Study on AL3818 and Nivolumab for Treating Advanced Solid Tumors

Sponsor: Sarcoma Oncology Research Center, LLC

Sponsor score: 0

ClinicalTrials ID:NCT04165330

Provider View

This clinical trial is testing a new treatment combining AL3818 and Nivolumab to see if it is safe and effective for adults with advanced, spreading, or returning solid tumors. The study will determine the best dose and evaluate the treatment's impact on different types of cancer, including soft tissue sarcomas and lung cancers.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment combining AL3818 (anlotinib) and Nivolumab (Opdivo) for patients with advanced, spreading, or returning solid tumors. The study is divided into two parts: the first part will find the best dose of AL3818 to use with Nivolumab, and the second part will test this combination on different types of cancer, such as soft tissue sarcomas, non-small cell lung cancer, and small cell lung cancer.

Description

This study is designed to test a new treatment that combines AL3818 (anlotinib) with Nivolumab (Opdivo) for patients with advanced, spreading, or returning solid tumors. The study has two main parts:

  • Part 1 (Phase 1b): This phase will determine the safest and most effective dose of AL3818 when used with Nivolumab. Participants will take AL3818 by mouth once a day for 14 days and receive Nivolumab injections on the first and fifteenth day of a 21-day cycle.

  • Part 2 (Phase 2a): This phase will test the combination treatment on specific cancers, including soft tissue sarcomas, non-small cell lung cancer, and small cell lung cancer. The treatment will be given in 21-day cycles, with AL3818 taken orally for 14 days and Nivolumab given every two weeks, for up to 24 cycles.

The study aims to find out if this combination can help control these cancers and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Have advanced, spreading, or returning solid tumors that need further treatment, or have tumors for which no standard treatment exists.
  • For Part 2, have confirmed soft tissue sarcomas, non-small cell lung cancer, or small cell lung cancer needing further treatment.
  • Have measurable disease that can be tracked using standard criteria.
  • Have experienced disease progression or recurrence within 6 months before joining the study.
  • Have not received any anti-cancer treatment for at least 21 days before starting the study treatment.
  • Have a life expectancy of at least 3 months.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Have a heart function of more than 50% as measured by specific tests.
  • Have controlled blood pressure readings.
  • Be willing to provide written informed consent before starting the study.

Exclusion Criteria

  • Have had major surgery within 28 days or minor surgery within 7 days before starting the study treatment.
  • Have another primary cancer that could interfere with the study treatment.
  • Have untreated or active cancer spread to the brain or spinal cord.
  • Have certain autoimmune diseases or lung diseases.
  • Be taking corticosteroids or other immunosuppressive medications within 14 days before starting the study treatment.
  • Have active gastrointestinal conditions that increase the risk of complications.
  • Have untreated deep vein thrombosis within the past 6 months.
  • Have an uncontrolled infection.
  • Have severe heart conditions or recent heart-related events.
  • Have non-healing wounds or significant bleeding issues.
  • Have a prolonged QT interval on an ECG.
  • Have HIV with a low CD4+ count.
  • Have active hepatitis B or C infections.
  • Have a history of organ transplantation.
  • Have conditions affecting the intake or absorption of AL3818.
  • Have known allergies or intolerances to protein-based therapies or significant drug allergies.

Locations

FACILITYZIPCITYSTATE
Sarcoma Oncology Research Center90403Santa MonicaCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.