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
  • End date
    Aug 18, 2024
  • participants needed
    400
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Investigator
Toll Free Number
Primary Contact
The Townsville Hospital ( Site 0107) (0.0 mi away) Contact
+25 other location
paclitaxel
cavities
monoclonal antibodies
measurable disease
carcinoma
squamous cell carcinoma
carboplatin
pembrolizumab
chemotherapy regimen
cetuximab
docetaxel
caries
mk-3475
metastatic head and neck squamous cell carcinoma

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
Treatment Capecitabine, Cetuximab, docetaxel, Paclitaxel, Pembrolizumab, Lenvatinib
Clinical Study IdentifierNCT04428151
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Squamous cell carcinoma or head and neck cancer or Squamous Cell Carcinoma of Head and Neck?
Do you have any of these conditions: Squamous cell carcinoma or head and neck cancer or Squamous Cell Carcinoma of the Head and Neck or Squamous Cell Carcinoma of Head and Neck?
Do you have any of these conditions: Squamous Cell Carcinoma of Head and Neck or head and neck cancer or Squamous cell carcinoma or Squamous Cell Carcinoma of the Head and Neck?
Do you have any of these conditions: Squamous cell carcinoma or Squamous Cell Carcinoma of Head and Neck or head and neck cancer or Squamous Cell Carcinoma of the Head and Neck?
Do you have any of these conditions: Squamous Cell Carcinoma of Head and Neck or Squamous Cell Carcinoma of the Head and Neck or Squamous cell carcinoma or head and neck cancer?
Do you have any of these conditions: Squamous Cell Carcinoma of Head and Neck or Squamous Cell Carcinoma of the Head and Neck or Squamous cell carcinoma or head and neck cancer?
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 verified 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 1 week after the last dose of lenvatinib, 3 months after the last dose of capecitabine and paclitaxel, and and 6 months after the last dose of docetaxel
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. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
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 1 month post lenvatinib, whichever occurs last (Arms 1 and 3), or during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab (Arm2)
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 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet