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New treatment option for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Official title Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC
ClinicalTrials.gov ID: NCT06052839
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc).
Also referred to as Keytruda®.
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
- 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.
- Phase 2: a mid-size study of how well it works
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
- 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
You likely can't join if
- Patients should not have had prior systemic therapy alone administered in the recurrent/ or metastatic setting. If a patient received platinum based...
- A patient cannot have received prior anti-PD-1 or anti-PD-L1 monoclonal antibody (mAb) therapy as systemic therapy for the treatment of...
- 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...
- Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious...
- Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes of the patients R/M HNSCC.
See the full eligibility 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 people 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...
- Female people 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...
- Male people 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.
- 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...
- 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...
- 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. people with vitiligo, Grave's disease, or...
- 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...
- Known allergy or hypersensitivity to carboplatin, other platinum agents, pembrolizumab, or paclitaxel.
- Baseline neutrophil count of \< 1,500 cells/mm.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Pittsburgh, Pennsylvania, 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.