BridgeMD
New treatment option for Locally Recurrent Head and Neck Squamous Cell Carcinoma
Official title Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06211335
What this study is testing
What is Losartan?
Losartan is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally recurrent head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase Ib trial tests the safety, side effects and how well losartan, pembrolizumab and stereotactic body radiation therapy (SBRT) for the treatment of patients with head and neck squamous cell carcinoma that has come back to nearby tissue or lymph node after a period of improvement (locally recurrent), that has not responded to previous treatment (refractory) or that has spread from where it first started to multiple other placed in the body (oligometastatic). Losartan is a drug used to treat high blood pressure that may enhance the effects of other cancer treatments such as immunotherapy and radiation.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed locoregionally recurrent, refractory, or oligometastatic (at most 4 lesions) squamous cell carcinoma of the...
- p16 status known for base of tongue, soft palate, and tonsil cancers
- Tumor amenable to sequential biopsies, and patients willing to undergo sequential tumor biopsies so long as the treating investigator considers them...
- Prior radiotherapy to the head and neck is allowed. Disease should be limited to up to 4 sites of active disease in the head and neck and/or distant...
- Prior systemic therapy is allowed. Patients with locoregional relapses where radiation alone would be indicated are allowed to enroll without prior...
You likely can't join if
- Nasopharyngeal carcinoma, salivary gland carcinoma or primary skin squamous cell carcinoma (SCC)
- Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody
- Chemotherapy or other anti-cancer therapy within 3 weeks prior to study day 1
- Hypersensitivity to losartan or any component of the formulation
- Radiation therapy within 6 months prior to study day 1
- Patients with disease surrounding \> 50% of the carotid
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed locoregionally recurrent, refractory, or oligometastatic (at most 4 lesions) squamous cell carcinoma of the head and neck not amenable to curative resection
- p16 status known for base of tongue, soft palate, and tonsil cancers
- Tumor amenable to sequential biopsies, and patients willing to undergo sequential tumor biopsies so long as the treating investigator considers them to be clinically safe
- Prior radiotherapy to the head and neck is allowed. Disease should be limited to up to 4 sites of active disease in the head and neck and/or distant metastatic sites if deemed safely treatable by physician, or adjacent...
- Prior systemic therapy is allowed. Patients with locoregional relapses where radiation alone would be indicated are allowed to enroll without prior systemic therapy
- Presence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) with a target on a computed tomography (CT) scan or magnetic resonance imaging (MRI) available for review
- Combined positive score (CPS) \> 1%
- Age ≥ 18 years at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Leukocytes ≥ 3 × 10\^9/L
- Absolute neutrophil count ≥ 1.5 × 10\^9/L
- Platelets ≥ 100 × 10\^9/L
- Hemoglobin (Hgb) ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- Aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 × institutional ULN
- Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m\^2 for patients with creatinine above institutional ULN
- The effects of losartan on the developing human fetus are unknown. For this reason, individuals of childbearing potential and male participants with partners of childbearing potential, must agree to use methods of...
- Ability to understand and willingness to sign and date the informed consent form
- Stated ability and willingness to adhere to the study visit schedule and protocol requirements
What rules you out
- Nasopharyngeal carcinoma, salivary gland carcinoma or primary skin squamous cell carcinoma (SCC)
- Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody
- Chemotherapy or other anti-cancer therapy within 3 weeks prior to study day 1
- Hypersensitivity to losartan or any component of the formulation
- Radiation therapy within 6 months prior to study day 1
- Patients with disease surrounding \> 50% of the carotid
- Participant who has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 from an adverse event (AE) due to previous cancer therapeutics (i.e., chemotherapy...
- Major surgery as assessed by the investigator (with the exception of diagnostic biopsy) within ≤ 28 days prior to study day 1 (patients must have completely recovered from any previous surgery prior to study day 1)
- Clinically significant bleeding ≤ 4 weeks prior to study day 1
- Requirement for parenteral antibiotics, or any active infection requiring parenteral antibiotic therapy within 4 weeks prior to study day 1
- Clinically significant or uncontrolled diabetes mellitus (hemoglobin A1C ≤ 8.5%). Patients with diabetes mellitus treated with aliskiren ≤ 7 days prior to study day 1 are excluded
- Active autoimmune disorders that have required systemic treatment with disease modifying agents, corticosteroids, or immunosuppressive drugs in the past 2 years are excluded. Patients with autoimmune disorder or...
- Current use of systemic corticosteroids equivalent to \>10 mg of prednisone per day
- Current use of angiotensin receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors for management of hypertension
- Clinically significant cardiovascular, pulmonary, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor that in the judgment of the investigator should preclude treatment...
- Any other active malignancy except for low-risk prostate cancer previously treated or under active surveillance, uncomplicated and cured basal cell carcinoma, or squamous cell carcinoma of the skin within 5 years of...
- Known history of positive hepatitis C (HCV) antibody, hepatitis B (HBV) surface antigen (HbsAg and HBV core Ab positive), or human immunodeficiency virus (HIV) antibody results. Patients with positive antibody tests are...
- Administration of live, attenuated vaccine ≤ 28 days prior to study day 1. Administration of inactivated flu vaccines is allowed
- Any prior treatment with losartan or other specific TGF-β-directed therapy
- Treatment with another investigational drug or device, or approved therapy for investigational use ≤ 28 days prior to study day 1, or if the half-life of the previous product is known, within 5 times the half-life prior...
- Pregnant or breast feeding
- Any condition that in the opinion of the investigator would interfere with the participant's safety, compliance while on trial, or understanding or rendering of informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.