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A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

Status
Closed
Cancer Type
Head and Neck Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04199104
Protocol IDs
7902-010 (primary)
MK-7902-010
NCI-2020-00576
2019-003717-34
205240
LEAP-10
Study Sponsor
Merck Sharp & Dohme LLC

Summary

This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a
first line intervention in a PD-L1 selected population with participants with recurrent or
metastatic head and neck squamous cell carcinoma.

Hypotheses include:

- Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST 1.1) by blinded independent central review (BICR).

- Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.

- Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to
overall survival (OS).

Eligibility

  1. Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies. Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV.
  2. Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
  3. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period
  4. Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last
  5. Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
  6. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
  7. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
  8. Have adequately controlled blood pressure with or without antihypertensive medications.
  9. Has adequate organ function.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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