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Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers

NCT03190174 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-02-17

Study results available
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Summary

This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mammalian target of rapamycin (mTOR) inhibitor nab-rapamycin (ABI-009) in advanced Ewing's sarcoma, perivascular epithelioid cell tumor (PEComa), epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, high microsatellite instability (MSI-H)/ mismatch repair deficient (dMMR) metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors.

Conditions

Interventions

DRUG

Nab-Rapamycin

Escalating doses of ABI-009 will be given IV over 30 min for 2 of every 3 weeks beginning Day 8 Cycle 2. Only nivolumab will be given in Cycle 1. At Dose Level 1, 3-6 patients will receive 56 mg/m\^2; at Dose Level 2, 3-6 six patients will receive 75 mg/m\^2; and at Dose Level 3, 3-6 patients will receive 100 mg/m\^2.

BIOLOGICAL

Nivolumab

A defined dose of nivolumab, 3 mg/kg, will be given IV over 30 minutes q 3 weeks

Sponsors & Collaborators

  • Aadi Bioscience, Inc.

    collaborator INDUSTRY

  • Sarcoma Oncology Research Center, LLC

    lead OTHER

Principal Investigators

  • Erlinda M Gordon, MD · Sarcoma Oncology Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2021-12-01
Completion
2021-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190174 on ClinicalTrials.gov