Substudy 06B: Phase 1/2 Umbrella Study of Combination Therapies in Esophageal Cancer
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Registration Number
- JPRN-jRCT2031220582
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable 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-PD1/PD-L1 based therapy.
- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis. - Has adequately controlled blood pressure (BP) with or without antihypertensive medications.
- 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.
- 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 received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- 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.
- 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.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- History of human immunodeficiency virus (HIV) infection.
- History of Hepatitis B or known active Hepatitis C virus infection.
- History of allogenic tissue/solid organ transplant.
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention.
- Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib.
- Has risk for significant GI bleeding, such as:
-Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization.
-Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During Safety Lead-in Phase<br>- Number of Participants Experiencing Adverse Events (AEs) During Safety Lead-in Phase<br>- Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase<br>- Objective Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method - Progression-Free Survival (PFS)<br>- Duration of Response (DOR)<br>- Overall Survival (OS)<br>- Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase<br>- Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase