Status:
RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 th...
Detailed Description
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 acti...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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
Key Trial Info
Start Date :
May 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2029
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05319730
Start Date
May 16 2023
End Date
April 10 2029
Last Update
January 5 2026
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
Tucson, Arizona, United States, 85719
2
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
Los Angeles, California, United States, 90404
3
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
East Syracuse, New York, United States, 13057
4
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)
New York, New York, United States, 10032