Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) Clinical Trial in Pittsburgh, PA

Q: Is NCT06052839 recruiting in Pittsburgh, PA?

Yes, NCT06052839 is currently recruiting participants at its Pittsburgh, PA location. This recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc) clinical trial is actively enrolling qualified participants.

Q: How do I join the recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc) clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) Study in Pittsburgh

The rationale for the new sequence of pulsed dose chemotherapy proposed in this trial is based on the hypotheses that current standard dosing of chemotherapy plus pembrolizumab ultimately suppresses the immune system and has a negative effect on the efficacy of the anti-PD-1 monoclonal antibody (mAb) therapy and that chemotherapy given after anti-PD-1 mAb therapy is associated with higher efficacy.

Sponsor: Dan Zandberg

Who Can Participate

Inclusion Criteria

Recurrent/metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies.

PD-L1 Combined Positive Score (CPS) \>1

Age \> 18 years.

Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-2

Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1

Patients must have normal organ and marrow function as defined below:

absolute neutrophil count ≥1,000/mcL

platelets ≥100,000/mcL

total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN)

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN (≤ 5 X the institutional ULN for patients with liver metastasis)

Creatinine clearance ≥40 mL/min/1.73 m2 for patients with a creatinine levels above institutional normal.

Female subjects of childbearing potential should have a negative urine or serum pregnancy during the screening period and also prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 60 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.

Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 60 days after the last dose of study therapy.

Ability to understand and the willingness to sign a written informed consent document.

If known to have prior brain metastases, must not have evidence of active (enlarging and/or symptomatic lesions) brain disease on MRI/CT evaluation done within 30 days of consent.

Exclusion Criteria

Patients should not have had prior systemic therapy alone administered in the recurrent/ or metastatic setting. If a patient received platinum based systemic therapy which was completed more than 6 months prior to signing consent given as part of multimodal curative intent treatment for locally advanced HNSCC (This includes both definitive concurrent chemoradiation and adjuvant chemoradiation) the patient is still eligible,

A patient cannot have received prior anti-PD-1 or anti-PD-L1 monoclonal antibody (mAb) therapy as systemic therapy for the treatment of recurrent/metastatic disease. Patients that received anti-PD-1 or anti-PD-L1 mAb therapy as part of multimodality curative intent treatment of locally advanced disease are still eligible as long as it has been at least 1 year since prior therapy. Patients that received anti-PD-1 or anti-PD-L1 mAb therapy as part of radiation for locoregional recurrence will be eligible as long as it has been 1 year since prior therapy.

Squamous cell carcinoma of the skin or of salivary gland origin.

Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism or Sjogren's syndrome will not be excluded from the study.

Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.

Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes of the patients R/M HNSCC.

Peripheral sensory neuropathy \> grade 2 by CTCAE v5.0

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Known allergy or hypersensitivity to carboplatin, other platinum agents, pembrolizumab, or paclitaxel.

Baseline neutrophil count of \< 1,500 cells/mm.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT06052839) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) Treatment Options in Pittsburgh, PA

If you're searching for recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc) treatment options in Pittsburgh, PA, this clinical trial (NCT06052839) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc) clinical trials near you to find additional studies recruiting in your area.

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) Clinical Trial in Pittsburgh, PA

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