Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06036836

Patient View

This study evaluates the pathologic complete response rate in cSCC and objective response rate in pMMR endometrial cancer. Participants receive favezelimab/pembrolizumab or pembrolizumab via IV infusion, with lenvatinib administered orally in Cohort B. Eligibility criteria include specific tumor types and treatment history.

Patient Parameters

Program Overview

The purpose of this study is to evaluate pathologic complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) [Cohort A] and to evaluate lenvatinib in combination with coformulated favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in participants proficient in mismatch repair (pMMR) endometrial cancer (EC) [Cohort B].

Eligibility Criteria

Exclusion Criteria

All Cohorts

  • Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
  • History of allogeneic tissue/solid organ transplant

Cohort A only

  • Received prior radiotherapy to the index lesion (in-field lesion)
  • Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible

Cohort B

  • Has had major surgery within 3 weeks prior to first dose of study interventions
  • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • Has urine protein ≥1 g/24 hours
  • Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
  • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention

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