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ACTIVE NOT RECRUITING Phase 1

Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors

NCT04165330 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG AL3818
  • DRUG Nivolumab Injection

Study Locations (1)

California

  • Sarcoma Oncology Research Center — Santa Monica

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2019-10-17
Est. Completion 2028-03-31
Phase Phase 1

Sponsor

Sarcoma Oncology Research Center

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04165330

The ClinicalTrials.gov registry entry for NCT04165330 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarcoma Oncology Research Center, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which AL3818 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04165330 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04165330 about?

NCT04165330 is a clinical study titled "Evaluation of AL3818 in Combination With Nivolumab in Solid Tumors". 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 findin...

What is the current status of trial NCT04165330?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2019-10-17. Estimated completion is 2028-03-31.

What conditions does trial NCT04165330 study?

This clinical trial studies the following conditions: Non Small Cell Lung Cancer, Solid Tumor, Adult, Soft Tissue Sarcoma, Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04165330?

The interventions under investigation include: AL3818 (DRUG), Nivolumab Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04165330?

This trial is sponsored by Sarcoma Oncology Research Center, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04165330 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial