Clinical Trial

Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in combination with Opdivo (nivilumab) for the treatment patients with of metastatic, advanced, or recurrent solid tumors. All participants will receive open-label AL3818 with nivolumab. Part 1 consists of a dose finding phase to determine the recommended phase 2 dosage of AL3818 with nivolumab. Part 2 consists of a dose expansion phase, evaluating the safety and efficacy of the combination in patients cohorts including metastatic, advanced, or recurrent soft tissue sarcomas, non-small cell lung cancer, and small cell lung cancer.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-11-13; most recent amendment 2025-02-21.
Status change: Recruiting → Active, Not Recruiting 2023-05-19
Trial Details
NCT Number NCT04165330
Lead Sponsor Sarcoma Oncology Research Center, LLC
Collaborators: Advenchen Laboratories, LLC
Conditions Solid Tumor, Adult, Soft Tissue Sarcoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer
Enrollment 56 participants
Start Date 2019-10-17
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-24