Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

STATUS

Recruiting
participants needed

400
sponsor

Merck Sharp & Dohme Corp.

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Updated on 19 February 2024

See if I qualify

measurable disease

carboplatin

solid tumour

pembrolizumab

docetaxel

squamous cell carcinoma of head and neck

squamous cell carcinoma

paclitaxel

monoclonal antibodies

programmed cell death protein 1

monoclonal antibody therapy

cavity

carcinoma

capecitabine

mk-3475

cetuximab

antihypertensive

monoclonal protein

cavities

metastatic head and neck squamous cell carcinoma

caries

antibody therapy

lenvatinib

contraceptive use

antihypertensive agents

cisplatin

metastatic head and neck squamous cell cancer

Summary

This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that pembrolizumab + lenvatinib is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

Details

Condition	Squamous cell carcinoma, Squamous cell carcinoma, head and neck cancer, head and neck cancer
Age	18-100 years
Treatment	Pembrolizumab, Paclitaxel, Capecitabine, Cetuximab, Lenvatinib, Docetaxel
Clinical Study Identifier	NCT04428151
Sponsor	Merck Sharp & Dohme Corp.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies
	Disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen
	Disease progression on or after treatment with an anti-PD-1/PD-L1 mAb (programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody)
	Pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, following initiation of treatment with a PD-1/PD-L1 inhibitor
	Measurable disease by CT or MRI based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as confirmed by blinded independent central review (BICR). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
	ECOG performance status of 0 or 1 assessed within 7 days of the first dose of study intervention
	Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of pembrolizumab \+ lenvatinib (Arm 1) or lenvatinib monotherapy (Arm 3), and 180 days after the last dose of standard of care (SOC) chemotherapy (Arm 2)
	Refrain from donating sperm
	Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
	Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
	A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies
	Is not a woman of childbearing potential (WOCBP)
	Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last (Arms 1 and 3), or during the intervention period and for at least 180 days after the last dose of SOC chemotherapy (Arm 2)
	Female participants who randomize to Arm 2 must also agree not to donate or freeze/store eggs during the intervention period and for at least 180 days after the last dose of SOC chemotherapy
	Adequately controlled blood pressure (BP) with or without antihypertensive medications
	Adequate organ function
Exclusion Criteria
	Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors
	Disease that is suitable for local therapy administered with curative intent
	Life expectancy of less than 3 months and/or has rapidly progressing disease in the opinion of the treating investigator
	History of noninfectious pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease
	Active infection requiring systemic therapy
	Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
	Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
	Known additional malignancy that is progressing or has required active systemic treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ that have undergone potentially curative therapy
	Active autoimmune disease that has required systemic treatment in the past 2 years
	Had an allogeneic tissue/solid organ transplant
	Known history of human immunodeficiency virus (HIV) infection
	History of hepatitis B or known active hepatitis C virus
	History of any contraindication or has a severe hypersensitivity to any components of pembrolizumab, lenvatinib or SOC chemotherapy
	Pre-existing Grade 3 gastrointestinal or non-gastrointestinal fistula
	History of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption
	Had major surgery within 3 weeks prior to first dose of study interventions
	Clinically significant cardiovascular impairment within 12 months of the first dose of study drug
	Active tuberculosis
	Difficulty swallowing capsules or ingesting a suspension either orally, by a nasogastric (NG) tube, or by a gastrostomy tube
	Prior treatment with lenvatinib
	Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1 or has not recovered from adverse events (AEs) due to a previously administered agent
	Received a live vaccine within 30 days of planned start of study intervention
	Previously treated with 4 or more systemic regimens given for recurrent/metastatic disease
	Currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention
	Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

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Study Definition

Wikipedia

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)