Cancer Pavilion

Aurora, Colorado, 80045

United States

Miami Cancer Institute

Miami, Florida, 33176

United States

University of Illinois Cancer Center

Chicago, Illinois, 60612

United States

AMR Kansas City Oncology

Merriam, Kansas, 66204

United States

University of Kansas Medical Center

Westwood, Kansas, 66205

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169

United States

Morristown Medical Center

Morristown, New Jersey, 07960

United States

Mount Sinai

New York, New York, 10029

United States

Stony Brook Cancer Center

Stony Brook, New York, 11794

United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45229

United States

University Hospitals Cleveland

Cleveland, Ohio, 44106

United States

Prisma Health Cancer Institute

Greenville, South Carolina, 29605

United States

Collaborators and Investigators

Sponsor: Flamingo Therapeutics NV

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 Date2023-05-30

Study Completion Date2026-05-30

Study Record Updates

Study Start Date2023-05-30

Study Completion Date2026-05-30

Terms related to this study

Additional Relevant MeSH Terms

HNSCC