Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Launched by MERCK SHARP & DOHME LLC · May 2, 2023

Keywords

ClinConnect Summary

This clinical trial, called MK-0472-001, is studying a new treatment called MK-0472 for patients with advanced or metastatic solid tumors, which are types of cancer that have spread beyond their original location. The aim is to see how effective and safe MK-0472 is when given alone or alongside other treatments like pembrolizumab. This study is currently looking for participants aged 65 to 74 who have already tried all other available treatments for their cancer but are still experiencing disease progression. To qualify, participants must have a confirmed diagnosis of their cancer and meet certain health criteria, including those related to viral infections like hepatitis and HIV.

If you decide to participate, you will receive regular doses of the study medication and will be monitored closely for any side effects or how well the treatment is working. It's important to know that there are specific health conditions that may prevent participation, such as certain eye diseases or active infections. Overall, this trial offers a chance for eligible patients to access a new potential treatment option while contributing to important cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic
• • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment
• • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• • Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (\>4 weeks) antiretroviral therapy (ART)
• • Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit
• • Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 protein (PD-1)/ligand 1 (L1) therapies are eligible. Tumor types permitted include: melanoma, non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK)/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma
• • Arm 3: Has histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• • Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study
• • Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
• • History of hyperparathyroidism or hypercalcemia
• • Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease
• • Has clinically significant cardiovascular disease
• • Bullous exfoliative skin disorders of any grade
• • Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients
• • Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing
• • Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event
• • Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose
• • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
• • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
• • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention
• • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
• • Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• • Has active infection requiring systemic therapy
• • Has history of allogeneic tissue/solid organ transplant
• • Have not adequately recovered from major surgery or have ongoing surgical complications