Study of Favelizimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
Solid Tumor, Cutaneous Squamous Cell Carcinoma, Endometrial Cancer
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death-2 (PD2, PD-2), Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1), Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2), Lymphocyte-Activation Gene 3 (LAG-3)
Eligibility Criteria
Inclusion Criteria Cohort A only Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted) Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 9 Is systemic treatment naïve Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent Cohort B only Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report Documented evidence of stage IVB (per International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention) Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent Has adequately controlled blood pressure without antihypertensive medication All Cohorts Agrees to follow contraception guidelines if a participant of childbearing potential Has a life expectancy >3 years per investigator assessment Has adequate organ function Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization If positive for hepatitis C, has undetectable viral load at screening If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy 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
Sites / Locations
- Blacktown Hospital ( Site 0003)Recruiting
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 0032)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Favezelimab/Pembrolizumab
Pembrolizumab
Favezelimab/Pembrolizumab + Lenvatinib (Cohort B)
Pembrolizumab + Lenvatinib (Cohort B)
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for up to 3 cycles in the neoadjuvant period and up to 14 cycles of adjuvant therapy. Each cycle is 21 days.
Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for up to 3 cycles in the neoadjuvant period and up to 14 cycles of adjuvant therapy. Each cycle is 21 days.
Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.