A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
Sponsored by Merck Sharp & Dohme LLC
About this study
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
The master protocol is MK-3475-U06. As of Protocol Amendment 5, the Pembrolizumab Plus MK-4830 Plus Paclitaxel/Irinotecan arm and the Pembrolizumab Plus MK-4830 Plus Lenvatinib arm are no longer actively enrolling participants.
Where this study is enrolling (4)
- Call 520-621-2449
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
Tucson, Arizona
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- Call 310-570-1453
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
Los Angeles, California
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- Call 315-472-7504
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
East Syracuse, New York
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- Call 816-898-9413
UPMC Hillman Cancer Center-UPMC ( Site 4904)
Pittsburgh, Pennsylvania
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Who can participate
Inclusion criteria
- ✓Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
- ✓Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
- ✓Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
- ✓Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Exclusion criteria
- ✕include but are not limited to the following:
- ✕Inclusion Criteria:
- ✕Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
- ✕Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
- ✕Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
- ✕Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
- ✕Exclusion Criteria:
- ✕Direct invasion into adjacent organs such as the aorta or trachea
- ✕Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy
- ✕Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- ✕Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- ✕Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- ✕Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
- ✕Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- ✕Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- ✕History of allogenic tissue/solid organ transplant
- ✕Clinically significant cardiovascular disease within 12 months from first dose of study intervention
- ✕Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization
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Trial data sourced from ClinicalTrials.gov.